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A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

NNC0114-0006

liraglutide

placebo

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2
BMI (body mass index) higher or equal to 18.5 kg/m^2
Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening
Insulin dependence unless in temporary spontaneous remission (honeymoon period)

Exclusion Criteria:

Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)
History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)
History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
Vaccination within 4 weeks before randomisation, Visit 3 (V3)
Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)
History of pancreatitis (acute or chronic)
Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
Any past or current diagnosis of malignant neoplasms
Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

NNC0114-0006 + Liraglutide

NNC0114-0006 + Placebo

Liraglutide + Placebo

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L).

Secondary Outcome Measures

AUC0-2h of C-peptide at Week 54 Relative to Baseline

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.

Cmax of C-peptide at Week 54 Relative to Baseline

Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).

AUC0-4h of Glucose at Week 54 Relative to Baseline

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L).

AUC0-2h of Glucose at Week 54 Relative to Baseline

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol*h/L'.

Cmax of Glucose at Week 54 Relative to Baseline

Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.

Number of Treatment Emergent Adverse Events

An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

Number of Treatment Emergent Hyperglycaemic Episodes

Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

Number of Treatment Emergent Episodes of Diabetic Ketoacidosis

Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion

Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented.

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)

Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia.

Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions

Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.

Change in Body Weight (kg)

Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.

Diabetes Retinopathy

Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.

Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline

The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline.

Change in Haematology: Erythrocytes

Change in erythrocytes (measured in 10^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Haematocrit

Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Haemoglobin

Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Leukocytes

Change in leukocytes (measured in 10^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Mean Corpuscular Hemoglobin

Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Mean Corpuscular Hemoglobin Concentration

Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Mean Corpuscular Volume

Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Thrombocytes

Change in thrombocytes (measured in 10^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Eosinophil

Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Neutrophils

Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Basophils

Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Lymphocytes

Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Haematology: Monocytes

Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Alanine Aminotransferase (ALAT)

Change in ALAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Albumin

Change in albumin (measured in gram per deciliter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Amylase

Change in amylase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Alkaline Phosphatase (ALP)

Change in ALP (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Aspartate Aminotransferase (ASAT)

Change in ASAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Total Bilirubin

Change in Total bilirubin (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Calcium Corrected

Change in calcium corrected (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Chloride

Change in chloride (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Creatine Kinase

Change in creatine kinase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Creatinine

Change in creatinine (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Gamma-glutamyl Transferase (GGT)

Change in GGT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: C-reactive Protein Serum

Change in C-reactive protein serum (measured in milligrams per liter [mg/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Lactate Dehydrogenase

Change in Lactate Dehydrogenase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Lipase

Change in lipase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Magnesium

Change in magnesium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Phosphate

Change in phosphate (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Potassium

Change in potassium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Sodium

Change in sodium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Total Protein

Change in total protein (measured in gram per liter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Blood Urea Nitrogen Serum

Change in blood urea nitrogen serum (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Biochemistry: Uric Acid

Change in Uric Acid (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in International Normalised Ratio (INR)

Change in INR (measured in ratio]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in D-Dimer

Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Lipids: Total Cholesterol (Ratio to Baseline)

Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Lipids: Free Fatty Acids (Ratio to Baseline)

Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Lipids: HDL Cholesterol (Ratio to Baseline)

Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Lipids: LDL Cholesterol (Ratio to Baseline)

Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Lipids: Triglycerides (TG) (Ratio to Baseline)

Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Total Immunoglobulin E (IgE)

Change in IgE (measured in kilo international units per liter [kIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Urinalysis: Urine Dipsticks

Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented.

Change in Cytokines: Interleukin (IL)-6

IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Change in Cytokines- Interleukin (IL)-10

IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Change in Cytokines: Interleukin (IL)-17

IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Change in Cytokines: Interferon (IFN) Gamma

IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Change in Cytokines: TNF-alpha

TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Change in Hormone Level: Thyroid Stimulating Hormone (TSH)

Change in TSH (measured in milli international units per liter [mIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Hormone Level: Calcitonin

Change in Calcitonin (measured in nanogram per liter [ng/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Systolic and Diastolic Blood Pressure

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.

Change in Pulse

Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80

Change in Body Temperature

Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.

Change in Respiratory Rate

Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.

Change in Electrocardiogram (ECG)

The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented.

Change in Eye-examination

Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented.

Change in Physical Examination

Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented.

Occurrence of Anti-NNC0114-0006 Antibodies

This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented.

Occurrence of Anti-liraglutide Antibodies

This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented.

Change in Insulin Dose

The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented.

Change in Number of Insulin Injections

The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented.

Number of Weeks Off Bolus Insulin

The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.

Change in HbA1c

Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.

Change in Fasting Plasma Glucose

Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.

Change in Fasting C-peptide- Ratio to Baseline

Change in fasting C-peptide (measured in nanomole per liter [nmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Change in Fasting Glucagon- Ratio to Baseline

Change in fasting glucagon (measured in picogram per milliliter [pg/mL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

7-point SMPG Profiles

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80.

Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.

Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.

Change in Mean of 7-point Profiles

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.

Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.

Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)

AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Terminal Half-life (t½) After Last Dose of NNC0114-0006

Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)

The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)

Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)

This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.

Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)

Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)

Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)

C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Liraglutide Concentration at Steady State (C Liraglutide)

C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.

Change in Biomarker: Immune Phenotyping- B Cell Panel

B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative.

Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel

NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation.

Change in Biomarker: Immune Phenotyping- T Cell Panel

T cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CD refer to Cluster of Differentiation; TEMRA refers to terminally differentiated effector memory cells re-expressing CD45RA; CCR refers to C-C chemokine receptor; TREG refers to Regulatory T cells.

Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel

TfH cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table CTFH refer to Circulating T follicular helper; ICOS refers to inducible T-cell co-stimulator; PD refers to Programmed cell death protein; CCR refers to C-C chemokine receptor; CXCR refers to C-X-C chemokine receptor; CD refer to Cluster of Differentiation; CM refers to central memory; EM refers to effector memory, TIGIT refers to T cell immunoreceptor with Ig and ITIM domains.

Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel

Myeloid panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80. In below table HLA refers to Human Leukocyte Antigen; MDSC refers to myeloid-derived suppressor cell; DC refers to Dendritic cells; MYDC refers to Myeloid Dendritic Cells; IMMYE_MDSC refers to Immature myeloid cells & a subset of myeloid suppressor cells within the CD14-HLA class II- myeloid cell population.

Autoantibodies Against Glutamic Acid Decarboxylase (GAD)

Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive.

Autoantibodies Against Zinc-transporter 8 (ZnT8)

Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive.

Autoantibodies Against Islet Antigen-2 (IA2)

Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.

Autoantibodies Against Insulin Autoantibodies (IAA)

Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.

Change in Biomarker: Total Interleukin-21 (IL-21)

IL-21 is evaluated at baseline (week 0), week 54 and week 80.

Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)

Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.

Change in Short Form 36 Health Survey (SF-36)

SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline.

Change in Experience of Treatment Benefits and Barriers (ETBB)

Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier.

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction.

Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L).

AUC0-2h of C-peptide at Week 80 Relative to Baseline

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.

Cmax of C-peptide at Week 80 Relative to Baseline

Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).

AUC0-4h of Glucose at Week 80 Relative to Baseline

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L).

AUC0-2h of Glucose at Week 80 Relative to Baseline

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol*h/L'.

Cmax of Glucose at Week 80 Relative to Baseline

Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.

Full Information

NCT ID

NCT02443155

First Posted

May 11, 2015

Last Updated

March 10, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02443155

Brief Title

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Official Title

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 10, 2015 (Actual)

Primary Completion Date

August 31, 2018 (Actual)

Study Completion Date

February 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

308 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC0114-0006 + Liraglutide

Arm Type

Experimental

Arm Title

NNC0114-0006 + Placebo

Arm Type

Experimental

Arm Title

Liraglutide + Placebo

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC0114-0006

Intervention Description

NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment

Primary Outcome Measure Information:

Title

Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline

Description

Time Frame

0 - 4 hours post-dose on week 0 and week 54

Secondary Outcome Measure Information:

Title

AUC0-2h of C-peptide at Week 54 Relative to Baseline

Description

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.

Time Frame

0-2 hours post-dose on week 0 and week 54

Title

Cmax of C-peptide at Week 54 Relative to Baseline

Description

Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).

Time Frame

0-4 hours post-dose on week 0 and week 54

Title

AUC0-4h of Glucose at Week 54 Relative to Baseline

Description

Time Frame

0 - 4 hours post-dose on week 0 and week 54

Title

AUC0-2h of Glucose at Week 54 Relative to Baseline

Description

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol*h/L'.

Time Frame

0-2 hours post-dose on week 0 and week 54

Title

Cmax of Glucose at Week 54 Relative to Baseline

Description

Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.

Time Frame

0-4 hours post-dose on week 0 and week 54

Title

Number of Treatment Emergent Adverse Events

Description

Time Frame

Week 0-54; Week 54-80

Title

Number of Treatment Emergent Hyperglycaemic Episodes

Description

Time Frame

Week 0-54; Week 54-80

Title

Number of Treatment Emergent Episodes of Diabetic Ketoacidosis

Description

Time Frame

Weeks 0-54; Weeks 54-80

Title

Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion

Description

Time Frame

Week 0-54

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)

Description

Time Frame

Weeks 0-54; Weeks 54-80

Title

Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions

Description

Time Frame

Weeks 0-54; Weeks 54-80

Title

Change in Body Weight (kg)

Description

Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Diabetes Retinopathy

Description

Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.

Time Frame

Baseline, week 54 and week 80

Title

Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline

Description

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Erythrocytes

Description

Change in erythrocytes (measured in 10^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Haematocrit

Description

Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Haemoglobin

Description

Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Leukocytes

Description

Change in leukocytes (measured in 10^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Mean Corpuscular Hemoglobin

Description

Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Mean Corpuscular Hemoglobin Concentration

Description

Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Mean Corpuscular Volume

Description

Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Thrombocytes

Description

Change in thrombocytes (measured in 10^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Eosinophil

Description

Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Neutrophils

Description

Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Basophils

Description

Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Lymphocytes

Description

Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Haematology: Monocytes

Description

Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Alanine Aminotransferase (ALAT)

Description

Change in ALAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Albumin

Description

Change in albumin (measured in gram per deciliter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Amylase

Description

Change in amylase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Alkaline Phosphatase (ALP)

Description

Change in ALP (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Aspartate Aminotransferase (ASAT)

Description

Change in ASAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Total Bilirubin

Description

Change in Total bilirubin (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Calcium Corrected

Description

Change in calcium corrected (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Chloride

Description

Change in chloride (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Creatine Kinase

Description

Change in creatine kinase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Creatinine

Description

Change in creatinine (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Gamma-glutamyl Transferase (GGT)

Description

Change in GGT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: C-reactive Protein Serum

Description

Change in C-reactive protein serum (measured in milligrams per liter [mg/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Lactate Dehydrogenase

Description

Change in Lactate Dehydrogenase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Lipase

Description

Change in lipase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Magnesium

Description

Change in magnesium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Phosphate

Description

Change in phosphate (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Potassium

Description

Change in potassium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Sodium

Description

Change in sodium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Total Protein

Description

Change in total protein (measured in gram per liter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Blood Urea Nitrogen Serum

Description

Change in blood urea nitrogen serum (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Biochemistry: Uric Acid

Description

Change in Uric Acid (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in International Normalised Ratio (INR)

Description

Change in INR (measured in ratio]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in D-Dimer

Description

Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Lipids: Total Cholesterol (Ratio to Baseline)

Description

Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Lipids: Free Fatty Acids (Ratio to Baseline)

Description

Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Lipids: HDL Cholesterol (Ratio to Baseline)

Description

Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Lipids: LDL Cholesterol (Ratio to Baseline)

Description

Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Lipids: Triglycerides (TG) (Ratio to Baseline)

Description

Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Total Immunoglobulin E (IgE)

Description

Change in IgE (measured in kilo international units per liter [kIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Urinalysis: Urine Dipsticks

Description

Time Frame

Week 0, week 54 and week 80

Title

Change in Cytokines: Interleukin (IL)-6

Description

IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Time Frame

Week 0, week 54 and week 80

Title

Change in Cytokines- Interleukin (IL)-10

Description

IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Time Frame

Week 0, week 54 and week 80

Title

Change in Cytokines: Interleukin (IL)-17

Description

IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Time Frame

Week 0, week 54 and week 80

Title

Change in Cytokines: Interferon (IFN) Gamma

Description

IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Time Frame

Week 0, week 54 and week 80

Title

Change in Cytokines: TNF-alpha

Description

TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Time Frame

Week 0, week 54 and week 80

Title

Change in Hormone Level: Thyroid Stimulating Hormone (TSH)

Description

Change in TSH (measured in milli international units per liter [mIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Hormone Level: Calcitonin

Description

Change in Calcitonin (measured in nanogram per liter [ng/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Systolic and Diastolic Blood Pressure

Description

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Pulse

Description

Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Body Temperature

Description

Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.

Time Frame

Week 0, week 54) and (week 0, week 80)

Title

Change in Respiratory Rate

Description

Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Electrocardiogram (ECG)

Description

Time Frame

Week 0, week 54 and week 80

Title

Change in Eye-examination

Description

Time Frame

Week 0, week 54 and week 80

Title

Change in Physical Examination

Description

Time Frame

Week 0, week 54 and week 80

Title

Occurrence of Anti-NNC0114-0006 Antibodies

Description

Time Frame

Week 0, week 54 and week 80

Title

Occurrence of Anti-liraglutide Antibodies

Description

Time Frame

Week 0, week 54 and week 80

Title

Change in Insulin Dose

Description

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Number of Insulin Injections

Description

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Number of Weeks Off Bolus Insulin

Description

The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.

Time Frame

(Week 0 to week 54) and (week 0 to week 80)

Title

Change in HbA1c

Description

Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Fasting Plasma Glucose

Description

Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Fasting C-peptide- Ratio to Baseline

Description

Change in fasting C-peptide (measured in nanomole per liter [nmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Fasting Glucagon- Ratio to Baseline

Description

Change in fasting glucagon (measured in picogram per milliliter [pg/mL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

7-point SMPG Profiles

Description

Time Frame

Week 54 and Week 80

Title

Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner

Description

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)

Description

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Mean of 7-point Profiles

Description

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)

Description

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.

Time Frame

Week 54 and week 80

Title

Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)

Description

Time Frame

Pre-dose and 1 hour post-dose during week 48 to week 54

Title

Terminal Half-life (t½) After Last Dose of NNC0114-0006

Description

Time Frame

Pre-dose and 1 hour post-dose during week 48 to week 80

Title

Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)

Description

Time Frame

Pre-dose and 1 hour post-dose during week 48 to week 80

Title

Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)

Description

Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Time Frame

Pre-dose and 1 hour post-dose during week 48 to week 54

Title

Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)

Description

This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.

Time Frame

Pre-dose and 1 hour post-dose during week 48 to week 80

Title

Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)

Description

Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Time Frame

Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)

Title

Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)

Description

Time Frame

Week 48 (predose)

Title

Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)

Description

Time Frame

Week 48 (1 hour post-dose)

Title

Liraglutide Concentration at Steady State (C Liraglutide)

Description

C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.

Time Frame

Week 54 (post-dose)

Title

Change in Biomarker: Immune Phenotyping- B Cell Panel

Description

Time Frame

Week 0, week 54 and week 80

Title

Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel

Description

Time Frame

Week 0, week 54 and week 80

Title

Change in Biomarker: Immune Phenotyping- T Cell Panel

Description

Time Frame

Week 0, week 54 and week 80

Title

Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel

Description

Time Frame

Week 0, week 54 and week 80

Title

Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel

Description

Time Frame

Week 0, week 54 and week 80

Title

Autoantibodies Against Glutamic Acid Decarboxylase (GAD)

Description

Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive.

Time Frame

Week 0, week 54 and week 80

Title

Autoantibodies Against Zinc-transporter 8 (ZnT8)

Description

Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive.

Time Frame

Week 0, week 54 and week 80

Title

Autoantibodies Against Islet Antigen-2 (IA2)

Description

Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.

Time Frame

Week 0, week 54 and week 80

Title

Autoantibodies Against Insulin Autoantibodies (IAA)

Description

Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.

Time Frame

Week 0, week 54 and week 80

Title

Change in Biomarker: Total Interleukin-21 (IL-21)

Description

IL-21 is evaluated at baseline (week 0), week 54 and week 80.

Time Frame

Week 0, week 54 and week 80

Title

Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)

Description

Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.

Time Frame

Week 0, week 54 and week 80

Title

Change in Short Form 36 Health Survey (SF-36)

Description

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Experience of Treatment Benefits and Barriers (ETBB)

Description

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Description

Time Frame

(Week 0, week 54) and (week 0, week 80)

Title

Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline

Description

Time Frame

0 - 4 hours post-dose on week 0 and week 80

Title

AUC0-2h of C-peptide at Week 80 Relative to Baseline

Description

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.

Time Frame

0-2 hours post-dose on week 0 and week 80

Title

Cmax of C-peptide at Week 80 Relative to Baseline

Description

Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).

Time Frame

0-4 hours post-dose on week 0 and week 80

Title

AUC0-4h of Glucose at Week 80 Relative to Baseline

Description

Time Frame

0 - 4 hours post-dose on week 0 and week 80

Title

AUC0-2h of Glucose at Week 80 Relative to Baseline

Description

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol*h/L'.

Time Frame

0-2 hours post-dose on week 0 and week 80

Title

Cmax of Glucose at Week 80 Relative to Baseline

Description

Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.

Time Frame

0-4 hours post-dose on week 0 and week 80

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2 BMI (body mass index) higher or equal to 18.5 kg/m^2 Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening Insulin dependence unless in temporary spontaneous remission (honeymoon period) Exclusion Criteria: Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII) History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis) History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy Vaccination within 4 weeks before randomisation, Visit 3 (V3) Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1) History of pancreatitis (acute or chronic) Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC) Any past or current diagnosis of malignant neoplasms Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77079

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75149

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2E1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7T 2P5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3T2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

State/Province

Quebec

ZIP/Postal Code

G1L 3L5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Esbjerg

ZIP/Postal Code

6700

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 15

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 4

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Galway

ZIP/Postal Code

H91 YR71

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah Tikva

ZIP/Postal Code

49202

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Oslo

ZIP/Postal Code

0586

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Stavanger

ZIP/Postal Code

4011

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Gdansk

ZIP/Postal Code

80-214

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

04-736

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Almada

ZIP/Postal Code

2805-267

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Amadora

ZIP/Postal Code

2720-276

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Matosinhos

ZIP/Postal Code

4464-513

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Viana do Castelo

ZIP/Postal Code

4901-858

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Arkhangelsk

ZIP/Postal Code

163001

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Dzerzhinskiy

ZIP/Postal Code

140091

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

123423

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125315

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

199226

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410031

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Syktyvkar

ZIP/Postal Code

167981

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Ulianovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Yoshkar-Ola

ZIP/Postal Code

424004

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41003

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Karlstad

ZIP/Postal Code

651 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

02232

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

04053

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Vinnytsia

ZIP/Postal Code

21010

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Blackburn

ZIP/Postal Code

BB2 3HH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Chester

ZIP/Postal Code

CH2 1UL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Edgbaston, Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

E1 2AT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Newcastle upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Plymouth

ZIP/Postal Code

PL8 8DQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Sheffield

ZIP/Postal Code

S5 7AU

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Stevenage

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Swansea

ZIP/Postal Code

SA2 8PP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33662334

Citation

von Herrath M, Bain SC, Bode B, Clausen JO, Coppieters K, Gaysina L, Gumprecht J, Hansen TK, Mathieu C, Morales C, Mosenzon O, Segel S, Tsoukas G, Pieber TR; Anti-IL-21-liraglutide Study Group investigators and contributors. Anti-interleukin-21 antibody and liraglutide for the preservation of beta-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2021 Apr;9(4):212-224. doi: 10.1016/S2213-8587(21)00019-X. Epub 2021 Mar 1.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

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A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Diabetes, Diabetes Mellitus, Type 1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial