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A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus (DUALTM IX)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin degludec/liraglutide
insulin glargine
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% [53-97 mmol/mol] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m^2 and below 40 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IDegLira

IGlar

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c (Glycosylated Haemoglobin)
The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.

Secondary Outcome Measures

Change in Body Weight
The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values <3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia.
Insulin Dose, Total Daily Dose (U)
Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.
Number of Treatment-emergent Adverse Events
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Responder (Yes/No) for HbA1c Below 7.0%
The proportion of subjects achieving pre-defined HbA1c targets <7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Change From Baseline After 26 Weeks in Waist Circumference
Mean change from baseline in waist circumference after 26 weeks of randomised treatment.
Change From Baseline in Fasting Lipid Profile: Cholesterol
The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Change From Baseline in Fasting Lipid Profile: Triglycerides
The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.
Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here.
Change From Baseline in Systolic Blood Pressure
Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment.
Change From Baseline in Diastolic Blood Pressure
Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment.
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment.
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG >3.9 mmol/L with symptoms. 6) Unclassifiable.
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment.
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here.
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
The patient reported outcomes are calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D domain scores and the total scores are later transformed to a 0-100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here.

Full Information

First Posted
May 13, 2016
Last Updated
August 10, 2020
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02773368
Brief Title
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus
Acronym
DUALTM IX
Official Title
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus. DUALTM IX - Add-on to SGLT2i
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
September 26, 2017 (Actual)
Study Completion Date
October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 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 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDegLira
Arm Type
Experimental
Arm Title
IGlar
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec/liraglutide
Intervention Description
IDegLira will be given subcutaneously ( s.c., under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
IGlar will be given subcutaneously ( s.c., under the skin) once daily.
Primary Outcome Measure Information:
Title
Change in HbA1c (Glycosylated Haemoglobin)
Description
The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
Week 0, Week 26
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
Week 0, Week 26
Title
Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
Description
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values <3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia.
Time Frame
Week 0-26
Title
Insulin Dose, Total Daily Dose (U)
Description
Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Change in Fasting Plasma Glucose (FPG)
Description
Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.
Time Frame
Week 0, Week 26
Title
Number of Treatment-emergent Adverse Events
Description
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Time Frame
Week 0-26
Title
Responder (Yes/No) for HbA1c Below 7.0%
Description
The proportion of subjects achieving pre-defined HbA1c targets <7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
Description
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
Description
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
Description
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
Description
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
Description
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
Description
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
Description
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time Frame
After 26 weeks
Title
Change From Baseline After 26 Weeks in Waist Circumference
Description
Mean change from baseline in waist circumference after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in Fasting Lipid Profile: Cholesterol
Description
The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
Description
The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
Description
The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
Description
The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in Fasting Lipid Profile: Triglycerides
Description
The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
Description
The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
Description
Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Time Frame
After 26 weeks
Title
Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
Description
Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Time Frame
After 26 weeks
Title
Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
Description
Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here.
Time Frame
After 26 weeks
Title
Change From Baseline in Systolic Blood Pressure
Description
Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in Diastolic Blood Pressure
Description
Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
Description
Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment.
Time Frame
Week 0-26
Title
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
Description
American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG >3.9 mmol/L with symptoms. 6) Unclassifiable.
Time Frame
Week 0-26
Title
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
Description
Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
Time Frame
After 26 weeks
Title
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
Description
Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
Time Frame
After 26 weeks
Title
Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
Description
Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment.
Time Frame
After 26 weeks
Title
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
Description
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here.
Time Frame
After 26 weeks
Title
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
Description
The patient reported outcomes are calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D domain scores and the total scores are later transformed to a 0-100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here.
Time Frame
After 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% [53-97 mmol/mol] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m^2 and below 40 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products
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
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
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
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
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
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118
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
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Whiteville
State/Province
North Carolina
ZIP/Postal Code
28472
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040-6815
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620-7352
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228-3419
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 4W3
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2M1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Smiths Falls
State/Province
Ontario
ZIP/Postal Code
K7A 4W8
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
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Lahti
ZIP/Postal Code
15110
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
FI-90220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Rovaniemi
ZIP/Postal Code
96400
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1042
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Komarom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Salgótarján
ZIP/Postal Code
3100
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Hyderbad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bhopal
State/Province
Madhya Pradesh
ZIP/Postal Code
462037
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411040
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221105
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Barnaul
ZIP/Postal Code
656043
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
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petesburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Celje
ZIP/Postal Code
SI-3000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Koper
ZIP/Postal Code
SI-6000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Kranj
ZIP/Postal Code
4000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Murska Sobota
ZIP/Postal Code
SI-9000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Trbovlje
ZIP/Postal Code
1420
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Almería
ZIP/Postal Code
04001
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Antequera
ZIP/Postal Code
29200
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Boadilla del Monte
ZIP/Postal Code
28660
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
Villamartin
ZIP/Postal Code
11650
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Baden
ZIP/Postal Code
5400
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Genève 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Luzern 16
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Schaffhausen
ZIP/Postal Code
8208
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Winterthur
ZIP/Postal Code
8400
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Zollikerberg
ZIP/Postal Code
8125
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30761720
Citation
Philis-Tsimikas A, Billings LK, Busch R, Portillo CM, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2019 Jun;21(6):1399-1408. doi: 10.1111/dom.13666. Epub 2019 Apr 4.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus

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