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Liraglutide as add-on to Insulin in Type 1 Diabetes (T1DMLIRA)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Liraglutide

Placebo

Liraglutide

Placebo

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Cognitive performance, Hypoglycemia, Insulin, Glucagon-Like Peptide 1, Hypoglycemic Agents, Physiological Effects of Drugs, Pharmacologic Actions, Incretins, Hormones

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18-70 years
BMI: 18-28
HbA1c ≥ 8 %
No residual β-cell function (glucagon test with c-peptide < 60 pM)
Caucasian
Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).
Remission phase must be completed
Female participants must use adequate contraception
Informed consent

Exclusion Criteria:

Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria.
Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).
Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l
Pregnancy or lactation
Epilepsy
Use of antiepileptic medication
Use of beta blockers
Previously apoplexy cerebri.
Any use of benzodiazepine within the last month
Any use of neuroleptic drugs within the last six months
Self-perceived hearing loss
Alcohol or drug abuse
Allergy to the medication or placebo.
Treatment with any medication affecting glucose metabolism.
Any disorder which in the investigators opinion could interfere with the safety and results of the trial

Sites / Locations

Dept. of Endocrinology, Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Placebo + Insulin + Study 2

Liraglutide + Insulin + Study 2

Liraglutide + Insulin + Study 1

Placebo + Insulin + Study 1

Arm Description

Study 2: Cognitive performance test

Study 1: Gastric emptying test

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c (glycosylated haemoglobin)

Changes from baseline in EEG and cognitive performances

Change from baseline in gastric emptying rate

Secondary Outcome Measures

Change from baseline in glycemic control (CGM)

Change from baseline in total daily insulin dose

Changes from baseline in the counterregulatory hormone responses during hypoglycemia

Change from baseline in body weight

Change from baseline in auditory evoked potentials (AEP) during hypoglycemia

Change from baseline in corrected QTc-interval (QTc) during hypoglycemia

Change from baseline in hypoglycemic symptom score

Full Information

NCT ID

NCT02092896

First Posted

March 18, 2014

Last Updated

March 31, 2015

Sponsor

Hvidovre University Hospital

Collaborators

NNF Center for Basal Metabolic Research, Denmark, Hillerod Hospital, Denmark, Danish PhD schools of Molecular Metabolism and Endocrinology, Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02092896

Brief Title

Liraglutide as add-on to Insulin in Type 1 Diabetes

Acronym

T1DMLIRA

Official Title

Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

Collaborators

NNF Center for Basal Metabolic Research, Denmark, Hillerod Hospital, Denmark, Danish PhD schools of Molecular Metabolism and Endocrinology, Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.

6. Conditions and Keywords

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

Diabetes, Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Cognitive performance, Hypoglycemia, Insulin, Glucagon-Like Peptide 1, Hypoglycemic Agents, Physiological Effects of Drugs, Pharmacologic Actions, Incretins, Hormones

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo + Insulin + Study 2

Arm Type

Placebo Comparator

Arm Description

Study 2: Cognitive performance test

Arm Title

Liraglutide + Insulin + Study 2

Arm Type

Experimental

Arm Description

Study 2: Cognitive performance test

Arm Title

Liraglutide + Insulin + Study 1

Arm Type

Experimental

Arm Description

Study 1: Gastric emptying test

Arm Title

Placebo + Insulin + Study 1

Arm Type

Placebo Comparator

Arm Description

Study 1: Gastric emptying test

Intervention Type

Drug

Intervention Name(s)

Liraglutide

Intervention Description

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.

Intervention Type

Drug

Intervention Name(s)

Liraglutide

Intervention Description

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.

Primary Outcome Measure Information:

Title

Change from baseline in HbA1c (glycosylated haemoglobin)

Time Frame

Week 0, week 12

Title

Changes from baseline in EEG and cognitive performances

Time Frame

week 0, week 12

Title

Change from baseline in gastric emptying rate

Time Frame

week 0, week 12

Secondary Outcome Measure Information:

Title

Change from baseline in glycemic control (CGM)

Time Frame

week 0, week 12

Title

Change from baseline in total daily insulin dose

Time Frame

week 0, week 12

Title

Changes from baseline in the counterregulatory hormone responses during hypoglycemia

Time Frame

week 0, week 12

Title

Change from baseline in body weight

Time Frame

week 0, week 12

Title

Change from baseline in auditory evoked potentials (AEP) during hypoglycemia

Time Frame

week 0, week 12

Title

Change from baseline in corrected QTc-interval (QTc) during hypoglycemia

Time Frame

week 0, week 12

Title

Change from baseline in hypoglycemic symptom score

Time Frame

week 0, week 12

Other Pre-specified Outcome Measures:

Title

Frequency of Hypoglycemic episodes

Time Frame

Week 0, week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18-70 years BMI: 18-28 HbA1c ≥ 8 % No residual β-cell function (glucagon test with c-peptide < 60 pM) Caucasian Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive). Remission phase must be completed Female participants must use adequate contraception Informed consent Exclusion Criteria: Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria. Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH). Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l Pregnancy or lactation Epilepsy Use of antiepileptic medication Use of beta blockers Previously apoplexy cerebri. Any use of benzodiazepine within the last month Any use of neuroleptic drugs within the last six months Self-perceived hearing loss Alcohol or drug abuse Allergy to the medication or placebo. Treatment with any medication affecting glucose metabolism. Any disorder which in the investigators opinion could interfere with the safety and results of the trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian SS Frandsen, MD

Organizational Affiliation

Hvidovre University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of Endocrinology, Hvidovre University Hospital

City

Hvidovre

State/Province

Copenhagen

ZIP/Postal Code

2650

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

26486191

Citation

Frandsen CS, Dejgaard TF, Holst JJ, Andersen HU, Thorsteinsson B, Madsbad S. Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blind Parallel Study. Diabetes Care. 2015 Dec;38(12):2250-7. doi: 10.2337/dc15-1037. Epub 2015 Oct 20.

Results Reference

derived

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Liraglutide as add-on to Insulin in Type 1 Diabetes

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