The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment with liraglutide or placebo. Subjects will initially be randomised to one of the three dose groups, and subsequently randomly allocated to one of two treatment sequences (liraglutide/placebo or placebo/liraglutide).

Official Title
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The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to randomisation Body mass index (BMI) between 20.0 and 28.0 kg/m^2 (both inclusive) Exclusion Criteria: Use of liraglutide or exenatide within 3 months of randomisation Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the trial physician or hospitalisation for diabetic ketoacidosis during the previous 6 months Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low<br> | Drug: liraglutide<br>* Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.<br>|
| Experimental: Medium<br> | Drug: liraglutide<br>* Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.<br>|
| Experimental: High<br> | Drug: liraglutide<br>* Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) ) |  | At week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean glucagon concentration at plasma glucose levels other than nadir |  | At week 4 | 
| Geometric mean concentrations of adrenaline and noradrenaline at nadir |  | At week 4 | 
| Time from termination of insulin infusion at nadir to reach plasma glucose 4.0 |  | At week 4 |