Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.

Official Title
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A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo
* Drug: placebo
* Drug: glimepiride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive) Body mass index (BMI) between 27-40 kg/m^2 (both inclusive) Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight) Euthyroid subjects Subjects should be unrestrained eaters Exclusion Criteria: Recurrent severe hypoglycaemia Impaired liver function Impaired renal function Cardiac problems Uncontrolled treated/untreated hypertension Known or suspected allergy to trial products or related products Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight Active hepatitis B and/or active hepatitis C Positive HIV (human immunodeficiency virus) antibodies Known or suspected abuse of alcohol or narcotics Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Lira --> placebo<br> | Drug: liraglutide<br>* 1.8 mg/day injected subcutaneously for 4 weeks<br>Drug: placebo<br>* Liraglutide placebo, injected subcutaneously for 4 weeks<br>|
| Placebo Comparator: Placebo --> glim<br> | Drug: placebo<br>* Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks<br>Drug: glimepiride<br>* Dose individually adjusted, administered orally for 4 weeks<br>|
| Active Comparator: Glim --> lira<br> | Drug: liraglutide<br>* 1.8 mg/day injected subcutaneously for 4 weeks<br>Drug: glimepiride<br>* Dose individually adjusted, administered orally for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 |  |  | 
| Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10 |  |  | 
| Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 |  |  | 
| Total duration of eating at the buffet meal (satiation) |  |  | 
| Weight |  |  | 
| Waist circumference |  |  | 
| Adverse events |  |  |