Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01511692
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lira --> placebo liraglutide - Lira --> placebo placebo - Placebo --> glim placebo - Glim --> lira glimepiride - Placebo --> glim glimepiride - Glim --> lira liraglutide -
- Primary Outcome Measures
Name Time Method The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
- Secondary Outcome Measures
Name Time Method Waist circumference The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 Adverse events Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10 Total duration of eating at the buffet meal (satiation) Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 Weight
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany