Diabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGglimepiride
Dose individually adjusted, administered orally for 4 weeks
DRUGliraglutide
1.8 mg/day injected subcutaneously for 4 weeks
DRUGplacebo
Liraglutide placebo, injected subcutaneously for 4 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
| The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 | — |
| Waist circumference | — |
| Adverse events | — |
| Weight | — |
Countries
Australia, Germany
Outcome results
None listed