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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Glimepiride; Liraglutide

Criteria

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