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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: glimepiride; Drug: placebo; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511692

2006-000377-30 (EudraCT Number)

NN2211-1589

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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43 participants in 3 patient groups, including a placebo group

Lira --> placebo

Experimental group

Treatment:

Drug: placebo

Drug: placebo

Drug: liraglutide

Placebo --> glim

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: glimepiride

Glim --> lira

Active Comparator group

Treatment:

Drug: glimepiride

Drug: liraglutide