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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511692
• Other study ID #: NN2211-1589
• Secondary ID: 2006-000377-30
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2012
• Last updated: January 24, 2017
• Start date: November 2005
• Est. completion date: September 2007

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
1.8 mg/day injected subcutaneously for 4 weeks
• placebo
Liraglutide placebo, injected subcutaneously for 4 weeks
• placebo
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
• glimepiride
Dose individually adjusted, administered orally for 4 weeks

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Adelaide	South Australia
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Germany, 

References & Publications (1)

Horowitz M, Flint A, Jones KL, Hindsberger C, Rasmussen MF, Kapitza C, Doran S, Jax T, Zdravkovic M, Chapman IM. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabet — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Secondary	The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Secondary	Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Secondary	Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Secondary	Total duration of eating at the buffet meal (satiation)
Secondary	Weight
Secondary	Waist circumference
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk