Effect of Liraglutide on Weight and Appetite in Obese Subjects With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: placebo; Drug: liraglutide

• Registration Number: NCT01508949
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2002-03
• Study Completion: 2002-03
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Type 2 diabetes mellitus
• Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide
• HbA1c for diet treated subjects 6.5-12%, both inclusive
• HbA1c for sulphonylurea or repaglinide treated subjects maximum 10%
• Body mass index (BMI) at least 27 kg/m^2
• Euthyroid subjects
• Fasting blood glucose 7-14 mmol/l

Exclusion Criteria

• Impaired liver function
• Impaired renal function
• Cardiac problems
• Uncontrolled treated/untreated hypertension
• Recurrent severe hypoglycaemia as judged by the Investigator
• Known or suspected allergy to trial product or related products
• Use of any drug (except for OHAs (oral hypoglycaemic agents), which in the Investigator's opinion could interfere with the glucose level or body weight. Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC 90-1170	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Change in weight

Secondary Outcome Measures

Name	Time	Method
Energy expenditure
HbA1c (Glycosylated Haemoglobin)
Adverse events
Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan)
Waist circumference
Spontaneous energy intake assessed in connection to the ad libitum lunch meal
Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale))
Gastric emptying rate

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Frederiksberg C, Denmark