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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

NNC 90-1170 Mechanism of Action: A Single-centre, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial Evaluating the Effect of NNC 90-1170 on Weight and Appetite in Obese Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508949
• Other study ID #: NN2211-1333
• Status: Completed
• Phase: Phase 2
• Start date: June 2001
• Est. completion date: March 2002

Study information

• Verified date: October 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
• placebo
Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Harder H, Nielsen L, Tu DT, Astrup A. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1915-21. — View Citation

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk