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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01508949

Enrollment

Registered

2012-01-12

Start date

2001-06-30

Completion date

2002-03-31

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGliraglutide

Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously

DRUGplacebo

Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in weight	—

Secondary

Measure	Time frame
HbA1c (Glycosylated Haemoglobin)	—
Adverse events	—
Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan)	—
Energy expenditure	—
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	—
Waist circumference	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026