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Completed

NCT Number: NCT01508949

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site

Frederiksberg C, 1958, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Other names: NNC 90-1170

Placebo

Drug

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

Primary outcomes

  1. Change in weight

Secondary outcomes

  1. Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan)

  2. Waist circumference

  3. Spontaneous energy intake assessed in connection to the ad libitum lunch meal

  4. Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale))

  5. Gastric emptying rate

  6. Energy expenditure

  7. HbA1c (Glycosylated Haemoglobin)

  8. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jan 12, 2012
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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