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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01508949
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2001
Actual Primary Completion Date : March 2002
Actual Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: NNC 90-1170 Drug: liraglutide
Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
Other Name: NNC 90-1170

Placebo Comparator: Placebo Drug: placebo
Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously

Primary Outcome Measures :
  1. Change in weight

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01508949

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Novo Nordisk Investigational Site
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S Identifier: NCT01508949     History of Changes
Other Study ID Numbers: NN2211-1333
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists