Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01508949
First received: January 9, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted

January 9, 2012
January 9, 2012
June 2001
March 2002   (final data collection date for primary outcome measure)
Change in weight [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Total fat mass (assessed by use of DEXA (dual energy X-ray absortiometry) scan) [ Designated as safety issue: No ]
  • Waist circumference [ Designated as safety issue: No ]
  • Spontaneous energy intake assessed in connection to the ad libitum lunch meal [ Designated as safety issue: No ]
  • Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale)) [ Designated as safety issue: No ]
  • Gastric emptying rate [ Designated as safety issue: No ]
  • Energy expenditure [ Designated as safety issue: No ]
  • HbA1c (Glycosylated Haemoglobin) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: NNC 90-1170
    Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
  • Drug: placebo
    Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
  • Experimental: NNC 90-1170
    Intervention: Drug: NNC 90-1170
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
March 2002
March 2002   (final data collection date for primary outcome measure)

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
Not Provided
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01508949
NN2211-1333
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
Novo Nordisk A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP