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
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: NNC 90-1170
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in weight [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 35
Study Start Date: June 2001
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170 Drug: NNC 90-1170
Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
Placebo Comparator: Placebo Drug: placebo
Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years and older
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508949

Locations
Denmark
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01508949     History of Changes
Other Study ID Numbers: NN2211-1333
Study First Received: January 9, 2012
Last Updated: January 9, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 14, 2014