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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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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 May 23, 2013