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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 9, 2012
Last updated: March 25, 2015
Last verified: March 2015
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 Mellitus, Type 2
Drug: liraglutide
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 absorptiometry) 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: 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01508949

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01508949     History of Changes
Other Study ID Numbers: NN2211-1333 
Study First Received: January 9, 2012
Last Updated: March 25, 2015
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
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 processed this record on January 14, 2017