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Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01511692
First received: January 12, 2012
Last updated: August 30, 2012
Last verified: January 2012

January 12, 2012
August 30, 2012
November 2005
September 2007   (final data collection date for primary outcome measure)
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01511692 on ClinicalTrials.gov Archive Site
  • The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 [ Designated as safety issue: No ]
  • Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10 [ Designated as safety issue: No ]
  • Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10 [ Designated as safety issue: No ]
  • Total duration of eating at the buffet meal (satiation) [ Designated as safety issue: No ]
  • Weight [ Designated as safety issue: No ]
  • Waist circumference [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo

This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: liraglutide
    1.8 mg/day injected subcutaneously for 4 weeks
  • Drug: placebo
    Liraglutide placebo, injected subcutaneously for 4 weeks
  • Drug: placebo
    Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
  • Drug: glimepiride
    Dose individually adjusted, administered orally for 4 weeks
  • Experimental: Lira --> placebo
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
  • Placebo Comparator: Placebo --> glim
    Interventions:
    • Drug: placebo
    • Drug: glimepiride
  • Active Comparator: Glim --> lira
    Interventions:
    • Drug: liraglutide
    • Drug: glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy
  • HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)
  • Body mass index (BMI) between 27-40 kg/m^2 (both inclusive)
  • Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
  • Euthyroid subjects
  • Subjects should be unrestrained eaters

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Impaired liver function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Known or suspected allergy to trial products or related products
  • Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight
  • Active hepatitis B and/or active hepatitis C
  • Positive HIV (human immunodeficiency virus) antibodies
  • Known or suspected abuse of alcohol or narcotics
  • Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany
 
NCT01511692
NN2211-1589, 2006-000377-30
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