Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00948168
First received: July 27, 2009
Last updated: July 30, 2009
Last verified: July 2009

July 27, 2009
July 30, 2009
July 2008
July 2009   (final data collection date for primary outcome measure)
Improvement in HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00948168 on ClinicalTrials.gov Archive Site
Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes
6-Months Exenatide and Glucose Homeostasis Determinants in Type 2 Diabetic Patients

The purpose of this study is to determine in type 2 diabetic patients in secondary failure to combined oral therapy whether, besides improvement in glycemic control, addition of exenatide, a new drug introduced to treat diabetes before addition of insulin to current therapy, over 6 months is associated with improvement in beta-cell function, insulin sensitivity following 24-hours discontinuation of the drug.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: exenatide (Byetta)
all patients receive 5 then 10 µg exenatide subcutaneously BID for 6 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetes subjects
  • 40 to 80 years
  • body mass index (BMI) between 25 and 40 kg/m²
  • baseline glycated haemoglobin (HbA1c) > 7.0 %, despite a maximally-tolerated combined oral therapy with a BCF stimulant (sulfonylurea or repaglinide) plus metformin

Exclusion Criteria:

  • previous or current use of glitazone
  • previous use of systemic glucocorticoids, weight-reducing drug(s) such as sibutramine
  • previous exposure to GLP-1 receptor agonist or DPP-4 inhibitors
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00948168
UCL-DIAB-01
No
Service d'Endocrinologie et Nutrition, Cliniques universitaires St-Luc, Brussels
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Not Provided
Not Provided
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
July 2009

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