Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes
Phase 4
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00948168
- Lead Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improvement in HbA1c 6 months
- Secondary Outcome Measures
Name Time Method Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity 6 months
Trial Locations
- Locations (1)
Cliniques universitaires St-Luc
🇧🇪Brussels, Brabant, Belgium