A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes
- Registration Number
- NCT00260156
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- Not currently on drug therapy for type 2 diabetes
- Blood glucose criteria must be met
Exclusion Criteria
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Serious cardiovascular events within the past 6 months
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vildagliptin vildagliptin - Placebo placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks 52 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in disposition index at 52 weeks 52 weeks Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks 52 weeks Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks 52 weeks Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks 52 weeks Beta-cell function parameter derived from standard meal challenge 52 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇨🇭Basel, Switzerland