A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00351585
- Lead Sponsor
- Novartis
- Brief Summary
Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
- Diagnosed with type 2 diabetes for at least 6 months
- Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
- BMI in the range 22-45
- Blood glucose criteria must be met
Exclusion Criteria
- Pregnancy or lactation
- Type 1 diabetes or diabetes resulting from pancreatic injury
- Cardiovascular complications as defined by the protocol
- Significant diabetic complications as defined by the protocol
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in maximal insulin secretory capacity at 12 weeks Durability of this effect after a 2-week washout
- Secondary Outcome Measures
Name Time Method Change from baseline in beta-cell sensitivity to glucose at 12 weeks Durability of this effect after a 2-week washout Chance from baseline in glucagon secretion at 12 weeks