A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00351546
- Lead Sponsor
- Novartis
- Brief Summary
Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Diagnosed with type 2 diabetes at least 3 months prior to screening
- Blood glucose criteria must be met
- On stable dose of metformin therapy
- BMI less than or equal to 39
Exclusion Criteria
- Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
- Treatment with thiazolidinediones or use of insulin within the previous 3 months
- Significant illness within 2 weeks prior to dosing
- High fasting triglycerides as defined by the protocol
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Effect on insulin sensitivity at 6 weeks
- Secondary Outcome Measures
Name Time Method Lipolysis rate after 6 weeks of treatment Glucose disposal after 6 weeks of treatment Gluconeogenesis rate after 6 weeks of treatment Plasma free fatty acid concentration after 6 weeks of treatment Hepatic glucose production after 6 weeks of treatment