A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes
Phase 2
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00099957
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study was not conducted in the United States. Many people with type 2 diabetes also have high cholesterol levels. The purpose of this study was to evaluate the effects of vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and cholesterol in people with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
- Blood glucose criteria must be met
- Genetic markers associated with increased risk of cardiovascular disease
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 25-40
Exclusion Criteria
- Pregnancy or lactation
- Type 1 diabetes
- High cholesterol as defined by the protocol
- Evidence of serious diabetic complications
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postprandial serum total triglycerides at 4 weeks
- Secondary Outcome Measures
Name Time Method Postprandial total cholesterol at 4 weeks Postprandial total apo B at 4 weeks Postprandial triglycerides in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks Postprandial cholesterol in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks Postprandial apo B-48 and apo B-100 in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇨ðŸ‡Basel, Switzerland