Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
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.
Interventions
DRUGvildagliptin
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial serum total triglycerides at 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Switzerland
Outcome results
None listed