Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, vildagliptin
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.
Interventions
DRUGvildagliptin
DRUGplacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed