Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
Brief summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.
Interventions
DRUGvildagliptin
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Blood glucose criteria must be met * On a stable dose of metformin as defined by the protocol * Body mass index (BMI) in the range 22-45
Exclusion criteria
* Type 1 diabetes * Pregnancy or lactation * Evidence of serious diabetic complications * Evidence of serious cardiovascular complications * Laboratory value abnormalities as defined by the protocol * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose at 24 weeks | — |
| Patients with endpoint HbA1c <7% after 24 weeks | — |
| Patients with reduction in HbA1c >/=to 0.7% after 24 weeks | — |
| Change from baseline in body weight at 24 weeks | — |
| Change from baseline in fasting lipids at 24 weeks | — |
Countries
United States
Outcome results
None listed