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 long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
Interventions
DRUGvildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Inclusion criteria
* On a stable dose of metformin as defined by the protocol * Blood glucose criteria must be met * Body mass index (BMI) in the range 22-45
Exclusion criteria
* History of type 1 diabetes * Pregnancy or lactation * Evidence of significant diabetic complications * Serious cardiovascular events within the past 6 months * Laboratory value abnormalities as defined by the protocol * Known sensitivity to pioglitazone * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event profile after 52 weeks of treatment | — |
| Change from baseline in fasting plasma glucose at 52 weeks | — |
| Change from baseline in body weight at 52 weeks | — |
| Patients with endpoint HbA1c < 7% after 52 weeks | — |
| Patients with reduction in HbA1c >/= to 7% after 52 weeks | — |
Countries
Germany, United States
Outcome results
None listed