Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, vildagliptin
Brief summary
This study is not being conducted in the United States. 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 vildagliptin, an unapproved drug, compared to that of gliclazide 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
DRUGGliclazide
DRUGMetformin
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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
* Pregnancy or lactation * Type 1 diabetes * Evidence of significant 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 at 52 weeks | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event profile after 52 weeks of treatment | 52 weeks |
| Change from baseline in fasting plasma glucose at 52 weeks | 52 weeks |
| Patients with endpoint HbA1c <7% at 52 weeks | 52 weeks |
| Patients with reduction in HbA1c >/= 0.7% after 52 weeks | 52 weeks |
| Patients with reduction in HbA1c >/= 0.5% after 52 weeks | 52 weeks |
Countries
Germany, Switzerland
Outcome results
None listed