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 the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Not previously treated with oral antidiabetic agents 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 serious diabetic complications * Evidence of serious cardiovascular complications * 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 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose at 24 weeks | — |
| Adverse event profile after 24 weeks of treatment | — |
| Patients with endpoint HbA1c <7% after 24 weeks | — |
| Patients with endpoint HbA1C <6.5% after 24 weeks | — |
| Patients with reduction in HbA1c >/= to 0.7% after 24 weeks | — |
Countries
United States
Outcome results
None listed