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 vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.
Interventions
DRUGpioglitazone
pioglitazone 45 mg qd
DRUGPlacebo
Vildagliptin matching placebo
DRUGVildagliptin
Vildagliptin 50 mg tablets
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Blood glucose criteria must be met * Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone * Body mass index (BMI) in the range 22-45
Exclusion criteria
* Type 1 diabetes * Pregnancy or lactation * Evidence of serious cardiovascular complications * Evidence of serious diabetic 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 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 | — |
| Adverse event profile after 24 weeks of treatment | — |
| Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c | — |
Countries
United States
Outcome results
None listed