Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00237237
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 588
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 exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at 52 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Investigative Centers
π©πͺNurnberg, Germany
Novartis Pharmaceuticals
πΊπΈEast Hanover, New Jersey, United States