Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00101803
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 527
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 exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at 24 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States