Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00099918
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone 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
- 717
Inclusion Criteria
- Blood glucose criteria must be met
- Not currently on drug therapy for type 2 diabetes
- 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 conditions
- Laboratory value abnormalities as defined by the protocol
- 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 Patients with reduction in HbA1c >/= 0.7% after 24 weeks Change from baseline in fasting plasma glucose at 24 weeks Adverse event profile after 24 weeks of treatment Patients with endpoint HbA1c <7% at 24 weeks Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c
Trial Locations
- Locations (2)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States
Novartis Investigative Sites
🇩🇪Investigative Centers, Germany