Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
- Registration Number
- NCT00102388
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1092
Inclusion Criteria
- Not currently on drug therapy for type 2 diabetes
- Body mass index (BMI) in the range 22-45
- Blood glucose criteria must be met
Exclusion Criteria
- Pregnancy or lactation
- Type 1 diabetes
- Evidence of significant 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
- Arm && Interventions
Group Intervention Description vildagliptin vildagliptin - Gliclazide Gliclazide -
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at 104 weeks 104 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in fasting plasma glucose at 104 weeks 104 weeks Patients with reduction in HbA1x >/= 0.5% after 104 weeks 104 weeks Adverse event profile at 104 weeks 104 weeks Patients with endpoint HbA1c <7% after 104 weeks 104 weeks Patients with reduction in HbA1c >/= 0.7% after 104 weeks 104 weeks
Trial Locations
- Locations (2)
Novartis Investigative Site
🇩🇪Investigative Centers, Germany
Novartis Pharmaceuticals
🇨ðŸ‡Basel, Switzerland