Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00101673
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
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 12 weeks
- Secondary Outcome Measures
Name Time Method Adverse event profile after 12 weeks of treatment Patients with reduction in HbA1c >/= 0.7% after 12 weeks Change from baseline in fasting plasma glucose at 12 weeks Change from baseline in HOMA-B at 12 weeks Change from baseline in body weight at 12 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇨ðŸ‡Basel, Switzerland