A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00351832
- Lead Sponsor
- Novartis
- Brief Summary
This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
Inclusion Criteria
- Diagnosis of type 2 diabetes
- Patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control
- Outpatients
Exclusion Criteria
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant cardiovascular disease
- Significant diabetic complications
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline on HbA1c at 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline on fasting plasma glucose at 12 weeks Change from baseline on HOMA B at 12 weeks Change from baseline on HOMA IR at 12 weeks Change from baseline in body weight at 12 weeks Change from baseline on fasting lipids at 12 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Tokyo, Japan
Novartis Pharmaceuticals🇯🇵Tokyo, Japan