NCT00351832CompletedPhase 3
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin (50mg qd, 50mg Bid, 100mg qd) to Placebo in Patients With Type 2 Diabetes
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Change from baseline on HbA1c at 12 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from baseline on HbA1c at 12 weeks
Secondary Outcomes
- 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
Investigators
Study Sites (1)
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