To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00325117
- 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 designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea
- Patients on diet and exercise who have not reached target blood glucose levels
- Outpatients
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Exclusion Criteria
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant cardiovascular complications as defined by the protocol
- Significant diabetic complications as defined by the protocol
Other protocol-defined inclusion/exclusion criteria may apply.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline to endpoint on HbA1c at 12 weeks
- Secondary Outcome Measures
Name Time Method Adverse events profile after 12 weeks of treatment Change from baseline to endpoint on fasting plasma glucose at 12 weeks Change from baseline to endpoint in HOMA IR at 12 weeks Change from baseline to endpoint in HOMA B at 12 weeks Change from baseline to endpoint on fasting lipids at 12 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Tokyo, Japan