Long-Term Safety Study of Vildagliptin in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00325429
- Lead Sponsor
- Novartis
- Brief Summary
This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Diagnosis of type 2 diabetes
- Patients who have been placed on diet and exercise therapy without achieving target blood glucose levels
- Outpatients
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events profile after 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method Change from baseline to endpoint on HbA1c at 52 weeks Change from baseline to endpoint in body weight at 52 weeks Change from baseline to endpoint on fasting plasma glucose at 52 weeks Change from baseline to endpoint in HOMA IR at 52 weeks Change from baseline to endpoint in HOMA B at 52 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Tokyo, Japan