Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00389415
- Lead Sponsor
- Novartis
- Brief Summary
This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Diagnosis as Type 2 Diabetes
- Patients who have completed study CLAF237A1303
- Outpatients
Exclusion Criteria
- Patients who prematurely discontinued Study CLAF237A1303
- Other protocol-defined inclusion/exclusioncriterial 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 on fasting plasma glucose at 52 weeks Change from baseline to endpoint in HOMA B at 52 weeks Change from baseline to endpoint in HOMA IR at 52 weeks Change from baseline to endpoint in body weight at 52 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Tokyo, Japan