NCT00389415
Completed
Phase 3
A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin (100 mg qd) In Patients With Type 2 Diabetes (Extension Study of Study CLAF237A1303)
ConditionsDiabetes Mellitus, Type 2
DrugsVildagliptin
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Novartis
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Adverse events profile after 52 weeks of treatment
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adverse events profile after 52 weeks of treatment
Secondary Outcomes
- 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
Study Sites (1)
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