ong-term safety study of vildagliptin in patients with type 2 diabetes
Phase 3
- Conditions
- Type 2 Diabetes
- Registration Number
- JPRN-jRCT2080220245
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Both
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
- Not specified
- Primary Outcome Measures
Name Time Method 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;
- Secondary Outcome Measures
Name Time Method