Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes
- Registration Number
- NCT01159249
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
Inclusion Criteria
- patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
- Age in the 20 years or over inclusive
- HbA1c in the range of ≥ 6.5 to ≤ 10%
Exclusion Criteria
- Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Significant diabetic complications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open TZD add-on vildagliptin Vildagliptin - Open α-GI add-on vildagliptin Vildagliptin - Glinides add-on vildagliptin Vildagliptin - Open Met add-on vildagliptin Vildagliptin -
- Primary Outcome Measures
Name Time Method Measure AEs, vital signs, laboratory evaluations 52 weeks
- Secondary Outcome Measures
Name Time Method Fasting Insulin 52 weeks Fasting C-peptide 52 weeks HBA1c 52 weeks Fasting Plasma Glucose 52 weeks HOMA-B 52 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Fukuoka, Japan
Novartis Investigative Site🇯🇵Fukuoka, Japan