Status:
COMPLETED
Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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-g...
Eligibility Criteria
Inclusion
- 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
- Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Significant diabetic complications
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT01159249
Start Date
June 1 2010
End Date
January 1 2012
Last Update
December 17 2020
Active Locations (24)
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1
Novartis Investigative Site
Hunabashi, Chiba, Japan, 274-0805
2
Novartis Investigative Site
Chikushino-shi, Fukuoka, Japan, 818-0036
3
Novartis Investigative Site
Itoshima-shi, Fukuoka, Japan, 819-1102
4
Novartis Investigative Site
Kōriyama, Fukushima, Japan, 963-8851