Status:
COMPLETED
Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support reg...
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
- HbA1c in the range of 7.0-10.0%
- Body mass index in the range 20-35 kg/m2
Exclusion
- Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01497522
Start Date
December 1 2011
End Date
February 1 2013
Last Update
February 27 2017
Active Locations (20)
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1
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 810-0001
2
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 819-0168
3
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 800-0296
4
Novartis Investigative Site
Kurume, Fukuoka, Japan, 830-8543