Status:
COMPLETED
Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
Lead Sponsor:
Novartis
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by ...
Eligibility Criteria
Inclusion
- Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
- Agreement to maintain the same dose of metformin from randomization to the end of the study
- Age in the range of 18-78 years inclusive
- Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1
- HbA1c in the range of \> 7.0 to ≤10% at Visit 1
- Agreement to maintain prior diet and exercise habits during the full course of the study
- Ability to comply with all study requirements
Exclusion
- Fasting Plasma Glucose (FPG) \> 270 mg/dl (15 mmol/L) at Visit 1
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00822211
Start Date
December 1 2008
End Date
December 1 2009
Last Update
November 18 2016
Active Locations (17)
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1
China-Japan Friendship Hospital
Beijing, China
2
General Hospital of Beijing Military Region of PLA
Beijing, China
3
Peking Union Medical College Hospital
Beijing, China
4
Peking University First Hospital
Beijing, China