Status:
COMPLETED
Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)
Lead Sponsor:
Novartis
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-78 years
Phase:
PHASE4
Brief Summary
This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.
Eligibility Criteria
Inclusion
- Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months
- The patient is required to have HbA1c 6.5-11.0%
- BMI in the range of 22-48 kg/m2
Exclusion
- Severe or uncontrolled Type 2 diabetes mellitus (HbA1c\> 11.0%)
- Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- Congestive heart failure requiring pharmacologic treatment
- Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention
- Liver disease such as cirrhosis or chronic active hepatitis
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT01196546
Start Date
March 1 2010
End Date
October 1 2011
Last Update
August 1 2017
Active Locations (8)
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1
BMA Medical College and Vajira Hospital
Bangkok, Thailand
2
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
3
Phamongkutklao Hospital
Bangkok, Thailand
4
Police General Hospital
Bangkok, Thailand