Status:
COMPLETED
Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Handok Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The study design of this trial is open-label, randomized, multi-center, parallel-group study.
Detailed Description
* The progressive nature of T2DM will require the use of combination therapy in many patients over time to achieve and maintain glycemic control. Early combination, compared with maximal dose of monot...
Eligibility Criteria
Inclusion
- Patients with Type 2 Diabetes Mellitus who were inadequately controlled (baseline A1c of 7.0\~11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit
- Age of 18-80 years
- Body Mass Index of 18-40 kg/m2
Exclusion
- Type 1 of diabetes
- Myocardial Infarction, Unstable Angina, or Coronary Artery Bypass Graft within the previous 6 months
- Congestive Heart Failure (III or NYHA class IV)
- Liver disease such as cirrhosis or Chronic Active Hepatitis
- History of Lacticacidemia
- Use of any Oral Anti-diabetic Drug other than Metformin within the 2 months
- Use of insulin before screening visit
- ALT or AST \>3 times the upper limit of Normal range
- Creatinine \>1.5 mg/dl
- Other situation (pregnant or lactating females, history of drug or alcohol abuse, night-shift workers, clinically significant laboratory abnormality on screening or any medical condition that would affect the completion or outcome of the study)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT00975065
Start Date
August 1 2009
End Date
April 1 2012
Last Update
August 23 2012
Active Locations (1)
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1
Handok Pharmaceuticals
Seoul, Seoul, South Korea