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
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Galvus
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- Handok Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Galvus group
Diabex group
the combination of metformin plus Vildagliptin: vildagliptin 50 mg bid plus metformin 1500mg Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy.
metformin alone arm: metformin 1500mg plus metformin 500mg or 1000mg Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy