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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study design of this trial is open-label, randomized, multi-center, parallel-group study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Metformin; Vildagliptin

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)