Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Subjects with 6.5%≤HbA1c≤11.0% at screening

• Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening

• Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

• Subjects with fasting plasma glucose≥270mg/dL at screening

• Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus

• Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening

• Subjects with ALT and AST 2.5 times or higher than upper normal range