Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes

A Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-5218 in patients with type 2 diabetes who have inadequate glycemic control with metformin

Inclusion Criteria:

• 7.0%≤HbA1c≤10.5% and fasting glucose≤270mg/dL
• Treated with 1,000mg/day dose of metformin for at least 8 weeks

Exclusion Criteria:

• Type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
• eGFR<45mL/min/1.73m2
• ALT and AST 3 times or higher than upper normal range
• Determined by investigator as unfit to participate in a clinical trial due to other reasons