Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control

A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control

This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Inclusion Criteria:

• Subjects with 7.0%≤HbA1c≤10.0% at screening
• Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
• Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
• Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria:

• Subjects with fasting plasma glucose≥240mg/dL at screening
• Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
• Subject with ALT and AST 3 times or higher than upper normal range
• Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening