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

A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes

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

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.
2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

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