A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin After Oral Administration in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise

This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks.
2. Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.

Inclusion Criteria:

• Subjects with 6.5%≤HbA1c≤10.0% at screening
• Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening
• Subjects with 6.5%≤HbA1c≤10.0% at Visit 2
• 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