A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Dong-A ST Co., Ltd.

Criteria

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