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

Launched by DONG-A ST CO., LTD. · Oct 27, 2016

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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