Overview

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

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Treatments:
Metformin
Sitagliptin Phosphate
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