Overview

Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)

Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
0
Participant gender:
All
Summary
A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV clinical trial to investigate the effect on blood glucose of evogliptin after oral administration in patients with type 2 diabetes
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Treatments:
Linagliptin
Criteria
Inclusion Criteria:

- Subjects with 7.0%≤HbA1c≤10.0% at screening

- Subjects untreated with oral hypoglycemic agents within 8 weeks prior to
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 24 weeks
prior to screening

- Subjects with ALT and AST 3 times or higher than upper normal range