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

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Type2 Diabetes

Treatments: Drug: evogliptin; Drug: Linagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02974504

DA1229_DM_IV

Details and patient eligibility

About

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

Full description

1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks.
2. Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with Evogliptin 5mg for 13-24 weeks

Enrollment: 207 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups

evogliptin

Experimental group

Description:

evogliptin 5mg qd

Treatment:

Drug: evogliptin

linagliptin

Active Comparator group

Description:

linagliptin 5mg qd

Treatment:

Drug: Linagliptin