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

Phase 4

Completed

• Conditions: Type2 Diabetes
• Interventions: Drug: Linagliptin; Drug: evogliptin

• Registration Number: NCT02974504
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief 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

Detailed 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

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-28
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
linagliptin	Linagliptin	linagliptin 5mg qd
evogliptin	evogliptin	evogliptin 5mg qd

Primary Outcome Measures

Name	Time	Method
HbA1c	Change from baseline at 12 week	unit: %

Secondary Outcome Measures

Name	Time	Method
fasting plasma glucose	Change from baseline at 12 week	unit : mg/dL
HbA1c response rate	Change from baseline at 12 weeks	unit: %

Trial Locations

Locations (1)

Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of