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

NCT ID: NCT02974504

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-03-31

Brief Summary

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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

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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

Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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evogliptin

evogliptin 5mg qd

Group Type EXPERIMENTAL

evogliptin

Intervention Type DRUG

evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg

linagliptin

linagliptin 5mg qd

Group Type ACTIVE_COMPARATOR

Linagliptin

Intervention Type DRUG

linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg

Interventions

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evogliptin

evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg

Intervention Type DRUG

Linagliptin

linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg

Intervention Type DRUG

Other Intervention Names

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Tragenta

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA1229_DM_IV

Identifier Type: -

Identifier Source: org_study_id

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