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

July 19, 2018 updated by: Dong-A ST Co., Ltd.

A Multicenter, Randomized, Double-blind, Active-contrelled, Parallel-group, Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin After Oral Administration in Patiend With Type 2 Diabetes

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

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: evogliptin
evogliptin 5mg qd
evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
Active Comparator: linagliptin
linagliptin 5mg qd
linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg
Other Names:
  • Tragenta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Change from baseline at 12 week
unit: %
Change from baseline at 12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting plasma glucose
Time Frame: Change from baseline at 12 week
unit : mg/dL
Change from baseline at 12 week
HbA1c response rate
Time Frame: Change from baseline at 12 weeks
unit: %
Change from baseline at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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