A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin

March 26, 2017 updated by: Dong-A ST Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin After Oral Administration in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise

This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks.
  2. Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with 6.5%≤HbA1c≤10.0% at screening
  • Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening
  • Subjects with 6.5%≤HbA1c≤10.0% at Visit 2
  • 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 6 months prior to screening
  • Subjects with ALT and AST 2.5 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 5mg
evogliptin 5mg QD
Drug: evogliptin 5mg
evogliptin 5mg, QD
Other Names:
  • Suganon
  • DA-1229
Placebo Comparator: placebo
Placebo QD
Drug: Placebo
Placebo, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Change from baseline at 24 weeks
unit: %
Change from baseline at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c response rate
Time Frame: Change from baseline at 24 weeks
unit: %
Change from baseline at 24 weeks
fasting plasma glucose
Time Frame: Change from baseline at 24 weeks
unit: mg/dL
Change from baseline at 24 weeks

Collaborators and Investigators

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

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Doo Man Kim, M.D., Ph.D., Kangdong Sacred Heart Hospital

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

July 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 23, 2014

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 26, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_DMM_III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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