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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02974504
Collaborator
(none)
207
Enrollment
1
Location
2
Arms
17.9
Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
207 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: evogliptin

evogliptin 5mg qd

Drug: evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
Active Comparator: linagliptin

linagliptin 5mg qd

Drug: Linagliptin
linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg
Other Names:
  • Tragenta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HbA1c [Change from baseline at 12 week]

      unit: %

    Secondary Outcome Measures

    1. fasting plasma glucose [Change from baseline at 12 week]

      unit : mg/dL

    2. HbA1c response rate [Change from baseline at 12 weeks]

      unit: %

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul Korea, Republic of

    Sponsors and Collaborators

    • Dong-A ST Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02974504
    Other Study ID Numbers:
    • DA1229_DM_IV
    First Posted:
    Nov 28, 2016
    Last Update Posted:
    Jul 23, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Linagliptin

    Study Results

    No Results Posted as of Jul 23, 2018