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Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02949193
Collaborator
(none)
222
Enrollment
1
Location
2
Arms
24
Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

  1. Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.

  2. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
222 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: evogliptin

evogliptin 5mg qd add-on to metformin

Drug: evogliptin
evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg
Other Names:
  • Suganon

    		•
    Active Comparator: sitagliptin

    sitagliptin 100mg qd add-on to metformin

    Drug: Sitagliptin
    sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg
    Other Names:
  • januvia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HbA1c [Change from baseline at 24 week]

      unit: %

    Secondary Outcome Measures

    1. fasting plasma glucose [Change from baseline at 24 week]

      unit : mg/dL

    2. HOMA-beta [Change from baseline at 24 week]

      unit: %

    3. HbA1c response rate [Change from baseline at 24 weeks]

      unit: %

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects with 6.5%≤HbA1c≤11.0% at screening

    • Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before 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 6 months prior to screening

    • Subjects with ALT and AST 2.5 times or higher than upper normal range

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kangbuk Samsung Medical Center Seoul Korea, Republic of 110-746

    Sponsors and Collaborators

    • Dong-A ST Co., Ltd.

    Investigators

    • Principal Investigator: Sung Woo Park, M.D., Ph.D., Kangbuk Samsung Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02949193
    Other Study ID Numbers:
    • DA1229_DMC_III
    First Posted:
    Oct 31, 2016
    Last Update Posted:
    Oct 31, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Oct 31, 2016