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Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Primary Purpose

Diabetes Mellitus

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
DA-2811
Forxiga
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with 7.0%≤HbA1c≤10.0% at screening Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study Exclusion Criteria: Subjects with fasting plasma glucose≥240mg/dL at screening Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus Subject with ALT and AST 3 times or higher than upper normal range Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DA-2811

    Forxiga

    Arm Description

    DA-2811 + Forxiga placebo

    Forxiga + DA-2811 placebo

    Outcomes

    Primary Outcome Measures

    HbA1c(%)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 15, 2023
    Last Updated
    February 15, 2023
    Sponsor
    Dong-A ST Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05743907
    Brief Title
    Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
    Official Title
    A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dong-A ST Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    232 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DA-2811
    Arm Type
    Experimental
    Arm Description
    DA-2811 + Forxiga placebo
    Arm Title
    Forxiga
    Arm Type
    Active Comparator
    Arm Description
    Forxiga + DA-2811 placebo
    Intervention Type
    Drug
    Intervention Name(s)
    DA-2811
    Intervention Description
    DA-2811 Group: DA-2811 + Forxiga placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Forxiga
    Intervention Description
    Forxiga Group: Forxiga + DA-2811 placebo
    Primary Outcome Measure Information:
    Title
    HbA1c(%)
    Time Frame
    Change from baseline at 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with 7.0%≤HbA1c≤10.0% at screening Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study Exclusion Criteria: Subjects with fasting plasma glucose≥240mg/dL at screening Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus Subject with ALT and AST 3 times or higher than upper normal range Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

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