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The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin

Primary Purpose

Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DWP16001
Dapagliflozin
DWP16001 Placebo
Dapagliflozin Placebo
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action, Hypoglycemic Agents, Physiological Effects of Drugs

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects with T2DM aged 18 to 80 years
  2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
  3. Subjects with BMI of 20-45 kg/m2
  4. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

  1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
  2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
  3. Urinary tract infections or genital infections within
  4. Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
  5. eGFR < 60 mL/min/1.73 m2
  6. Severe heart failure (NYHA class III/IV)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Study group

    Control group

    Arm Description

    DWP16001 A mg, Dapagliflozin placebo

    DWP16001 A mg placebo, Dapagliflozin

    Outcomes

    Primary Outcome Measures

    Change from baseline in HbA1c
    Change in HbA1c (%) is assessed with the values measured at the central laboratory

    Secondary Outcome Measures

    Full Information

    First Posted
    August 16, 2022
    Last Updated
    August 24, 2022
    Sponsor
    Daewoong Pharmaceutical Co. LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05505994
    Brief Title
    The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
    Official Title
    A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Study to Evaluate the Efficacy and Safety of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Daewoong Pharmaceutical 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
    Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
    Detailed Description
    A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
    Keywords
    Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action, Hypoglycemic Agents, Physiological Effects of Drugs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Double-blinded
    Allocation
    Randomized
    Enrollment
    298 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    DWP16001 A mg, Dapagliflozin placebo
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    DWP16001 A mg placebo, Dapagliflozin
    Intervention Type
    Drug
    Intervention Name(s)
    DWP16001
    Other Intervention Name(s)
    DWP16001 tablet
    Intervention Description
    DWP16001 A mg tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Dapagliflozin
    Other Intervention Name(s)
    Dapagliflozin tablet
    Intervention Description
    Dapagliflozin tablet
    Intervention Type
    Drug
    Intervention Name(s)
    DWP16001 Placebo
    Other Intervention Name(s)
    DWP16001 Placebo tablet
    Intervention Description
    DWP16001 Placebo tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Dapagliflozin Placebo
    Other Intervention Name(s)
    Dapagliflozin Placebo tablet
    Intervention Description
    Dapagliflozin Placebo tablet
    Primary Outcome Measure Information:
    Title
    Change from baseline in HbA1c
    Description
    Change in HbA1c (%) is assessed with the values measured at the central laboratory
    Time Frame
    at 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with T2DM aged 18 to 80 years Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5% Subjects with BMI of 20-45 kg/m2 Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors) Diabetic ketoacidosis, diabetic coma or precoma within the past year Urinary tract infections or genital infections within Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) eGFR < 60 mL/min/1.73 m2 Severe heart failure (NYHA class III/IV)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hojun Ryu, PharmD
    Phone
    +82 0 550 8800
    Email
    hjryu71@daewoong.co.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Linong Ji, Dr.
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin

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