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The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes. (ENHANCE-M)

Primary Purpose

T2DM (Type 2 Diabetes Mellitus)

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dapagliflozin
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

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

Inclusion Criteria:

  1. Subjects with T2DM aged 19 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

  • Daewoong pharmatceutical

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

Secondary Outcome Measures

Full Information

First Posted
November 12, 2020
Last Updated
October 23, 2022
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT04634500
Brief Title
The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
Acronym
ENHANCE-M
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

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
Data Monitoring Committee
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
T2DM (Type 2 Diabetes Mellitus)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

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)
Dapagliflozin
Other Intervention Name(s)
DWP16001
Intervention Description
Dapagliflozin Tablet
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
at 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with T2DM aged 19 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)
Facility Information:
Facility Name
Daewoong pharmatceutical
City
Soeul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.

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