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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05505994

Collaborator

(none)

298

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases	Drug: DWP16001 Drug: Dapagliflozin Tablet	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

298 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel assignmentParallel assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double-blinded

Primary Purpose:

Treatment

Official Title:

A Multi-center, Randomized, Double-Blind, Active-controlled, Phase3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group DWP16001 A mg, Dapagliflozin placebo	Drug: DWP16001 DWP16001 A mg, Dapagliflozin placebo Other Names: Dapagliflozin placebo tablet
Active Comparator: Control group DWP16001 A mg placebo, Dapagliflozin	Drug: Dapagliflozin Tablet DWP16001 A mg placebo, Dapagliflozin Other Names: DWP16001 placebo tablet

Arm

Intervention/Treatment

Experimental: Study group

DWP16001 A mg, Dapagliflozin placebo

Drug: DWP16001

DWP16001 A mg, Dapagliflozin placebo

Other Names:

Dapagliflozin placebo tablet

Active Comparator: Control group

DWP16001 A mg placebo, Dapagliflozin

Drug: Dapagliflozin Tablet

DWP16001 A mg placebo, Dapagliflozin

Other Names:

DWP16001 placebo tablet

Outcome Measures

Primary Outcome Measures

Change from baseline in HbA1c [at 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)