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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Part 1: Double-blind Part 2: Open label

Study Groups

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Study group

DWP16001 A mg, Dapagliflozin placebo

Group Type EXPERIMENTAL

DWP16001

Intervention Type DRUG

DWP16001 A mg tablet

Dapagliflozin Placebo

Intervention Type DRUG

Dapagliflozin Placebo tablet

Control group

DWP16001 A mg placebo, Dapagliflozin

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

Dapagliflozin tablet

DWP16001 Placebo

Intervention Type DRUG

DWP16001 Placebo tablet

Interventions

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DWP16001

DWP16001 A mg tablet

Intervention Type DRUG

Dapagliflozin

Dapagliflozin tablet

Intervention Type DRUG

DWP16001 Placebo

DWP16001 Placebo tablet

Intervention Type DRUG

Dapagliflozin Placebo

Dapagliflozin Placebo tablet

Intervention Type DRUG

Other Intervention Names

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DWP16001 tablet Dapagliflozin tablet DWP16001 Placebo tablet Dapagliflozin Placebo tablet

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No