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

A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of DWP16001 Add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05505994

Enrollment

340

Registered

2022-08-18

Start date

2022-09-28

Completion date

2024-09-30

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGDWP16001

DWP16001 A mg tablet

DRUGDapagliflozin

Dapagliflozin tablet

DRUGDWP16001 Placebo

DWP16001 Placebo tablet

DRUGDapagliflozin Placebo

Dapagliflozin Placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Part 1: Double-blind Part 2: Open label

Intervention model description

Parallel assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in HbA1c	at 24 weeks	Change in HbA1c (%) is assessed with the values measured at the central laboratory

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026