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

Study Overview
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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.

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.

Official Title
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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

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

Intervention / Treatment
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* Drug: DWP16001
* Drug: Dapagliflozin
* Drug: DWP16001 Placebo
* Drug: Dapagliflozin Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>DWP16001 A mg, Dapagliflozin placebo | Drug: DWP16001<br>* DWP16001 A mg tablet<br>* Other names: DWP16001 tablet;Drug: Dapagliflozin Placebo<br>* Dapagliflozin Placebo tablet<br>* Other names: Dapagliflozin Placebo tablet;|
| Active Comparator: Control group<br>DWP16001 A mg placebo, Dapagliflozin | Drug: Dapagliflozin<br>* Dapagliflozin tablet<br>* Other names: Dapagliflozin tablet;Drug: DWP16001 Placebo<br>* DWP16001 Placebo tablet<br>* Other names: DWP16001 Placebo tablet;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action, Hypoglycemic Agents, Physiological Effects of Drugs