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

Phase 3

Completed

• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT04634500
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Study Timeline

• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-17
• Study Start: 2020-11-18
• Study First Posted: 2020-11-18
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Dapagliflozin	DWP16001 A mg, Dapagliflozin placebo
Control group	Dapagliflozin	DWP16001 A mg placebo, Dapagliflozin

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	at 24 weeks

Trial Locations

Locations (1)

Daewoong pharmatceutical; 🇰🇷 Soeul, Korea, Republic of