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

NCT05505994 — Phase 3, Unknown, 340 participants, Daewoong Pharmaceutical Co. LTD.

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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

Registry	NCT05505994
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	340 (Actual)
Sponsor	Daewoong Pharmaceutical Co. LTD. (Industry)
Conditions	Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
Interventions	DWP16001, Dapagliflozin, DWP16001 Placebo, Dapagliflozin Placebo (Drug)
Dates	start 2022-09-28, primary completion 2024-02-26, completion 2024-09-01 (estimated), first posted 2022-08-18, last updated 2024-04-04
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Study group	Experimental	Drug: DWP16001; Drug: Dapagliflozin Placebo	DWP16001 A mg, Dapagliflozin placebo
Control group	Active comparator	Drug: Dapagliflozin; Drug: DWP16001 Placebo	DWP16001 A mg placebo, Dapagliflozin

DWP16001 (Drug), also known as DWP16001 tablet: DWP16001 A mg tablet
Dapagliflozin (Drug), also known as Dapagliflozin tablet: Dapagliflozin tablet
DWP16001 Placebo (Drug), also known as DWP16001 Placebo tablet: DWP16001 Placebo tablet
Dapagliflozin Placebo (Drug), also known as Dapagliflozin Placebo tablet: Dapagliflozin Placebo tablet

+Outcome measures

Primary outcomes

Change from baseline in HbA1c [at 24 weeks]: Change in HbA1c (%) is assessed with the values measured at the central laboratory

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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)

+Locations (1)

Facility	City	Country	Status
Peking University People's Hospital	Beijing, Beijing Municipality	China

+Investigators

Linong Ji, Dr., Principal investigator, Peking University People's Hospital