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

Daewoong Pharmaceutical

Status and phase: Active, not recruiting; Phase 3

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

Treatments: Drug: DWP16001; Drug: Dapagliflozin Placebo; Drug: Dapagliflozin; Drug: DWP16001 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05505994

DW_DWP16001304_CN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 2 patient groups

Study group

Experimental group

Description:

DWP16001 A mg, Dapagliflozin placebo

Treatment:

Drug: Dapagliflozin Placebo

Drug: DWP16001

Control group

Active Comparator group

Description:

DWP16001 A mg placebo, Dapagliflozin

Treatment:

Drug: DWP16001 Placebo

Drug: Dapagliflozin