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NCT05505994 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05505994
Other study ID # DW_DWP16001304_CN
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 28, 2022
Est. completion date September 2024

Study information
Verified date April 2024
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 340
Est. completion date September 2024
Est. primary completion date February 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWP16001
DWP16001 A mg tablet
• Dapagliflozin
Dapagliflozin tablet
• DWP16001 Placebo
DWP16001 Placebo tablet
• Dapagliflozin Placebo
Dapagliflozin Placebo tablet

Locations
Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

China, 

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