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

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

— ENHANCE-M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634500
• Other study ID #: DW_DWP16001302
• Status: Completed
• Phase: Phase 3
• Start date: November 18, 2020
• Est. completion date: November 3, 2021

Study information

• Verified date: October 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 200
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• Dapagliflozin
Dapagliflozin Tablet

Locations

Country	Name	City	State
Korea, Republic of	Daewoong pharmatceutical	Soeul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		at 24 weeks