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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    190
  • sponsor
    Daewoong Pharmaceutical Co. LTD.
Updated on 27 January 2021

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.

Details
Condition T2DM
Treatment Dapagliflozin
Clinical Study IdentifierNCT04634500
SponsorDaewoong Pharmaceutical Co. LTD.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 19 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have T2DM??
Subjects with T2DM aged 19 to 80 years
Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% HbA1c 10.5%
Subjects with BMI of 20-45 kg/m2
Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria

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)
Diabetic ketoacidosis, diabetic coma or precoma within the past year
Urinary tract infections or genital infections within
Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
eGFR < 60 mL/min/1.73 m2
Severe heart failure (NYHA class III/IV)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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