Status:
UNKNOWN
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
19-79 years
Phase:
PHASE3
Brief Summary
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exc...
Detailed Description
The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exc...
Eligibility Criteria
Inclusion
- Subjects with T2DM age 19 \~ under 80 years
- Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1)
- Subjects who have FPG \<270 mg/dl screening visit(V1-1)
- Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit)
- Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
Exclusion
- 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 \< 45 mL/min/1.73 m2
- Severe heart failure (NYHA class III/IV
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06141980
Start Date
December 1 2023
End Date
September 1 2025
Last Update
November 21 2023
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