Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin
Lead Sponsor:
Celltrion
Conditions:
T2DM
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
Phase 3 study to assess the Efficacy and Safety of CT-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy.
Eligibility Criteria
Inclusion
- Adults at the time of signing the Informed Consent Form (ICF)
- Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study
- Diagnosed with T2DM
Exclusion
- Diagnosed with other types of diabetes than T2DM
- History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy
- Uncontrolled severe complications of diabetes
Key Trial Info
Start Date :
August 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
582 Patients enrolled
Trial Details
Trial ID
NCT06571591
Start Date
August 27 2024
End Date
May 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
Celltrion
Incheon, South Korea