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Recruiting Phase 3 NCT07093476

Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin

Trial Parameters

Condition T2DM
Sponsor Celltrion
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 171
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2025-07-18
Completion 2026-12
Interventions
MetforminAlogliptinempagliflozin

Brief Summary

Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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