A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Celltrion
RECRUITING
Seoul
Contact Information
Primary
Celltrion, Inc.
sanghee.byun@celltrion.com
+82 3403 9647
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2027-04
Participants
Target number of participants: 171
Treatments
Active_comparator: Study group 1
Metformin + Alogliptin + Empagliflozin Xmg
Active_comparator: Study group 2
Metformin + Alogliptin + Empagliflozin Ymg
Placebo_comparator: Control Group
Metformin + Alogliptin
Related Therapeutic Areas
Sponsors
Leads: Celltrion