NCT07093476

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T2DM
• Diabete Type 2
• DM

Interventions

Type	Name	Description
DRUG	Metformin	tablets, QD, oral administration
DRUG	Alogliptin	tablets, QD, oral administration
DRUG	empagliflozin	tablets, QD, oral administration

Timeline

• Start date: 2025-07-18
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2025-07-30
• Last updated: 2025-08-11

Locations

1 site across 1 country: South Korea