NCT06571591

Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin

A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone Co-administration in Patients With Type II Diabetes With Insufficient Glycemic Control With Metformin and Empagliflozin Combination Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 582 (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-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy.

Conditions

• T2DM

Interventions

Type	Name	Description
DRUG	CT-L03 Group 1	tablets, QD, oral administration
DRUG	CT-L03 Group 2	tablets, QD, oral administration
DRUG	Placebo	tablets, QD, oral administration
DRUG	Empagliflozin	tablet, QD, oral administration
DRUG	Metformin	tablets, oral administration

Timeline

• Start date: 2024-08-27
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-08-26
• Last updated: 2025-11-19

Locations

1 site across 1 country: South Korea