RecruitingPhase 3NCT07093476

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

Sponsor

Celltrion

Enrollment

171 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Diabete Type 2 T2DM DM

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the effectiveness and safety of adding empagliflozin (a diabetes medication that helps lower blood sugar through the kidneys) to the existing combination of alogliptin and metformin in people with type 2 diabetes. The goal is to see if this three-drug combination helps control blood sugar better. **You may be eligible if...** - You are an adult (18 years or older) - You have been diagnosed with type 2 diabetes - You are willing to sign an informed consent form **You may NOT be eligible if...** - You have a different type of diabetes (e.g., type 1 diabetes) - You have had a serious allergic reaction to empagliflozin, alogliptin, or metformin, or similar medications - You have severe and uncontrolled diabetes complications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

tablets, QD, oral administration

DRUGAlogliptin

tablets, QD, oral administration

DRUGempagliflozin

tablets, QD, oral administration

Locations(1)

Celltrion

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07093476

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