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NCT Number: NCT07093476

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

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.

Recruiting

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Key information

Conditions

T2DM DM Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Celltrion

Seoul, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

tablets, QD, oral administration

Alogliptin

Drug

tablets, QD, oral administration

Empagliflozin

Drug

tablets, QD, oral administration

Primary outcomes

  1. HbA1c

    Time frame: Week 24 of the Treatment

    Change from Baseline in HbA1c

Study contacts

Contact information is provided by the study sponsor or research team.

Celltrion, Inc.

CONTACT

[email protected]

+82 3403 9647

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 30, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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