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Completed

NCT Number: NCT06571591

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

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.

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Key information

Conditions

T2DM

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Celltrion

Incheon, South Korea

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

CT-L03 Group 1

Drug

tablets, QD, oral administration

CT-L03 Group 2

Drug

tablets, QD, oral administration

Placebo

Drug

tablets, QD, oral administration

Empagliflozin

Drug

tablet, QD, oral administration

metformin

Drug

tablets, oral administration

Primary outcomes

  1. HbA1c

    Time frame: Week 24 of the Treatment

    Change from Baseline in HbA1c

Secondary outcomes

  1. HbA1c

    Time frame: Week 12 of the Treatment

    Change from Baseline in HbA1c

  2. FPG

    Time frame: Week 12 and 24 of the Treatment

    Change from Baseline in fasting plasma glucose

  3. Body weight

    Time frame: Week 12 and 24 of the Treatment

    Change from Baseline in body weight

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Acronym: CT-L03

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
May 15, 2026

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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