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Search / Trial NCT06571591

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

Launched by CELLTRION · Aug 23, 2024

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for adults with Type 2 diabetes (T2DM) who are not achieving good blood sugar control with their current medications, Metformin and Empagliflozin. The treatment being studied is called Pioglitazone, and the trial aims to find out if adding this medication can help improve blood sugar levels safely. This is a Phase 3 study, which means it is one of the final stages of testing before the treatment can potentially be approved for general use.

To participate in this trial, you need to be an adult diagnosed with Type 2 diabetes and willing to sign a consent form to join the study. However, if you have another type of diabetes, a history of severe allergic reactions to diabetes medications, or serious uncontrolled complications from diabetes, you won't be eligible. If you do join, you can expect regular check-ups and monitoring to see how well the new treatment works for you. This trial is currently recruiting participants, so it's a great opportunity for those looking for additional support in managing their diabetes.

Gender

ALL

Eligibility criteria

  • 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

About Celltrion

Celltrion is a global biopharmaceutical company dedicated to the development and commercialization of innovative biologics and biosimilars. Founded in South Korea, Celltrion leverages advanced biotechnology to create high-quality therapeutics that address unmet medical needs in various therapeutic areas, including oncology, autoimmune diseases, and infectious diseases. With a strong commitment to research and development, Celltrion aims to enhance patient access to effective treatments while ensuring rigorous compliance with international regulatory standards. The company is recognized for its expertise in monoclonal antibody production and its pioneering role in the biosimilar market, positioning itself as a leader in the biopharmaceutical industry.

Locations

Incheon, Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported