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Recruiting

NCT Number: NCT06972732

A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes

This is a randomized, open-label, active-controlled, parallel, multicenter, phase IV clinical study evaluating the efficacy and safety of switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in patients with type 2 diabetes.

Recruiting

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Key information

Conditions

Type 2 Diabetes 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 4

Primary location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seocho District, 06591, 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

  • Has voluntarily agreed to participate in this clinical trial.
  • Adults over 19 years of age
  • Diagnosed with type 2 diabetes

Exclusion criteria

  • Has severe renal and liver disorders
  • Has type 1 diabetes
  • Those who are participating or have participated in other clinical trials and administered their investigational products within 8 weeks before the screening date for this study
  • Those who are deemed ineligible to participate in the study by the investigator

Treatment and study plan

metformin

Drug

The dosage and dose frequency are maintained as they were before the screening.

Dapagliflozin/Pioglitazone

Drug

Dapagliflozin 10mg/Pioglitazone 30mg QD

Dapagliflozin/Sitagliptin

Drug

Dapagliflozin 10mg/Sitagliptin 100mg QD

Primary outcomes

  1. HbA1c (%) change at 24 weeks compared to the baseline (Visit 2)

    Time frame: From baseline to end of treatment at 24 weeks

    The mean change of HbA1c at 24 weeks compared to the baseline (Visit 2) is evaluated.

Study contacts

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

Oh

CONTACT

[email protected]

+82 2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Randomized, Open-label, Active-controlled, Parallel, Multicenter, Phase IV Clinical Trial to Compare the Efficacy and Safety of Switching Metformin+SGLT2-i+Dipeptidyl Peptidase-4-inhibitor(DPP-4-i) to Metformin+SGLT2-i+TZD in Patients With Type 2 Diabetes

Acronym: TELOS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Sep 15, 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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