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

NCT06972732 — Phase 4, Recruiting, 204 participants, Boryung Pharmaceutical Co., Ltd
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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

RegistryNCT06972732, acronym TELOS
StatusRecruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment204 (Estimated)
SponsorBoryung Pharmaceutical Co., Ltd (Industry)
ConditionsType 2 Diabetes
InterventionsMetformin, Dapagliflozin/Pioglitazone, Dapagliflozin/Sitagliptin (Drug)
Datesstart 2025-06-11, primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2025-05-15, last updated 2025-09-15
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Type 2 Diabetes All trials of Metformin All trials of Dapagliflozin/Pioglitazone

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Metformin + Dapagliflozin 10mg/Pioglitazone 30mgExperimentalDrug: Metformin; Drug: Dapagliflozin/PioglitazoneOne tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.
Metformin + Dapagliflozin 10mg/Sitagliptin 100mgActive comparatorDrug: Metformin; Drug: Dapagliflozin/SitagliptinOne tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.
  • 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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

FacilityCityCountryStatus
The Catholic University of Korea, Seoul St. Mary's HospitalSeoul, Seocho DistrictSouth KoreaRecruiting