CClinicalTrials.gg
RecruitingNCT06972732TELOSUpdated Sep 15, 2025

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

A Phase 4 interventional study of Metformin and Dapagliflozin/Pioglitazone in Type 2 Diabetes, sponsored by Boryung Pharmaceutical Co., Ltd. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • type 2 diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 204 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
204 participants (estimated)

Study arms

  • Experimental
    Metformin + Dapagliflozin 10mg/Pioglitazone 30mg

    One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.

    Drug: Metformin · Drug: Dapagliflozin/Pioglitazone

  • Active comparator
    Metformin + Dapagliflozin 10mg/Sitagliptin 100mg

    One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.

    Drug: Metformin · Drug: Dapagliflozin/Sitagliptin

Interventions

  • DrugMetformin

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

  • DrugDapagliflozin/Pioglitazone

    Dapagliflozin 10mg/Pioglitazone 30mg QD

  • DrugDapagliflozin/Sitagliptin

    Dapagliflozin 10mg/Sitagliptin 100mg QD

06

What researchers measure

Primary outcomes

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

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

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

07

Study locations

1 of 1 sites recruiting
  • The Catholic University of Korea, Seoul St. Mary's Hospital
    Seoul, Seocho District 06591, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06972732
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
May 15, 2025
Start date
Jun 11, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Sep 15, 2025

Study contacts

Oh
Contact
syoh@boryung.co.kr
+82 2-708-8000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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