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
TELOS
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
1 other identifier
interventional
204
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes
Started Jun 2025
Shorter than P25 for phase_4 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2025
CompletedFirst Posted
Study publicly available on registry
May 15, 2025
CompletedStudy Start
First participant enrolled
June 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
September 15, 2025
September 1, 2025
1.3 years
May 7, 2025
September 11, 2025
Conditions
Keywords
Outcome Measures
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.
From baseline to end of treatment at 24 weeks
Study Arms (2)
Metformin + Dapagliflozin 10mg/Pioglitazone 30mg
EXPERIMENTALOne tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.
Metformin + Dapagliflozin 10mg/Sitagliptin 100mg
ACTIVE COMPARATOROne tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.
Interventions
The dosage and dose frequency are maintained as they were before the screening.
Dapagliflozin 10mg/Pioglitazone 30mg QD
Dapagliflozin 10mg/Sitagliptin 100mg QD
Eligibility Criteria
You may qualify if:
- Has voluntarily agreed to participate in this clinical trial.
- Adults over 19 years of age
- Diagnosed with type 2 diabetes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seocho District, 06591, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2025
First Posted
May 15, 2025
Study Start
June 11, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share