Type 2 DiabetesPhase 4TELOSNCT06972732
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 study testing Metformin, Dapagliflozin/Pioglitazone and Dapagliflozin/Sitagliptin in people with Type 2 Diabetes, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metformin, Dapagliflozin/Pioglitazone and Dapagliflozin/Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2025to 1 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has voluntarily agreed to participate in this clinical trial.
- Adults over 19 years of age
- Diagnosed with type 2 diabetes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seocho District, 06591
About this study
Official 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Metformin, Dapagliflozin/Pioglitazone, Dapagliflozin/Sitagliptin
- Keywords
- type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
The dosage and dose frequency are maintained as they were before the screening.
Dapagliflozin/PioglitazoneDrug
Dapagliflozin 10mg/Pioglitazone 30mg QD
Dapagliflozin/SitagliptinDrug
Dapagliflozin 10mg/Sitagliptin 100mg QD
| Study group | Role | What they receive |
|---|---|---|
| Metformin + Dapagliflozin 10mg/Pioglitazone 30mg | Experimental | One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks. Receives: Drug: Metformin; Drug: Dapagliflozin/Pioglitazone |
| Metformin + Dapagliflozin 10mg/Sitagliptin 100mg | Active comparator | One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks. Receives: Drug: Metformin; Drug: Dapagliflozin/Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start11 Jun 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972732
- Sponsor's protocol ID
- BR-DPC-CT-401
- Acronym
- TELOS
- Status last verified
- Sep 2025
- First submitted
- 7 May 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06972732
- Acronym / sponsor ID
- TELOS / BR-DPC-CT-401
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin + Dapagliflozin 10mg/Pioglitazone 30mg | Experimental | Drug: 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 100mg | Active comparator | Drug: Metformin, Drug: Dapagliflozin/SitagliptinOne tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has voluntarily agreed to participate in this clinical trial.
- Adults over 19 years of age
- Diagnosed with type 2 diabetes
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminThe dosage and dose frequency are maintained as they were before the screening. | Drug | Metformin + Dapagliflozin 10mg/Pioglitazone 30mg, Metformin + Dapagliflozin 10mg/Sitagliptin 100mg |
| Dapagliflozin/PioglitazoneDapagliflozin 10mg/Pioglitazone 30mg QD | Drug | Metformin + Dapagliflozin 10mg/Pioglitazone 30mg |
| Dapagliflozin/SitagliptinDapagliflozin 10mg/Sitagliptin 100mg QD | Drug | Metformin + Dapagliflozin 10mg/Sitagliptin 100mg |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin, Dapagliflozin/Pioglitazone and Dapagliflozin/Sitagliptin in people with Type 2 Diabetes, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oh (+82 2-708-8000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (%) change at 24 weeks compared to the baseline (Visit 2) (time frame: From baseline to end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.