Diabetes Mellitus, Type 2TRIONCT06838286
Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SGLT2 inhibitor, Thiazolidinedione and DPP-4 inhibitor
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2024to 31 Dec 2029
- Phase
- Observational
- 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
Study population: Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.
Who may be able to join
- Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
- Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
- 7.0% ≤ HbA1c < 10.0% based on laboratory tests performed within 4 weeks of enrollment.
- Voluntarily give written informed consent after being told about the study.
Who cannot join
- Patients with type 1 diabetes and secondary diabetes.
- Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
- Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
- End-stage renal disease and hemodialysis patients.
- diabetic ketoacidosis Patients.
- Pregnant and lactating women.
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- Patients who are contraindicated by any of the "Precautions for Use" in the license for the drug being administered during the study, given the observational nature of the study under routine practice.
- Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
- Anyone else deemed by the investigator to be unsuitable for participation in the study.
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
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Soo Lim, M.D, Ph.D., 1588-3369, limsoo@snu.ac.kr
About this study
Official title: A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Read the detailed description
The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin.
Participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.
The 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- SGLT2 inhibitor, Thiazolidinedione, DPP-4 inhibitor
- Keywords
- Type 2 diabetes mellitus, Korean patients, Observational study, OAD triple therapy
- 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.
SGLT2 inhibitorDrug
SGLT2 inhibitor class of drugs
ThiazolidinedioneDrug
Thiazolidinedione class of drugs
DPP-4 inhibitorDrug
DPP4 inhibitor class of drugs
| Study group | Role | What they receive |
|---|---|---|
| Metformin/DPP4i/SGLT2i | Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs. Receives: Drug: SGLT2 inhibitor; Drug: DPP-4 inhibitor | |
| Metformin/DPP4i/TZD | Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs. Receives: Drug: Thiazolidinedione; Drug: DPP-4 inhibitor | |
| Metformin/SGLT2i/DPP4i | Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs. Receives: Drug: SGLT2 inhibitor; Drug: DPP-4 inhibitor | |
| Metformin/SGLT2i/TZD | Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs. Receives: Drug: SGLT2 inhibitor; Drug: Thiazolidinedione |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin
Safety will be assessed based on all adverse events, laboratory test results, and vital signs collected after enrollment during the study period.
Measured: Up to 24 months
Secondary outcomes (5)
Changes in HbA1c
Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group
Measured: 3, 6, (9), 12, 18, and 24 months
Changes in FPG
Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group
Measured: 3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 7.0%
Percentage of Subjects with HbA1c < 7.0% in Each Combination Group
Measured: 3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 6.5%
Percentage of Subjects with HbA1c < 6.5% in Each Combination Group
Measured: 3, 6, (9), 12, 18, and 24 months
Factors influencing HbA1c change at each time point in each combination group.
demographics, previous hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc.
Measured: 3, 6, (9), 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start2 Jan 2024
- Primary completionOct 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838286
- Sponsor's protocol ID
- D141_01DM2303
- Acronym
- TRIO
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2024
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Non-interventional Observation Study to Evaluate the Safety and Effectiveness of OAD Triple Therapy in Korean Type 2 Diabetic Mellitus Patients
- ClinicalTrials.gov ID
- NCT06838286
- Acronym / sponsor ID
- TRIO / D141_01DM2303
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, Korean patients, Observational study, OAD triple therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Feb 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.
A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.
Detailed description
The study was designed as a multicenter, prospective, non-interventional, observational study in patients with type 2 diabetes mellitus who had inadequate glycemic control with conventional combination oral hypoglycemic agents including metformin.
Participants in this study will have type 2 diabetes mellitus with insufficient glycemic control on conventional combination therapy with a DPP-4i or SGLT2i oral hypoglycemic agent, including metformin, requiring the addition of one of the following: SGLT-2i, DPP-4i, or TZD.
The 3-drug combination therapy will be prescribed to subjects based on the medical judgment of the investigator based on the licensure of SGLT-2i, DPP-4i, or TZD(efficacy, dosing, precautions for use, etc.) in a real-world practice setting and all treatment and observation, including administration of medications and laboratory tests, will be based on the medical judgment of the investigator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin/DPP4i/SGLT2i | – | Drug: SGLT2 inhibitor, Drug: DPP-4 inhibitorMetformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs. |
| Metformin/DPP4i/TZD | – | Drug: Thiazolidinedione, Drug: DPP-4 inhibitorMetformin + DPP4i 2-drug combination plus one of the TZD class of drugs. |
| Metformin/SGLT2i/DPP4i | – | Drug: SGLT2 inhibitor, Drug: DPP-4 inhibitorMetformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs. |
| Metformin/SGLT2i/TZD | – | Drug: SGLT2 inhibitor, Drug: ThiazolidinedioneMetformin + SGLT2i 2-drug combination plus one of the TZD class of drugs. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
- Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
- 7.0% ≤ HbA1c < 10.0% based on laboratory tests performed within 4 weeks of enrollment.
- Voluntarily give written informed consent after being told about the study.
Key exclusion criteria (9 listed)
- Patients with type 1 diabetes and secondary diabetes.
- Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
- Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
- End-stage renal disease and hemodialysis patients.
- diabetic ketoacidosis Patients.
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 |
|---|---|---|
| SGLT2 inhibitorSGLT2 inhibitor class of drugs | Drug | Metformin/DPP4i/SGLT2i, Metformin/SGLT2i/DPP4i, Metformin/SGLT2i/TZD |
| ThiazolidinedioneThiazolidinedione class of drugs | Drug | Metformin/DPP4i/TZD, Metformin/SGLT2i/TZD |
| DPP-4 inhibitorDPP4 inhibitor class of drugs | Drug | Metformin/DPP4i/SGLT2i, Metformin/DPP4i/TZD, Metformin/SGLT2i/DPP4i |
Primary outcome
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin
Time frame: Up to 24 months
Safety will be assessed based on all adverse events, laboratory test results, and vital signs collected after enrollment during the study period.
5 secondary outcomes
Changes in HbA1c
Time frame: 3, 6, (9), 12, 18, and 24 months
Changes in FPG
Time frame: 3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 7.0%
Time frame: 3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 6.5%
Time frame: 3, 6, (9), 12, 18, and 24 months
Factors influencing HbA1c change at each time point in each combination group.
Time frame: 3, 6, (9), 12, 18, and 24 months
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 30 Sep 2026.
- 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?
An observational study of Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical 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 4 inclusion and 9 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 30 Sep 2026. 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.
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 Soo Lim, M.D, Ph.D. (82-2-6373-0773, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin (time frame: Up to 24 months). 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 30 Sep 2026.