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RecruitingNCT06838286TRIOUpdated Sep 30, 2026

Korean Study on Safety and Effectiveness of OAD Triple Therapy in Type 2 Diabetes

An observational study in Diabetes Mellitus, Type 2, sponsored by Chong Kun Dang Pharmaceutical. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Chong Kun Dang Pharmaceutical · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
19 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Type 2 diabetes mellitus
  • Korean patients
  • Observational study
  • OAD triple therapy
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with type 2 diabetes mellitus whose glycemic control is inadequate on 2 oral hypoglycemic agents, including metformin.

Inclusion criteria

  1. Patients with type 2 diabetes who are 19 years of age or older at the time of enrollment.
  2. Continued DPP-4i or SGLT-2i oral hypoglycemic combination therapy with metformin for at least 8 weeks prior to enrollment.
  3. 7.0% ≤ HbA1c \< 10.0% based on laboratory tests performed within 4 weeks of enrollment.
  4. Voluntarily give written informed consent after being told about the study.

Exclusion criteria

Exclusion Criteria:

  1. Patients with type 1 diabetes and secondary diabetes.
  2. Patients receiving concomitant therapy with 3 or more oral hypoglycemic agents within 8 weeks of enrollment.
  3. Requiring treatment with insulin, GLP-1, etc. in addition to oral hypoglycemic agents during the study.
  4. End-stage renal disease and hemodialysis patients.
  5. diabetic ketoacidosis Patients.
  6. Pregnant and lactating women.
  7. 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.
  8. Patients with a history of hypersensitivity to the investigational drug or any of its components or excipients.
  9. Anyone else deemed by the investigator to be unsuitable for participation in the study.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Metformin/DPP4i/SGLT2i

    Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.

    Drug: SGLT2 inhibitor · Drug: DPP-4 inhibitor

  • Metformin/DPP4i/TZD

    Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.

    Drug: Thiazolidinedione · Drug: DPP-4 inhibitor

  • Metformin/SGLT2i/DPP4i

    Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.

    Drug: SGLT2 inhibitor · Drug: DPP-4 inhibitor

  • Metformin/SGLT2i/TZD

    Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.

    Drug: SGLT2 inhibitor · Drug: Thiazolidinedione

Interventions

  • DrugSGLT2 inhibitor

    SGLT2 inhibitor class of drugs

  • DrugThiazolidinedione

    Thiazolidinedione class of drugs

  • DrugDPP-4 inhibitor

    DPP4 inhibitor class of drugs

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 24 months

Secondary outcomes

  1. Changes in HbA1c

    Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group

    Time frame: 3, 6, (9), 12, 18, and 24 months

  2. Changes in FPG

    Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group

    Time frame: 3, 6, (9), 12, 18, and 24 months

  3. Percentage of Subjects with HbA1c < 7.0%

    Percentage of Subjects with HbA1c \< 7.0% in Each Combination Group

    Time frame: 3, 6, (9), 12, 18, and 24 months

  4. Percentage of Subjects with HbA1c < 6.5%

    Percentage of Subjects with HbA1c \< 6.5% in Each Combination Group

    Time frame: 3, 6, (9), 12, 18, and 24 months

  5. 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.

    Time frame: 3, 6, (9), 12, 18, and 24 months

Other outcomes

  1. Changes in Weight

    Changes in Weight(kg) Compared to Baseline in Each Combination Group

    Time frame: 3, 6, (9), 12, 18, 24 months

  2. Changes in waist circumference

    Changes in waist circumference(cm) compared to Baseline in Each Combination Group

    Time frame: 12 and 24 months

  3. Changes in body composition(protein mass)

    Change in total protein mass from baseline in each combination group, as measured using InBody 770 or a higher model.

    Time frame: 12 and 24 months

  4. Changes in body composition(protein mass)

    Change in protein mass from baseline in each combination group, as measured using InBody 770 or a higher model.

    Time frame: 12 and 24 months

  5. Changes in body composition(body fat)

    Change in body fat mass from baseline in each combination group, as measured using InBody 770 or a higher model.

    Time frame: 12 and 24 months

  6. Changes in body composition(mineral mass)

    Change in mineral mass from baseline in each combination group, as measured using InBody 770 or a higher model.

    Time frame: 12 and 24 months

  7. Changes in Fatty Liver Index

    Changes in Fatty Liver Index compared to Baseline in Each Combination Group

    Time frame: 6, 12, 18, and 24 months

  8. Changes in AST

    Changes in AST(IU/L) Compared to Baseline in Each Combination Group

    Time frame: 6, 12, 18, and 24 months

  9. Changes in ALT

    Changes in ALT(IU/L) Compared to Baseline in Each Combination Group

    Time frame: 6, 12, 18, and 24 months

  10. Changes Platelet Levels

    Changes in Platelet(10\^3/uL) Levels Compared to Baseline in Each Combination Group

    Time frame: 6, 12, 18, and 24 months

  11. Changes in Blood Lipid Levels(Total cholesterol, LDL-C, HDL-C, TG)

    Change in Total cholesterol, LDL-C, HDL-C, TG(mg/dL) compared to Baseline in Each Combination Group

    Time frame: 6, 12, 18, and 24 months

  12. Changes in Insulin-Related Test Levels(HOMA-IR)

    Changes in HOMA-IR compared to Baseline in Each Combination Group

    Time frame: 12 and 24 months

  13. Changes in Insulin-Related Test Levels(HOMA-β)

    Changes in HOMA-β(%) compared to Baseline in Each Combination Group

    Time frame: 12 and 24 months

  14. Changes in eGFR

    Changes in eGFR(mL/min/1.73m2) compared to Baseline in Each Combination Group

    Time frame: 6, 12, 18, and 24 months

  15. Changes in UACR

    Changes in UACR(mg/g) compared to Baseline in Each Combination Group

    Time frame: 6, 12, 18, and 24 months

  16. Change in hsCRP

    Change in hsCRP(mg/dL) compared to Baseline in Each Combination Group

    Time frame: 12 and 24 months

  17. Change in ProBNP(or NT-ProBNP)

    Change in ProBNP(or NT-ProBNP)(pg/mL) compared to Baseline in Each Combination Group

    Time frame: 12 and 24 months

  18. Change in PP2 Compared to Baseline in Each Combination Group

    Change in PP2(mg/dL) compared to Baseline in Each Combination Group.

    Time frame: 3, 6, (9), 12, 18, and 24 months

  19. Incidence Rate of Major Adverse Cardiovascular Events(MACE)

    Incidence Rate of Major Adverse Cardiovascular Events(MACE) from Baseline to 24 Months for Each Combination Group

    Time frame: 24 month

  20. Incidence Rate of Diabetic Microvascular Events

    Incidence Rate of Diabetic Microvascular Events from Baseline to 24 Months for Each Combination Group

    Time frame: 24 month

06

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do, South Korea
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06838286
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Feb 20, 2025
Start date
Jan 2, 2024
Primary completion
Oct 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 30, 2026

Study contacts

Soo Lim, M.D, Ph.D.
Contact
limsoo@snu.ac.kr
82-2-6373-0773

Oversight

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

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