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NCT Number: NCT06838286

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

A multicenter, prospective, non-interventional observation study to evaluate the safety and effectiveness of OAD triple therapy in Korean Type 2 diabetic mellitus patients.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location status: Recruiting

Location contact

Soo Lim, M.D, Ph.D.

CONTACT

[email protected]

1588-3369

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

SGLT2 inhibitor

Drug

SGLT2 inhibitor class of drugs

Thiazolidinedione

Drug

Thiazolidinedione class of drugs

DPP-4 inhibitor

Drug

DPP4 inhibitor class of drugs

Primary outcomes

  1. Evaluation of Incidence of Adverse events in Triple Combination Therapy Including Metformin with SGLT-2i, DPP-4i, or TZD Class Drugs.

    Time frame: 24 month

    Safety assessment of triple combination therapy with Metformin SGLT2i or DPP4i and TZD class drugs(All adverse events occurring after the date of registration).

Secondary outcomes

  1. Changes in HbA1c

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

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

  2. Changes in FPG

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

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

  3. Percentage of Subjects with HbA1c < 7.0%

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

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

  4. Percentage of Subjects with HbA1c < 6.5%

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

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

  5. Factors influencing HbA1c change at each endpoint for each combination group.

    Time frame: 24 month

    demographics, past hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc.

Other outcomes

  1. Changes in Weight

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

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

  2. Changes in waist circumference

    Time frame: 12 and 24 months

    Changes in waist circumference(cm) compared to Baseline in Each Combination Group (body composition in body water(L), protein(kg), minerals(kg), and body fat(kg))

  3. Changes in Fatty Liver Index

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

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

  4. Changes in AST

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

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

  5. Changes in ALT

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

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

  6. Changes Platelet Levels

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

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

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

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

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

  8. Changes in Insulin-Related Test Levels(HOMA-IR, HOMA-β)

    Time frame: 12 and 24 months

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

  9. Changes in eGFR

    Time frame: 12 and 24 months

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

  10. Changes in UACR

    Time frame: 12 and 24 months

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

  11. Change in hsCRP

    Time frame: 12 and 24 months

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

  12. Change in ProBNP(or NT-ProBNP)

    Time frame: 12 and 24 months

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

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

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

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

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

    Time frame: 24 month

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

  15. Incidence Rate of Diabetic Microvascular Events

    Time frame: 24 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Soo Lim, M.D, Ph.D.

CONTACT

[email protected]

82-2-6373-0773

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Acronym: TRIO

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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