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Koreansk undersøgelse af sikkerhed og effektivitet af OAD -tredobbelt terapi i type 2 -diabetes (TRIO)

29. september 2026 opdateret af: Chong Kun Dang Pharmaceutical

En multicenter, potentiel, ikke-interventionel observationsundersøgelse for at evaluere sikkerheden og effektiviteten af ​​OAD-tredobbelt terapi hos koreanske type 2-diabetiske mellitus-patienter

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

10000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Soo Lim, M.D, Ph.D.
  • Telefonnummer: 82-2-6373-0773
  • E-mail: limsoo@snu.ac.kr

Studiesteder

  • Sydkorea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Sydkorea
        • Rekruttering
        • Seoul National University Bundang Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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:

  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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Metformin/DPP4i/SGLT2i

Metformin + DPP4i 2-drug combination plus one of the SGLT-2i class of drugs.
Medicin: SGLT2 inhibitor

SGLT2 inhibitor class of drugs

Medicin: DPP-4 inhibitor

DPP4 inhibitor class of drugs
Metformin/DPP4i/TZD

Metformin + DPP4i 2-drug combination plus one of the TZD class of drugs.
Medicin: DPP-4 inhibitor

DPP4 inhibitor class of drugs

Medicin: Thiazolidinedione

Thiazolidinedione class of drugs
Metformin/SGLT2i/DPP4i

Metformin + SGLT2i 2-drug combination plus one of the DPP4i class of drugs.
Medicin: SGLT2 inhibitor

SGLT2 inhibitor class of drugs

Medicin: DPP-4 inhibitor

DPP4 inhibitor class of drugs
Metformin/SGLT2i/TZD

Metformin + SGLT2i 2-drug combination plus one of the TZD class of drugs.
Medicin: SGLT2 inhibitor

SGLT2 inhibitor class of drugs

Medicin: Thiazolidinedione

Thiazolidinedione class of drugs

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety Evaluation of Triple Combination Therapy with SGLT-2i, DPP-4i, or TZD Class Drugs, Including Metformin
Tidsramme: 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.
Up to 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in HbA1c
Tidsramme: 3, 6, (9), 12, 18, and 24 months

Evaluation of HbA1c(%) Change Compared to Baseline in Each Combination Group
3, 6, (9), 12, 18, and 24 months
Changes in FPG
Tidsramme: 3, 6, (9), 12, 18, and 24 months

Evaluation of FPG(mg/dL) Change Compared to Baseline in Each Combination Group
3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 7.0%
Tidsramme: 3, 6, (9), 12, 18, and 24 months

Percentage of Subjects with HbA1c < 7.0% in Each Combination Group
3, 6, (9), 12, 18, and 24 months
Percentage of Subjects with HbA1c < 6.5%
Tidsramme: 3, 6, (9), 12, 18, and 24 months

Percentage of Subjects with HbA1c < 6.5% in Each Combination Group
3, 6, (9), 12, 18, and 24 months
Factors influencing HbA1c change at each time point in each combination group.
Tidsramme: 3, 6, (9), 12, 18, and 24 months

demographics, previous hypoglycemic medications, hypoglycemic medication components and doses, duration of hypoglycemic medication, duration of disease, comorbidities, concomitant medications, etc.
3, 6, (9), 12, 18, and 24 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Weight
Tidsramme: 3, 6, (9), 12, 18, 24 months

Changes in Weight(kg) Compared to Baseline in Each Combination Group
3, 6, (9), 12, 18, 24 months
Changes in waist circumference
Tidsramme: 12 and 24 months

Changes in waist circumference(cm) compared to Baseline in Each Combination Group
12 and 24 months
Changes in body composition(protein mass)
Tidsramme: 12 and 24 months

Change in total protein mass from baseline in each combination group, as measured using InBody 770 or a higher model.
12 and 24 months
Changes in body composition(protein mass)
Tidsramme: 12 and 24 months

Change in protein mass from baseline in each combination group, as measured using InBody 770 or a higher model.
12 and 24 months
Changes in body composition(body fat)
Tidsramme: 12 and 24 months

Change in body fat mass from baseline in each combination group, as measured using InBody 770 or a higher model.
12 and 24 months
Changes in body composition(mineral mass)
Tidsramme: 12 and 24 months

Change in mineral mass from baseline in each combination group, as measured using InBody 770 or a higher model.
12 and 24 months
Changes in Fatty Liver Index
Tidsramme: 6, 12, 18, and 24 months

Changes in Fatty Liver Index compared to Baseline in Each Combination Group
6, 12, 18, and 24 months
Changes in AST
Tidsramme: 6, 12, 18, and 24 months

Changes in AST(IU/L) Compared to Baseline in Each Combination Group
6, 12, 18, and 24 months
Changes in ALT
Tidsramme: 6, 12, 18, and 24 months

Changes in ALT(IU/L) Compared to Baseline in Each Combination Group
6, 12, 18, and 24 months
Changes Platelet Levels
Tidsramme: 6, 12, 18, and 24 months

Changes in Platelet(10^3/uL) Levels Compared to Baseline in Each Combination Group
6, 12, 18, and 24 months
Changes in Blood Lipid Levels(Total cholesterol, LDL-C, HDL-C, TG)
Tidsramme: 6, 12, 18, and 24 months

Change in Total cholesterol, LDL-C, HDL-C, TG(mg/dL) compared to Baseline in Each Combination Group
6, 12, 18, and 24 months
Changes in Insulin-Related Test Levels(HOMA-IR)
Tidsramme: 12 and 24 months

Changes in HOMA-IR compared to Baseline in Each Combination Group
12 and 24 months
Changes in Insulin-Related Test Levels(HOMA-β)
Tidsramme: 12 and 24 months

Changes in HOMA-β(%) compared to Baseline in Each Combination Group
12 and 24 months
Changes in eGFR
Tidsramme: 6, 12, 18, and 24 months

Changes in eGFR(mL/min/1.73m2) compared to Baseline in Each Combination Group
6, 12, 18, and 24 months
Changes in UACR
Tidsramme: 6, 12, 18, and 24 months

Changes in UACR(mg/g) compared to Baseline in Each Combination Group
6, 12, 18, and 24 months
Change in hsCRP
Tidsramme: 12 and 24 months

Change in hsCRP(mg/dL) compared to Baseline in Each Combination Group
12 and 24 months
Change in ProBNP(or NT-ProBNP)
Tidsramme: 12 and 24 months

Change in ProBNP(or NT-ProBNP)(pg/mL) compared to Baseline in Each Combination Group
12 and 24 months
Change in PP2 Compared to Baseline in Each Combination Group
Tidsramme: 3, 6, (9), 12, 18, and 24 months

Change in PP2(mg/dL) compared to Baseline in Each Combination Group.
3, 6, (9), 12, 18, and 24 months
Incidence Rate of Major Adverse Cardiovascular Events(MACE)
Tidsramme: 24 month

Incidence Rate of Major Adverse Cardiovascular Events(MACE) from Baseline to 24 Months for Each Combination Group
24 month
Incidence Rate of Diabetic Microvascular Events
Tidsramme: 24 month

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chong Kun Dang Pharmaceutical

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. januar 2024

Primær færdiggørelse (Anslået)

1. oktober 2028

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

30. juni 2024

Først indsendt, der opfyldte QC-kriterier

18. februar 2025

Først opslået (Faktiske)

20. februar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D141_01DM2303

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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