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New Triple Combination Therapy in Newly Diagnosed Type 2 Diabetes

3. juni 2026 opdateret af: Yanbing Li, Sun Yat-sen University

Combination Therapy With Tirzepatide, Empagliflozin and Pioglitazone Versus Standard Therapy in Newly Diagnosed Type 2 Diabetes: a Multi-center Randomized Controlled Trial

The goal of this clinical trial is to learn the efficacy of combination therapy with tirzepatide, empagliflozin and pioglitazone versus standard therapy in newly diagnosed type 2 diabetes. The main objectives to achieve are:

  1. To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM.
  2. To compare the effects on β-cell function and glycemic control of the triple combination therapy against standard therapy in patients newly diagnosed with T2DM Researchers will compare drug new triple combination therapy with tirzepatide, empagliflozin, and pioglitazone to standard therapy (metformin based treatment) to see if new triple combination therapy works better in achieving type 2 diabetes remission.

Participants will:

  1. Take new triple combination therapy or a standard therapy every day for 6 months
  2. Visit the clinic once every 0.5-1 month for checkups and tests
  3. Keep a diary of their fingertip blood glucose and adverse events

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

296

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • The First Affiliated Hospital of Sun Yat-sen University
        • 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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Male or female, 18 years≤age≤75 years at the time of signing informed consent.
  2. Newly diagnosed with type 2 diabetes, or diagnosed within 1 years according to the WHO diagnostic criteria.
  3. Individuals who had not received previous antidiabetic therapy, or had not received antidiabetic therapy within 3 months prior to screening, or had not received antidiabetic therapy for more than 3 consecutive months or a combined total of more than 3 months in the past 2 years.
  4. 6.5%≤HbA1c≤9.0% at screening confirmed by central laboratory analysis.
  5. BMI≥24 kg/m2.

Exclusion Criteria:

  1. Individuals with type 1 diabetes or special types of diabetes.
  2. Allergy or intolerance to investigational drugs.
  3. Estimated Glomerular Filtration Rate (eGFR) <20 mL/min/1.73 m².
  4. Individuals with heart failure in New York Heart Association [NYHA] class III or IV in the 6 months prior to randomization.
  5. History of bladder cancer or hematuria.
  6. History of Multiple Endocrine Neoplasia Type 2 (MEN 2) or relevant family history.
  7. History or family history of Medullary Thyroid Carcinoma (MTC), or susceptibility to MTC due to hereditary conditions.
  8. History of fasting blood glucose≥13.9 mmol/L or the necessity for insulin use due to severe infection, diabetic foot, etc.
  9. History of acute diabetic complications: including diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis.
  10. Severe diabetic microvascular complications: proliferative retinopathy, or urinary AER>300mg/g, or urinary protein positive, quantitative >0.5g/24h.
  11. Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy.
  12. Severe diabetic macrovascular complications: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack and/or peripheral arterial disease required for vascular intervention or amputation within the 12 months prior to screening.
  13. Blood pressure persistently higher than 180/110 mmHg and not controllable to ≤160/100 mmHg within 1 week.
  14. Alanine Aminotransferase (ALT) ≥2.5 times the upper normal limit, total bilirubin ≥1.5 times the upper normal limit.
  15. Hemoglobin <100g/L or requiring regular blood transfusion.
  16. Use of medicines potentially affecting blood glucose for more than 1 week cumulatively in the past 12 weeks, such as corticosteroids, growth hormone analogs, estrogen/progestogen, high-dose diuretics, antipsychotic drugs, etc.
  17. Participation in another trial involving medicine therapy within the past 3 months.
  18. Expected lifespan less than 2 years as per the investigator's clinical judgment, e.g., but not limited to malignancy.
  19. Pregnant or lactating females, or females of childbearing potential who cannot or are unwilling to use adequate contraception.
  20. Deemed unsuitable for participation in this clinical trial at the discretion of the investigator.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A (triple combination intensive therapy group)
Tirzepatide, empagliflozin, and pioglitazone treatment. 1) Initiate with Tirzepatide 2.5 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, adjust Tirzepatide to 5.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 3) After 1 month, adjust Tirzepatide to 7.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd. 4) After 1 month, adjust Tirzepatide to 10.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 5) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.
Medicin: Group A (triple combination intensive therapy group)
1) Initiate with Tirzepatide 2.5 mg once weekly (qw) + Empagliflozin 10 mg once daily (qd) + Pioglitazone 15 mg once daily (qd); 2) After 1 month, adjust Tirzepatide to 5.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 3) After 1 month, adjust Tirzepatide to 7.5 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd. 4) After 1 month, adjust Tirzepatide to 10.0 mg qw + Empagliflozin 20 mg qd + Pioglitazone 30 mg qd; 5) If blood glucose remains uncontrolled after 1 month, add basal insulin therapy.
Aktiv komparator: Group B (standard therapy group)
Metformin-based treatment is recommended when not contraindicated. 1) Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After 1 month, if blood glucose remains uncontrolled, add Tirzepatide 2.5 mg qw; 4) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 5.0 mg qw; 5) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 7.5 mg qw; 6) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 10.0 mg qw.
Medicin: Group B (standard therapy group)
1) Initiate with Metformin monotherapy, titrate to the target dose of 1000 mg twice daily (bid) within 1 month or to the maximum tolerated dose (if Metformin is not tolerated, switch to Linagliptin 5 mg qd); 2) After 1 month, if blood glucose is not controlled, add a second antidiabetic drug, Empagliflozin 20 mg qd; 3) After 1 month, if blood glucose remains uncontrolled, add Tirzepatide 2.5 mg qw; 4) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 5.0 mg qw; 5) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 7.5 mg qw; 6) After 1 month, if blood glucose remains uncontrolled, adjust Tirzepatide to 10.0 mg qw.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diabetisk remission
Tidsramme: 6 måneder efter ophør af medicin
Diabetisk remission efter 6 måneder efter ophør af medicin (procentdel af patienter med HBA1C <6,5% 6 måneder efter ophør af medicin)
6 måneder efter ophør af medicin

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diabetisk remission
Tidsramme: 3 og 12 måneder efter seponering af medicin
Diabetisk remission efter 3 og 12 måneder efter ophør af medicin og tidspunktet for diabetisk remission
3 og 12 måneder efter seponering af medicin
EQ-5D-5L-spørgeskemaer, livskvalitet
Tidsramme: Ved baseline, 6 måneders medicinbehandling og ved 3, 6 og 12 måneder efter seponering af medicin

EQ-5D-5L-spørgeskemaer, vurdering af livskvalitet. EQ-5D-5L består i det væsentlige af 2 sider: EQ-5D-beskrivende system og EQ Visual Analogue Scale (EQ VAS).

Det beskrivende system omfatter fem dimensioner: mobilitet, egenpleje, sædvanlige aktiviteter, smerte/ubehag og angst/depression. Hver dimension har 5 niveauer: ingen problemer, små problemer, moderate problemer, alvorlige problemer og ekstreme problemer.

EQ VAS registrerer patientens selvklassificerede helbred på en lodret visuel analog skala, hvor slutpunkterne er mærket 'det bedste helbred, du kan forestille dig' og 'det værste helbred, du kan forestille dig'. VAS kan bruges som et kvantitativt mål for sundhedsresultatet, der afspejler patientens egen vurdering.
Ved baseline, 6 måneders medicinbehandling og ved 3, 6 og 12 måneder efter seponering af medicin
Trinvise omkostninger pr. Ekstra remission
Tidsramme: 6 måneder efter ophør af medicin
Trinvise omkostninger pr. Ekstra remission efter 6 måneder efter ophør af medicin
6 måneder efter ophør af medicin
Tid inden for rækkevidde (TIR)
Tidsramme: Ved baseline, 6 måneders medicinbehandling, og 6 måneder efter seponering af medicin
Tid inden for målet blodsukkerområde (3.9-10.0 mmol/l)
Ved baseline, 6 måneders medicinbehandling, og 6 måneder efter seponering af medicin
Trinvise omkostninger pr. Yderligere forbedring i tid inden for rækkevidde (TIR)
Tidsramme: 6 måneders medicinbehandling og efter 6 måneder efter ophør af medicin
Trinvise omkostninger pr. Yderligere forbedring i tid inden for rækkevidde (TIR) ​​efter 6 måneders medicinbehandling og efter 6 måneder efter ophør af medicin
6 måneders medicinbehandling og efter 6 måneder efter ophør af medicin
Time required to achieve glycemic goal
Tidsramme: 6 months of medication
The time required to achieve glycemic goal(FBG <6.1mmol/L, 2h PPG <8.0mmol/L or HbA1c#6.5%)
6 months of medication
HbA1c
Tidsramme: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
HbA1c level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood glucose level
Tidsramme: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Fasting and 2-hour postprandial blood glucose level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood insulin level
Tidsramme: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Fasting and 2-hour postprandial insulin level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Blood C-peptide level
Tidsramme: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Fasting and 2-hour postprandial C-peptide level at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Pancreatic β-cell function
Tidsramme: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
HOMA-B at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Insulin resistance
Tidsramme: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
HOMA-IR at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Weight changes
Tidsramme: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Weight at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
Incremental cost per QALY gained
Tidsramme: At baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
Incremental cost per QALY gained, derived from EQ-5D-5L assessments at baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication
At baseline, at 6 months of medication treatment, and at 3, 6, and 12 months after discontinuation of medication

Samarbejdspartnere og efterforskere

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

Sponsor

Sun Yat-sen University

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 (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. juli 2031

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R21002

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Diabetes mellitus

Kliniske forsøg med Group A (triple combination intensive therapy group)

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