- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07635953
New Triple Combination Therapy in Newly Diagnosed Type 2 Diabetes
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:
- To compare efficacy of the triple combination therapy against standard therapy in achieving type 2 diabetes remission in patients newly diagnosed with T2DM.
- 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:
- Take new triple combination therapy or a standard therapy every day for 6 months
- Visit the clinic once every 0.5-1 month for checkups and tests
- Keep a diary of their fingertip blood glucose and adverse events
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Hai Li, MD, PHD
- Telefonnummer: +86-15920362668
- E-post: lihai8@mail.sysu.edu.cn
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510080
- The First Affiliated Hospital of Sun Yat-sen University
-
Kontakt:
- Hai Li, MD, PHD
- Telefonnummer: +86-15920362668
- E-post: lihai8@mail.sysu.edu.cn
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Male or female, 18 years≤age≤75 years at the time of signing informed consent.
- Newly diagnosed with type 2 diabetes, or diagnosed within 1 years according to the WHO diagnostic criteria.
- 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.
- 6.5%≤HbA1c≤9.0% at screening confirmed by central laboratory analysis.
- BMI≥24 kg/m2.
Exclusion Criteria:
- Individuals with type 1 diabetes or special types of diabetes.
- Allergy or intolerance to investigational drugs.
- Estimated Glomerular Filtration Rate (eGFR) <20 mL/min/1.73 m².
- Individuals with heart failure in New York Heart Association [NYHA] class III or IV in the 6 months prior to randomization.
- History of bladder cancer or hematuria.
- History of Multiple Endocrine Neoplasia Type 2 (MEN 2) or relevant family history.
- History or family history of Medullary Thyroid Carcinoma (MTC), or susceptibility to MTC due to hereditary conditions.
- History of fasting blood glucose≥13.9 mmol/L or the necessity for insulin use due to severe infection, diabetic foot, etc.
- History of acute diabetic complications: including diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis.
- Severe diabetic microvascular complications: proliferative retinopathy, or urinary AER>300mg/g, or urinary protein positive, quantitative >0.5g/24h.
- Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy.
- 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.
- Blood pressure persistently higher than 180/110 mmHg and not controllable to ≤160/100 mmHg within 1 week.
- Alanine Aminotransferase (ALT) ≥2.5 times the upper normal limit, total bilirubin ≥1.5 times the upper normal limit.
- Hemoglobin <100g/L or requiring regular blood transfusion.
- 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.
- Participation in another trial involving medicine therapy within the past 3 months.
- Expected lifespan less than 2 years as per the investigator's clinical judgment, e.g., but not limited to malignancy.
- Pregnant or lactating females, or females of childbearing potential who cannot or are unwilling to use adequate contraception.
- Deemed unsuitable for participation in this clinical trial at the discretion of the investigator.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diabetisk remission
Tidsram: 6 månader efter avbrott av medicinering
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Diabetisk remission vid 6 månader efter avbrott av medicinering (procent av patienterna med HBA1C <6,5% vid 6 månader efter avbrott av medicinering)
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6 månader efter avbrott av medicinering
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diabetisk remission
Tidsram: 3 och 12 månader efter avbrott av medicinering
|
Diabetisk remission vid 3 och 12 månader efter avbrott av medicinering och tiden för diabetisk remission
|
3 och 12 månader efter avbrott av medicinering
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|
EQ-5D-5L-frågeformulär, livskvalitet
Tidsram: Vid baslinjen, vid 6 månaders medicineringsbehandling och vid 3, 6 och 12 månader efter avbrott av medicinering
|
EQ-5D-5L-frågeformulär, bedömning av livskvalitet. EQ-5D-5L består i huvudsak av 2 sidor: EQ-5D-beskrivande systemet och den visuella analoga skalan (EQ VAS). Det beskrivande systemet omfattar fem dimensioner: rörlighet, egenvård, vanliga aktiviteter, smärta/obehag och ångest/depression. Varje dimension har 5 nivåer: inga problem, små problem, måttliga problem, allvarliga problem och extrema problem. EQ VAS registrerar patientens självklassade hälsa på en vertikal visuell analog skala där slutpunkterna är märkt "den bästa hälsan du kan föreställa dig" och "den värsta hälsan du kan föreställa dig". VAS kan användas som ett kvantitativt mått på hälsoutfall som återspeglar patientens egen bedömning. |
Vid baslinjen, vid 6 månaders medicineringsbehandling och vid 3, 6 och 12 månader efter avbrott av medicinering
|
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Inkrementell kostnad per ytterligare remission
Tidsram: 6 månader efter avbrott av medicinering
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Inkrementell kostnad per ytterligare remission vid 6 månader efter avbrott av medicinering
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6 månader efter avbrott av medicinering
|
|
Time In Range (TIR)
Tidsram: Vid baslinjen, vid 6 månaders medicineringsbehandling och 6 månader efter avbrott av medicinering
|
Tid inom målblodglukosområdet (3,9-10.0
mmol/l)
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Vid baslinjen, vid 6 månaders medicineringsbehandling och 6 månader efter avbrott av medicinering
|
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Inkrementell kostnad per ytterligare förbättring inom tid inom räckvidden (TIR)
Tidsram: 6 månaders medicineringsbehandling och 6 månader efter avbrott av medicinering
|
Inkrementell kostnad per ytterligare förbättring inom tid inom räckvidd (TIR) vid 6 månaders medicineringsbehandling och vid 6 månader efter avbrott av medicinering
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6 månaders medicineringsbehandling och 6 månader efter avbrott av medicinering
|
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Time required to achieve glycemic goal
Tidsram: 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
Tidsram: 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
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Blood glucose level
Tidsram: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
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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
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At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
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Blood insulin level
Tidsram: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
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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
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At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
|
Blood C-peptide level
Tidsram: 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
|
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Pancreatic β-cell function
Tidsram: At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
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HOMA-B at baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
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At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
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Insulin resistance
Tidsram: 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
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At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
|
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Weight changes
Tidsram: 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
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At baseline, at 6 months of medication, and at 3, 6, and 12 months after discontinuation of medication
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Incremental cost per QALY gained
Tidsram: 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
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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