INkretinové terapie pro prevenci kardiovaskulárních příhod u pacientů s ASCVD a bez ASCVD (INTERCEPT-ASCVD) (INTERCEPT)
9. května 2026 aktualizováno: Shirley Vichy Wang, Brigham and Women's Hospital
Srovnávací účinnost dulaglutidu, semaglutidu a tirzepatidu při prevenci kardiovaskulárních příhod u pacientů s diabetem 2. typu a obezitou s nebo bez aterosklerotického kardiovaskulárního onemocnění.
Výzkumníci budují empirickou důkazovou základnu pro data z reálné praxe prostřednictvím rozsáhlé emulace randomizovaných kontrolovaných studií.
Cílem výzkumníků je pochopit, pro jaké typy klinických otázek lze analýzy dat z reálné praxe provádět s důvěrou a jak takové studie implementovat.
Přehled studie
Postavení
Aktivní, ne nábor
Podmínky
Intervence / Léčba
Detailní popis
Toto je nerandomizovaná, neintervenční studie, která je součástí iniciativy Randomizované kontrolované studie duplikované pomocí prospektivních longitudinálních pojistných nároků: Aplikace technik epidemiologie (RCT-DUPLICATE) (www.rctduplicate.org) nemocnice Brigham and Women's Hospital, Harvard Medical School. Randomizované kontrolované studie (RCT) prokázaly kardiovaskulární přínosy moderních inkretinových terapií semaglutidu a tirzepatidu u vybraných populací. Studie SUSTAIN-6 (NCT01720446) a SURPASS-CVOT (NCT04255433) prokázaly snížení kardiovaskulárních příhod u semaglutidu a tirzepatidu u pacientů s T2DM s vysokým kardiovaskulárním rizikem, což bylo replikováno i v klinické praxi (NCT06659744, NCT07088718).1-3 Studie REWIND (NCT01394952) prokázala podobnou kardiovaskulární účinnost dulaglutidu a naznačila přínos jak u pacientů s předchozím kardiovaskulárním onemocněním, tak bez něj.4 Tyto zjištění vyvolávají širší otázku, zda se kardiovaskulární přínosy moderních inkretinových terapií vztahují i na jedince bez prokázaného aterosklerotického kardiovaskulárního onemocnění (ASCVD) při použití v běžné klinické praxi.
Pro zodpovězení této otázky tato srovnávací účinnostní studie využívající rámec emulace cílové studie vyhodnotí inkretinové terapie dulaglutid, semaglutid a tirzepatid ve srovnání se sitagliptinem (použitým jako aktivní komparátorový placebo proxy) na závažné nepříznivé kardiovaskulární příhody (MACE) u jedinců s diabetem 2. typu (T2DM) a nadváhou s nebo bez ASCVD.
Ačkoli mnoho prvků cílové studie nelze přímo replikovat v pojistných nárocích, měření klíčových konstrukčních prvků, včetně výsledků, expozic a kritérií zařazení/vyloučení, bylo navrženo tak, aby tyto prvky z cílové studie aproximovalo. Randomizace není v datech pojistných nároků dosažitelná, ale byla aproximována statistickou vyvážeností měřených kovariát podle standardní praxe.
Analýzy databáze budou studie nových uživatelů s aktivním komparátorem, provedené pomocí 3 národních databází pojistných nároků USA, kde porovnáme účinek dulaglutidu, semaglutidu a tirzepatidu versus sitagliptinu na prevenci aterosklerotických kardiovaskulárních příhod.
Typ studie
Pozorovací
Zápis (Odhadovaný)
60000
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02120
- Brigham and Women's Hospital
-
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
N/A
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Jedinci s T2DM a nadváhou s (nebo bez) ASCVD.
Popis
Analýzy databází budou studie s novými uživateli a aktivním srovnáním, provedené pomocí 3 národních databází pojištěnců ve Spojených státech, kde porovnáváme účinek dulaglutidu, semaglutidu a tirzepatidu oproti sitagliptinu na prevenci aterosklerotických kardiovaskulárních příhod.
Optum: Přípustné období vstupu do kohorty od 18. září 2014 do 31. srpna 2025. Marketscan: Přípustný vstup do kohorty od 1. října 2016 do 31. října 2023. Medicare: Přípustný vstup do kohorty od 18. září 2014 do 31. října 2020.
POPULACE S ATEROSKLEROTICKÝM KARDIOVASKULÁRNÍM ONEMOCNĚNÍM
Kriteria zařazení:
- Anamnéza aterosklerotického kardiovaskulárního onemocnění (definovaného jako infarkt myokardu, akutní koronární syndrom, stabilní/nesatbilní angina, chirurgický nebo perkutánní koronární/jiný arteriální revaskularizační výkon, ischemická cévní mozková příhoda, tranzitorní ischemická ataka, aneuryzma aorty, onemocnění periferních tepen)
- BMI >= 25,0 kg/m²
- Diabetes mellitus 2. typu
Kriteria vyloučení:
- Medulární karcinom štítné žlázy
- Syndrom mnohočetné endokrinní neoplazie typu 2
- Malignita
- Diabetes mellitus 1. typu nebo sekundární diabetes
- Terminální selhání ledvin nebo dialýza
- Nekontrolovaná diabetická retinopatie nebo makulopatie
- Těhotenství
- Bariatrická chirurgie
- Předchozí užívání pramlintidu nebo jakéhokoliv agonistů receptoru GLP-1 kromě injekčního semaglutidu/tirzepatidu/dulaglutidu, nebo jakéhokoliv inhibitoru DPP-4 kromě sitagliptinu
- Kardiovaskulární příhoda nebo intervence
- Současné užívání obou studijních léků
POPULACE BEZ ATEROSKLEROTICKÉHO KARDIOVASKULÁRNÍHO ONEMOCNĚNÍ
Kriteria zařazení:
- BMI >= 25,0 kg/m²
- Diabetes mellitus 2. typu
Kriteria vyloučení:
- Anamnéza aterosklerotického kardiovaskulárního onemocnění (definovaného jako infarkt myokardu, akutní koronární syndrom, stabilní/nesatbilní angina, chirurgický nebo perkutánní koronární/jiný arteriální revaskularizační výkon, ischemická cévní mozková příhoda, tranzitorní ischemická ataka, aneuryzma aorty, onemocnění periferních tepen)
- Medulární karcinom štítné žlázy
- Syndrom mnohočetné endokrinní neoplazie typu 2
- Malignita
- Diabetes mellitus 1. typu nebo sekundární diabetes
- Terminální selhání ledvin nebo dialýza
- Nekontrolovaná diabetická retinopatie nebo makulopatie
- Těhotenství
- Bariatrická chirurgie
- Předchozí užívání pramlintidu nebo jakéhokoliv agonistů receptoru GLP-1 kromě injekčního semaglutidu/tirzepatidu/dulaglutidu, nebo jakéhokoliv inhibitoru DPP-4 kromě sitagliptinu
- Současné užívání obou studijních léků
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Zahájení léčby dulaglutidem, semaglutidem nebo tirzepatidem
Expoziční skupina.
|
Jako expozice se používá zahájení vydávání dulaglutidu.
Jako expozice se používá zahájení uplatňování nároku na výdej semaglutidu.
Iniciace nároku na vydání tirzepatidu je použita jako expozice.
|
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Zahájení léčby sitagliptinem
Referenční skupina.
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Počátek nároku na vydání sitagliptinu je použit jako reference.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Composite of myocardial infarction, stroke, or all-cause mortality (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, or stroke (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction or stroke in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, or all-cause mortality (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, or stroke (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction or stroke in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Myocardial infarction (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of myocardial infarction in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Stroke (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of stroke in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
All-cause mortality (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of all-cause mortality in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Unstable angina (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of unstable angina in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Coronary revascularization (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of coronary revascularization in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Hospitalization for heart failure (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of hospitalization for heart failure in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Time to first hospitalization for any cause (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of time to first hospitalization for any cause in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Myocardial infarction (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of myocardial infarction in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Stroke (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of stroke in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
All-cause mortality (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of all-cause mortality in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure (without ASCVD).
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Unstable angina (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of unstable angina in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Coronary revascularization (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of coronary revascularization in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Hospitalization for heart failure (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the occurrence of hospitalization for heart failure in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Time to first hospitalization for any cause (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of time to first hospitalization for any cause in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Urinary tract infections (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of urinary tract infections in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Serious infections (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of serious infections in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Gastrointestinal adverse events (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of gastrointestinal adverse events in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Urinary tract infections (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of urinary tract infections in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Serious infections (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of serious infections in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Gastrointestinal adverse events (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of the safety outcome of gastrointestinal adverse events in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Hernia (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of negative control outcome hernia in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Lumbar radiculopathy (with ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of negative control outcome lumbar radiculopathy in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Hernia (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of negative control outcomes hernia in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
|
Lumbar radiculopathy (without ASCVD)
Časové okno: Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Hazard ratio of negative control outcomes lumbar radiculopathy in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.
|
Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
- Vrchní vyšetřovatel: Nils Kruger, MD, Brigham and Women's Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
27. ledna 2026
Primární dokončení (Odhadovaný)
22. května 2026
Dokončení studie (Odhadovaný)
22. května 2026
Termíny zápisu do studia
První předloženo
11. února 2026
První předloženo, které splnilo kritéria kontroly kvality
11. února 2026
První zveřejněno (Aktuální)
18. února 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. května 2026
Naposledy ověřeno
1. února 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Onemocnění endokrinního systému
- Poruchy výživy
- Metabolické choroby
- Nadměrná výživa
- Tělesná hmotnost
- Poruchy metabolismu glukózy
- Diabetes Mellitus
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Příznaky a symptomy
- Nadváha
- Diabetes mellitus, typ 2
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Azoly
- Glukagonský peptid-1 receptor
- Glukagonové peptidové receptory
- Receptory, G-protein-spojené
- Receptory, buněčný povrch
- Membránové proteiny
- Receptory, gastrointestinální hormon
- Receptory, peptid
- Pyraziny
- Triazoles
- Sitagliptin fosfát
- Tirzepatid
- Semaglutid
- Dulaglutide
Další identifikační čísla studie
- 2018P002966-INTERCEPT-ASCVD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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