INcreTiini-pohjaiset hoitomuodot sydän- ja verisuonitapahtumien ehkäisemiseksi potilailla, joilla on ja joilla ei ole ASCVD:tä (INTERCEPT-ASCVD) (INTERCEPT)
lauantai 9. toukokuuta 2026 päivittänyt: Shirley Vichy Wang, Brigham and Women's Hospital
Dulaglutidin, semaglutidin ja tirzepatidin vertaileva teho sydän- ja verisuonitapahtumien ehkäisyssä tyypin 2 diabetesta ja lihavuutta sairastavilla potilailla, joilla on ateroskleroottinen sydän- ja verisuonitauti tai ilman sitä.
Tutkijat rakentavat empiiristä näyttöä reaalimaailman datalle suurimuotoisten satunnaistettujen kontrolloitujen kokeiden emulaatioiden avulla.
Tutkijoiden tavoitteena on ymmärtää, millaisille kliinisille kysymyksille reaalimaailman data-analyysit voidaan suorittaa luotettavasti ja kuinka tällaiset tutkimukset toteutetaan.
Tutkimuksen yleiskatsaus
Tila
Aktiivinen, ei rekrytointi
Interventio / Hoito
Yksityiskohtainen kuvaus
Tämä on satunnaistamaton, ei-interventionaalinen tutkimus, joka kuuluu Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) -aloitteeseen (www.rctduplicate.org) Brighamin ja naisten sairaalassa, Harvardin lääketieteellisessä korkeakoulussa. Satunnaistetut kontrolloidut kokeet (RCT) ovat osoittaneet modernien inkretiinihoitojen semaglutidin ja tirzepatidin sydän- ja verisuonihyödyt valituilla väestöryhmillä. SUSTAIN-6 (NCT01720446) ja SURPASS-CVOT (NCT04255433) osoittivat sydän- ja verisuonitapahtumien vähenemisen semaglutidilla ja tirzepatidilla korkean sydän- ja verisuoniriskin T2DM-potilailla, löydökset, jotka toistuivat myös kliinisissä käytännöissä (NCT06659744, NCT07088718).1-3 REWIND-kokeessa (NCT01394952) havaittiin samanlainen sydän- ja verisuonihyöty dulaglutidille ja viitattiin hyötyyn sekä potilailla, joilla on aiempaa sydän- ja verisuonitautia, että ilman sitä.4 Nämä löydökset herättävät laajemman kysymyksen siitä, ulottuvatko modernien inkretiinihoitojen sydän- ja verisuonihyödyt myös henkilöille, joilla ei ole vakiintunutta ateroskleroottista sydän- ja verisuonitautia (ASCVD), kun niitä käytetään rutiininomaisessa kliinisessä käytännössä.
Vastatakseen tähän kysymykseen, tämä vertaileva tehokkuustutkimus, joka käyttää kohdekokeen jäljitelmäkehystä, arvioi inkretiinihoitojen dulaglutidin, semaglutidin ja tirzepatidin vaikutusta vs sitagliptiniä (käytettynä aktiivisena vertailijana plaseboproxy) vakavissa haitallisissa sydän- ja verisuonitapahtumissa (MACE) tyypin 2 diabetesta (T2DM) ja ylipainoa sairastavilla henkilöillä, joilla on tai ei ole ASCVD:tä.
Vaikka monia kohdekokeen ominaisuuksia ei voida suoraan jäljitellä terveydenhuollon vaatimuksissa, keskeisten suunnittelun piirteiden mittaukset, mukaan lukien tulokset, altistumiset ja sisällytys/poissulkemiskriteerit, suunniteltiin edustamaan näitä piirteitä kohdekokeesta. Satunnaistamista ei voida saavuttaa terveydenhuollon vaatimustiedoissa, mutta sitä lähennettiin tilastollisella tasapainottelulla mitattujen kovariaattien mukaan standardikäytännön mukaisesti.
Tietokanta-analyysejä tehdään uusien käyttäjien aktiivisina vertailevina tutkimuksina käyttäen 3 Yhdysvaltojen kansallista vaatimustietokantaa, joissa vertailemme dulaglutidin, semaglutidin ja tirzepatidin vaikutusta vs sitagliptiniä ateroskleroottisten sydän- ja verisuonitapahtumien ehkäisyssä.
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Arvioitu)
60000
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02120
- Brigham and Women's Hospital
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei käytössä
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
Ylipainoiset tyypin 2 diabetesta sairastavat henkilöt, joilla on (tai ilman) ASCVD:tä.
Kuvaus
Tietokanta-analyysejä tehdään uusien käyttäjien aktiivisina vertailevina tutkimuksina kolmen Yhdysvaltojen kansallisen vaatimusrekisterin avulla, joissa vertailemme dulaglutidin, semaglutidin ja tirzepatidin vaikutusta sitagliptiiniiin verrattuna ateroskleroottisten sydän- ja verisuonitapahtumien ehkäisyssä.
Optum: Kelvollinen kohortin sisäänottokausi 18. syyskuuta 2014 – 31. elokuuta 2025. Marketscan: Kelvollinen kohortin sisäänotto 1. lokakuuta 2016 – 31. lokakuuta 2023. Medicare: Kelvollinen kohortin sisäänotto 18. syyskuuta 2014 – 31. lokakuuta 2020.
VÄESTÖ, JOLLA ON ASCVD
Ottokriteerit:
- ASCVD-tautihistoria (määritelty: sydäninfarkti, akuutti sepelvaltimotauti, vakaa/epävakaa angina pectoris, kirurginen tai pallolaajennusleikkaus sepelvaltimoiden/muiden valtimoiden uudelleenkanavointimenettely, iskeeminen aivohalvaus, TIA, aortan aneurysma, ääreisvaltimotauti)
- Painoindeksi >= 25,0 kg/m²
- Tyypin 2 diabetes
Poissulkemiskriteerit:
- Kilpirauhasen medullainen karsinooma
- MEN-oireyhtymä tyyppi 2
- Pahanlaatuinen kasvain
- Tyypin 1 diabetes tai sekundaarinen diabetes
- Loppuvaiheen munuaissairaus tai dialyysi
- Hallitsematon diabeteettinen retinopatia tai makulopatia
- Raskaus
- Bariatrinen kirurgia
- Aiempi pramlintidin käyttö, tai mikä tahansa GLP-1RA lukuun ottamatta injektoitavaa semaglutidia/tirzepatidia/dulaglutidia, tai mikä tahansa DPP4-estäjä lukuun ottamatta sitagliptiiniä
- Sydän- ja verisuonitapahtuma tai toimenpide
- Molempien tutkittavien lääkkeiden samanaikainen käyttö
VÄESTÖ ILMAN ASCVD:TÄ
Ottokriteerit:
- Painoindeksi >= 25,0 kg/m²
- Tyypin 2 diabetes
Poissulkemiskriteerit:
- ASCVD-tautihistoria (määritelty: sydäninfarkti, akuutti sepelvaltimotauti, vakaa/epävakaa angina pectoris, kirurginen tai pallolaajennusleikkaus sepelvaltimoiden/muiden valtimoiden uudelleenkanavointimenettely, iskeeminen aivohalvaus, TIA, aortan aneurysma, ääreisvaltimotauti)
- Kilpirauhasen medullainen karsinooma
- MEN-oireyhtymä tyyppi 2
- Pahanlaatuinen kasvain
- Tyypin 1 diabetes tai sekundaarinen diabetes
- Loppuvaiheen munuaissairaus tai dialyysi
- Hallitsematon diabeteettinen retinopatia tai makulopatia
- Raskaus
- Bariatrinen kirurgia
- Aiempi pramlintidin käyttö, tai mikä tahansa GLP-1RA lukuun ottamatta injektoitavaa semaglutidia/tirzepatidia/dulaglutidia, tai mikä tahansa DPP4-estäjä lukuun ottamatta sitagliptiiniä
- Molempien tutkittavien lääkkeiden samanaikainen käyttö
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
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Dulaglutidin, semaglutidin tai tirzepatidin aloittaminen
Altistumisryhmä.
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Dulaglutidin jakelun aloittamisen vaatimus käytetään altistumisena.
Semaglutidin lääkeannosteluvaatimuksen aloittaminen käytetään altistuksena.
Tirzepatide-lääkkeen myyntivaatimuksen aloittamista käytetään altistumisena.
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Sitagliptiinin aloittaminen
Vertailuryhmä.
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Sitagliptinin jakelun aloittaminen käytetään viitepisteenä.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Composite of myocardial infarction, stroke, or all-cause mortality (with ASCVD)
Aikaikkuna: 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.
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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)
Aikaikkuna: 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
|
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Composite of myocardial infarction, stroke, or all-cause mortality (without ASCVD)
Aikaikkuna: 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.
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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)
Aikaikkuna: 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.
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Myocardial infarction (with ASCVD)
Aikaikkuna: 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.
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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
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Stroke (with ASCVD)
Aikaikkuna: 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.
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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
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All-cause mortality (with ASCVD)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
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Unstable angina (with ASCVD)
Aikaikkuna: 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
|
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Coronary revascularization (with ASCVD)
Aikaikkuna: 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
|
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Hospitalization for heart failure (with ASCVD)
Aikaikkuna: 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)
Aikaikkuna: 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
|
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Myocardial infarction (without ASCVD)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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).
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
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Serious infections (with ASCVD)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Hernia (with ASCVD)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
- Päätutkija: Nils Kruger, MD, Brigham and Women's Hospital
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Tiistai 27. tammikuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Perjantai 22. toukokuuta 2026
Opintojen valmistuminen (Arvioitu)
Perjantai 22. toukokuuta 2026
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 11. helmikuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 11. helmikuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 18. helmikuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 13. toukokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Lauantai 9. toukokuuta 2026
Viimeksi vahvistettu
Sunnuntai 1. helmikuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Endokriinisen järjestelmän sairaudet
- Ravitsemushäiriöt
- Metaboliset sairaudet
- Yliravitsemus
- Kehon paino
- Glukoosiaineenvaihduntahäiriöt
- Diabetes mellitus
- Patologiset tilat, merkit ja oireet
- Ravitsemukselliset ja aineenvaihduntataudit
- Merkit ja oireet
- Ylipainoinen
- Diabetes mellitus, tyyppi 2
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Atsolit
- Glukagonin kaltainen peptidi-1-reseptori
- Glukagonin kaltaiset peptidireseptorit
- Reseptorit, G-proteiiniin kytketty
- Reseptorit, solun pinta
- Kalvoproteiinit
- Reseptorit, maha -suolikanavan hormoni
- Reseptorit, peptidi
- Pyratsiinit
- Triatsolit
- Sitagliptiinifosfaatti
- Tirzepatide
- semaglutidi
- dulaglutidi
Muut tutkimustunnusnumerot
- 2018P002966-INTERCEPT-ASCVD
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .