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INcreTin-basierte thERapien zur Prävention kardiovaskulärer Ereignisse bei Patienten mit und ohne ASCVD (INTERCEPT-ASCVD) (INTERCEPT)

9. Mai 2026 aktualisiert von: Shirley Vichy Wang, Brigham and Women's Hospital

Vergleichende Wirksamkeit von Dulaglutid, Semaglutid und Tirzepatid bei der Prävention kardiovaskulärer Ereignisse bei Patienten mit Typ-2-Diabetes und Adipositas mit oder ohne atherosklerotische kardiovaskuläre Erkrankung.

Die Forscher bauen eine empirische Evidenzbasis für Real-World-Daten durch eine groß angelegte Emulation randomisierter kontrollierter Studien auf. Das Ziel der Forscher ist es zu verstehen, für welche Arten klinischer Fragen Real-World-Datenanalysen mit Zuversicht durchgeführt werden können und wie solche Studien umgesetzt werden sollen.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Dies ist eine nicht randomisierte, nicht interventionelle Studie, die Teil der Initiative Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) (www.rctduplicate.org) des Brigham and Women's Hospital der Harvard Medical School ist. Randomisierte kontrollierte Studien (RCTs) haben kardiovaskuläre Vorteile der modernen Incretin-Therapien Semaglutid und Tirzepatid in ausgewählten Populationen gezeigt. SUSTAIN-6 (NCT01720446) und SURPASS-CVOT (NCT04255433) zeigten eine Reduktion kardiovaskulärer Ereignisse mit Semaglutid und Tirzepatid bei Patienten mit T2DM und hohem kardiovaskulärem Risiko, Ergebnisse, die auch in klinischen Praxisumgebungen repliziert wurden (NCT06659744, NCT07088718).1-3 Die REWIND-Studie (NCT01394952) demonstrierte eine ähnliche kardiovaskuläre Wirksamkeit für Dulaglutid und deutete auf einen Nutzen sowohl bei Patienten mit als auch ohne vorangegangene kardiovaskuläre Erkrankung hin.4 Diese Ergebnisse werfen die breitere Frage auf, ob die kardiovaskulären Vorteile moderner Incretin-Therapien auf Personen ohne etablierte atherosklerotische kardiovaskuläre Erkrankung (ASCVD) bei Anwendung in der routinemäßigen klinischen Praxis ausgeweitet werden können.

Um diese Frage zu beantworten, wird diese vergleichende Wirksamkeitsstudie unter Verwendung eines Target-Trial-Emulations-Rahmens die Incretin-Therapien Dulaglutid, Semaglutid und Tirzepatid im Vergleich zu Sitagliptin (verwendet als aktiver Komparator-Placebo-Proxy) auf schwere unerwünschte kardiovaskuläre Ereignisse (MACE) bei Personen mit Typ-2-Diabetes (T2DM) und Übergewicht mit oder ohne ASCVD bewerten.

Obwohl viele Merkmale des Zielversuchs nicht direkt in Krankenversicherungsdaten repliziert werden können, wurden Messungen von Schlüsseldesignmerkmalen, einschließlich Endpunkten, Expositionen und Ein-/Ausschlusskriterien, so gestaltet, dass sie diese Merkmale des Zielversuchs approximieren. Randomisierung kann in Krankenversicherungsdaten nicht erreicht werden, wurde jedoch durch eine statistische Ausbalancierung gemessener Kovariaten gemäß Standardpraxis angenähert.

Die Datenbankanalysen werden neue Anwender aktive Vergleichsstudien sein, durchgeführt unter Verwendung von 3 nationalen US-Versicherungsdatenbanken, in denen wir die Wirkung von Dulaglutid, Semaglutid und Tirzepatid im Vergleich zu Sitagliptin auf die Prävention atherosklerotischer kardiovaskulärer Ereignisse vergleichen.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

60000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02120
        • Brigham and Women's Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

N/A

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Personen mit T2DM und Übergewicht mit (oder ohne) ASCVD.

Beschreibung

Die Datenbankanalysen werden als aktive Vergleichsstudien mit neuen Anwendern durchgeführt, wobei drei nationale US-Krankenversicherungsdatenbanken verwendet werden, um die Wirkung von Dulaglutid, Semaglutid und Tirzepatid im Vergleich zu Sitagliptin auf die Prävention atherosklerotischer kardiovaskulärer Ereignisse zu untersuchen.

Optum: Zulässiger Kohorteneintrittszeitraum vom 18. September 2014 bis 31. August 2025. Marketscan: Zulässiger Kohorteneintritt vom 1. Oktober 2016 bis 31. Oktober 2023. Medicare: Zulässiger Kohorteneintritt vom 18. September 2014 bis 31. Oktober 2020.

POPULATION MIT ASCVD

Einschlusskriterien:

  • Anamnese von ASCVD (definiert als MI, ACS, stabile/instabile Angina pectoris, chirurgische oder perkutane koronare/andere arterielle Revaskularisationsverfahren, ischämischer Schlaganfall, TIA, Aortenaneurysma, periphere arterielle Verschlusskrankheit)
  • BMI >= 25,0 kg/m²
  • Typ-2-Diabetes

Ausschlusskriterien:

  • Medulläres Schilddrüsenkarzinom
  • MEN-Syndrom Typ 2
  • Malignom
  • Typ-1-Diabetes oder sekundärer Diabetes
  • Terminales Nierenversagen oder Dialyse
  • Unkontrollierte diabetische Retinopathie oder Makulopathie
  • Schwangerschaft
  • Adipositaschirurgie
  • Frühere Anwendung von Pramlintid oder irgendeinem GLP-1RA außer injizierbarem Semaglutid/Tirzepatid/Dulaglutid oder irgendeinem DPP4i außer Sitagliptin
  • Kardiovaskuläres Ereignis oder Intervention
  • Gleichzeitige Anwendung beider Studienmedikamente

POPULATION OHNE ASCVD

Einschlusskriterien:

  • BMI >= 25,0 kg/m²
  • Typ-2-Diabetes

Ausschlusskriterien:

  • Anamnese von ASCVD (definiert als MI, ACS, stabile/instabile Angina pectoris, chirurgische oder perkutane koronare/andere arterielle Revaskularisationsverfahren, ischämischer Schlaganfall, TIA, Aortenaneurysma, periphere arterielle Verschlusskrankheit)
  • Medulläres Schilddrüsenkarzinom
  • MEN-Syndrom Typ 2
  • Malignom
  • Typ-1-Diabetes oder sekundärer Diabetes
  • Terminales Nierenversagen oder Dialyse
  • Unkontrollierte diabetische Retinopathie oder Makulopathie
  • Schwangerschaft
  • Adipositaschirurgie
  • Frühere Anwendung von Pramlintid oder irgendeinem GLP-1RA außer injizierbarem Semaglutid/Tirzepatid/Dulaglutid oder irgendeinem DPP4i außer Sitagliptin
  • Gleichzeitige Anwendung beider Studienmedikamente

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Initiierung von Dulaglutid, Semaglutid oder Tirzepatid
Expositionsgruppe.
Arzneimittel: Dulaglutide
Die Einleitung des Dulaglutid-Abgabeanspruchs wird als Exposition verwendet.
Arzneimittel: Semaglutide
Die Initiierung des Semaglutid-Abgabeanspruchs wird als Exposition verwendet.
Arzneimittel: Tirzepatide
Die Einleitung des Tirzepatid-Abgabevorgangs wird als Exposition verwendet.
Einleitung von Sitagliptin
Referenzgruppe.
Arzneimittel: Sitagliptin
Der Beginn der Sitagliptin-Abgabemeldung dient als Referenz.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Composite of myocardial infarction, stroke, or all-cause mortality (with ASCVD)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Myocardial infarction (with ASCVD)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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).
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hernia (with ASCVD)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Brigham and Women's Hospital

Ermittler

  • Hauptermittler: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
  • Hauptermittler: Nils Kruger, MD, Brigham and Women's Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Januar 2026

Primärer Abschluss (Geschätzt)

22. Mai 2026

Studienabschluss (Geschätzt)

22. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

11. Februar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Februar 2026

Zuerst gepostet (Tatsächlich)

18. Februar 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Mai 2026

Zuletzt verifiziert

1. Februar 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2018P002966-INTERCEPT-ASCVD

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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