ASCVD 환자 및 비환자의 심혈관 사건 예방을 위한 INcreTin 기반 치료법 (INTERCEPT-ASCVD) (INTERCEPT)
2026년 5월 9일 업데이트: Shirley Vichy Wang, Brigham and Women's Hospital
제2형 당뇨병 및 비만 환자에서 아테롬성 심혈관 질환 유무에 따른 심혈관 사건 예방에서 듀라글루타이드, 세마글루타이드, 티르제파타이드의 비교 효과.
연구자들은 무작위 대조 시험의 대규모 모방을 통해 실제 세계 데이터에 대한 경험적 증거 기반을 구축하고 있습니다.
연구자들의 목표는 어떤 유형의 임상 질문에 대해 실제 세계 데이터 분석을 신뢰할 수 있게 수행할 수 있는지, 그리고 그러한 연구를 어떻게 구현할 수 있는지 이해하는 것입니다.
연구 개요
상세 설명
이 연구는 Brigham and Women's Hospital, Harvard Medical School의 RCT-DUPLICATE(무작위 대조 시험 중복 연구: 역학 기법 적용) 이니셔티브(www.rctduplicate.org)의 일환으로 진행되는 비무작위, 비중재 연구입니다. 무작위 대조 시험(RCT)은 선택된 집단에서 현대 인크레틴 요법인 세마글루타이드와 티르제파타이드의 심혈관 이점을 입증했습니다. SUSTAIN-6(NCT01720446)과 SURPASS-CVOT(NCT04255433)은 높은 심혈관 위험이 있는 T2DM 환자에서 세마글루타이드와 티르제파타이드가 심혈관 사건을 감소시킨다는 것을 보여주었으며, 이러한 결과는 임상 실무 환경에서도 재현되었습니다(NCT06659744, NCT07088718).1-3 REWIND 시험(NCT01394952)은 둘라글루타이드의 유사한 심혈관 효능을 입증했으며, 기존 심혈관 질환이 있거나 없는 환자 모두에게 이점이 있음을 시사했습니다.4 이러한 발견은 현대 인크레틴 요법의 심혈관 이점이 일상적인 임상 실무에서 사용될 때 확립된 죽상동맥경화성 심혈관 질환(ASCVD)이 없는 개인에게까지 확장되는지에 대한 더 넓은 질문을 제기합니다.
이 질문에 답하기 위해, 표적 시험 모방 프레임워크를 사용한 이 비교 효과 연구는 2형 당뇨병(T2DM)과 과체중이 있는 개인(ASCVD 유무에 관계없이)에서 주요 심혈관 이상 사건(MACE)에 대한 인크레틴 요법인 둘라글루타이드, 세마글루타이드, 티르제파타이드와 시타글립틴(능동 비교제 위약 대리로 사용됨)의 효과를 평가할 것입니다.
표적 시험의 많은 특징을 의료 청구 데이터에서 직접 재현할 수 없지만, 결과, 노출, 포함/제외 기준을 포함한 주요 설계 특징의 측정은 표적 시험의 해당 특징을 대리하기 위해 설계되었습니다. 의료 청구 데이터에서 무작위 배정은 달성할 수 없지만, 표준 관행에 따라 측정된 공변량의 통계적 균형을 통해 대리되었습니다.
데이터베이스 분석은 3개의 미국 전국 청구 데이터베이스를 사용하여 수행되는 신규 사용자 능동 비교 연구로, 우리는 둘라글루타이드, 세마글루타이드, 티르제파타이드와 시타글립틴의 죽상동맥경화성 심혈관 사건 예방 효과를 비교할 것입니다.
연구 유형
관찰
등록 (추정된)
60000
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02120
- Brigham and Women's Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
해당 없음
샘플링 방법
비확률 샘플
연구 인구
2형 당뇨병(T2DM) 및 과체중이 있는 개인(ASCVD가 있거나 없는 경우).
설명
데이터베이스 분석은 3개의 미국 국가 청구 데이터베이스를 사용하여 수행되는 신규 사용자 활성 비교 연구로, 듀라글루타이드, 세마글루타이드, 티르제파타이드가 시타글립틴에 비해 죽상동맥경화성 심혈관 사건 예방에 미치는 효과를 비교합니다.
옵텀: 2014년 9월 18일부터 2025년 8월 31일까지의 적격 코호트 등록 기간. 마켓스캔: 2016년 10월 1일부터 2023년 10월 31일까지의 적격 코호트 등록 기간. 메디케어: 2014년 9월 18일부터 2020년 10월 31일까지의 적격 코호트 등록 기간.
ASCVD 보유 집단
포함 기준:
- ASCVD 병력(심근경색, 급성 관동맥 증후군, 안정/불안정 협심증, 관상동맥/기타 동맥 재관류 시술(수술적 또는 경피적), 허혈성 뇌졸중, 일과성 뇌허혈발작, 대동맥류, 말초동맥질환으로 정의됨)
- 체질량지수 >= 25.0kg/m2
- 제2형 당뇨병
제외 기준:
- 수질 갑상선암
- 제2형 다발성 내분비선종증
- 악성 종양
- 제1형 당뇨병 또는 이차성 당뇨병
- 말기 신장병 또는 투석
- 조절되지 않는 당뇨병성 망막병증 또는 황반병증
- 임신
- 비만 수술
- 프람린타이드, 주사용 세마글루타이드/티르제파타이드/듀라글루타이드를 제외한 GLP-1 수용체 작용제, 시타글립틴을 제외한 DPP4 억제제의 과거 사용
- 심혈관 사건 또는 중재 시술
- 두 연구 약물의 병용 사용
ASCVD 비보유 집단
포함 기준:
- 체질량지수 >=25.0kg/m2
- 제2형 당뇨병
제외 기준:
- ASCVD 병력(심근경색, 급성 관동맥 증후군, 안정/불안정 협심증, 관상동맥/기타 동맥 재관류 시술(수술적 또는 경피적), 허혈성 뇌졸중, 일과성 뇌허혈발작, 대동맥류, 말초동맥질환으로 정의됨)
- 수질 갑상선암
- 제2형 다발성 내분비선종증
- 악성 종양
- 제1형 당뇨병 또는 이차성 당뇨병
- 말기 신장병 또는 투석
- 조절되지 않는 당뇨병성 망막병증 또는 황반병증
- 임신
- 비만 수술
- 프람린타이드, 주사용 세마글루타이드/티르제파타이드/듀라글루타이드를 제외한 GLP-1 수용체 작용제, 시타글립틴을 제외한 DPP4 억제제의 과거 사용
- 두 연구 약물의 병용 사용
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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듀라글루타이드, 세마글루타이드 또는 티르제파타이드의 시작
노출 그룹.
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듀라글루타이드 투약 청구의 시작이 노출로 사용됩니다.
세마글루타이드 처방 청구 시작이 노출로 사용됩니다.
티르제파타이드 투여 청구의 시작이 노출로 사용됩니다.
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시타글립틴 투여 시작
참조 그룹.
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시타글립틴 처방 청구의 개시가 기준으로 사용됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite of myocardial infarction, stroke, or all-cause mortality (with ASCVD)
기간: 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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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
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Composite of myocardial infarction, or stroke (with ASCVD)
기간: 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.
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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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Composite of myocardial infarction, stroke, or all-cause mortality (without ASCVD)
기간: 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
|
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Composite of myocardial infarction, or stroke (without ASCVD)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Myocardial infarction (with ASCVD)
기간: 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)
기간: 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)
기간: 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.
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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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Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (with ASCVD)
기간: 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)
기간: 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)
기간: 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.
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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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Coronary revascularization (with ASCVD)
기간: 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)
기간: 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.
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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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Time to first hospitalization for any cause (with ASCVD)
기간: 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.
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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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Myocardial infarction (without ASCVD)
기간: 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.
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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 (without ASCVD)
기간: 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)
기간: 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)
기간: 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).
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hernia (with ASCVD)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
- 수석 연구원: Nils Kruger, MD, Brigham and Women's Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 27일
기본 완료 (추정된)
2026년 5월 22일
연구 완료 (추정된)
2026년 5월 22일
연구 등록 날짜
최초 제출
2026년 2월 11일
QC 기준을 충족하는 최초 제출
2026년 2월 11일
처음 게시됨 (실제)
2026년 2월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 9일
마지막으로 확인됨
2026년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2018P002966-INTERCEPT-ASCVD
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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