Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
2026年7月8日 更新者：Shirley Vichy Wang、Brigham and Women's Hospital
Comparative Effectiveness of Semaglutide and Dulaglutide in Patients at Low, Moderate, and High Cardiovascular Risk With Type 2 Diabetes and Overweight
Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials.
The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
調査の概要
詳細な説明
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to assess the comparative effectiveness of semaglutide vs dulaglutide on cardiovascular outcomes in individuals typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes (T2DM) and overweight.
Although many features of the target trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the target trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.
The database study will be a new-user active-comparative study, conducted using 3 national United States claims databases, where the effect of semaglutide vs dulaglutide on the composite end point of all-cause mortality, myocardial infarction, or stroke will be assessed. Clinical guidelines during the study period recommended both injectable semaglutide and dulaglutide for the same indications of glucose lowering and cardiovascular risk reduction.
研究の種類
観察的
入学 (実際)
120000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02120
- Brigham and Women's Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Individuals typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with T2DM and overweight.
説明
Study Period:
Optum: Eligible cohort entry period between December 5, 2017 to November 30, 2025.
MarketScan: Eligible cohort entry period between December 5, 2017 to September 30, 2023.
Medicare: Eligible cohort entry period between December 5, 2017 to September 30, 2020.
Inclusion Criteria:
- Men or women aged 18 years or older
- History of myocardial infarction, stroke, any surgical or percutaneous revascularization procedure
- Use of antihypertensive or lipid-lowering drugs
- Coronary, carotid, or peripheral artery disease
- BMI greater than or equal to 25.0 mg/m2
- Type 2 diabetes
Exclusion Criteria:
- Medullary thyroid carcinoma
- MEN syndrome type 2
- Malignancy
- Type 1 diabetes
- Secondary diabetes
- End-stage renal disease or dialysis
- Uncontrolled diabetic retinopathy or maculopathy
- Pregnancy
- History of bariatric surgery
- Prior use of pramlintide or any GLP-1-RA, except semaglutide or dulaglutide
- Cardiovascular event or intervention in the last 7 days
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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デュラグルチド
参照グループ
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Initiation of dulaglutide described in electronic health records is used as the reference.
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Injectable semaglutide
Exposure group
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Initiation of injectable semaglutide described in electronic health records is used as the exposure.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Composite of all-cause mortality, myocardial infarction, or stroke.
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the composite of all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
|
Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
|
Hospitalization for heart failure
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the occurrence of heart failure hospitalizations in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
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Hospitalization for unstable angina
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on hospitalizations for unstable angina in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
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Coronary revascularization
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the occurrence of coronary revascularization in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Urinary tract infections
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the safety outcome of urinary tract infections in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
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Serious infections
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the safety outcome of serious infections in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
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Gastrointestinal adverse events
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the comparative effect of injectable semaglutide vs dulaglutide on the safety outcome of gastrointestinal adverse events in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
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1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
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Hernia
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the effect of injectable semaglutide vs dulaglutide on the negative control outcome of hernia in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
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Lumbar radiculopathy
時間枠：1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
To evaluate the effect of injectable semaglutide vs dulaglutide on the negative control outcome of lumbar radiculopathy in patients typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with type 2 diabetes and overweight.
|
1 day after cohort entry until outcome, disenrollment, end of study period, death, 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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Shirley Wang, PhD, ScM、Brigham and Women's Hospital
- 主任研究者：Nils Krüger, MD、Brigham and Women's Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月20日
一次修了 (実際)
2026年6月1日
研究の完了 (実際)
2026年6月1日
試験登録日
最初に提出
2026年5月23日
QC基準を満たした最初の提出物
2026年5月23日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月9日
QC基準を満たした最後の更新が送信されました
2026年7月8日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。