治験レーダー

ベータ

治験レーダーAI 試験候補者または患者患者の介護者医療専門家バイオテックプロバイオテック投資家研究者その他
	治験 NCT01394952 (REWIND)（対象：心血管疾患、2型糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。

フィルター基準に一致する試験が1件見つかりました

タイル表示

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) 第III相・フェーズ3 9,901

完了

治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。

治験番号 NCT01394952 (REWIND) は治療の研究で、心血管疾患、2型糖尿病 を対象とした 第III相・フェーズ3 介入研究臨床試験 でした。現在は完了です。2011年7月22日に開始し、9,901 名の参加者 が参加しました。この試験はイーライリリーによって主導され、2018年8月21日 に完了しました。ClinicalTrials.gov からの最新更新日は 2019年10月8日 です。

概要

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.

公式タイトル

The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)

疾患名

心血管疾患2型糖尿病

刊行物

Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

その他の研究識別子

REWIND
13438
H9X-MC-GBDJ (その他の識別子) (Eli Lilly and Company)

NCT番号

NCT01394952

開始日

2011-07-22

最終更新日

2019-10-08

終了予定日

2018-08-21

目標参加者数

9,901

試験の種類

介入研究

治験の相・段階

第III相・フェーズ3

状況

完了

キーワード

Cardiovascular disease
Diabetes Mellitus
Dulaglutide

主目的

治療

割付方法

無作為化

介入モデル

並行割当

盲検化

二重盲検

群（アーム）／介入

参加グループ/群	介入/治療法
実験的1.5 mg Dulaglutide Administered once weekly, subcutaneously	Dulaglutide Administered subcutaneously
プラセボ対照薬Placebo Administered once weekly, subcutaneously	プラセボ Administered subcutaneously

試験は何を測定していますか？

主要評価項目

評価指標	指標の説明	時間枠
Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)	The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.	From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

副次評価項目

評価指標	指標の説明	時間枠
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.	From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)
Number of Participants Who Experienced an Event for Time to All-cause Mortality	The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.	From randomization to study completion (Median Follow-Up of 5.4 Years)
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint	The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.	From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)
Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit	The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.	From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina	Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.	From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

適格基準

対象年齢

成人, 高齢者

試験の最低年齢

50 Years

対象性別

全て

Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol)
Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone
On stable antihyperglycemic regimen for at least 3 months
Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors

Uncontrolled diabetes requiring immediate therapy
History of severe hypoglycemia in past year
Acute coronary or cerebrovascular event within past 2 months
Planned or anticipated revascularization procedure
History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder
Pregnancy or planned pregnancy during the trial period
Completed or withdrawn from any study investigating dulaglutide

イーライリリー

連絡先情報がありません。

300 25カ国の場所

アメリカ合衆国

Alabama

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mobile, Alabama, 36606, United States

Arizona

Arkansas

California

Connecticut

District of Columbia

Florida

Georgia

Hawaii

Kansas

Kentucky

Louisiana

Michigan

Minnesota

Missouri

Montana

Nebraska

New Jersey

New York

North Carolina

Ohio

Oregon

South Carolina

Tennessee

Texas

Utah

Virginia

Washington

アルゼンチン

オーストラリア

New South Wales

Queensland

South Australia

Victoria

Western Australia

ブラジル

ブルガリア

カナダ

Alberta

Manitoba

Ontario

Quebec

Saskatchewan

チリ

コロンビア

チェコ

ドイツ

ハンガリー

ラトビア

リトアニア

メキシコ

ニュージーランド

ポーランド

プエルトリコ

ルーマニア

ロシア連邦

南アフリカ

大韓民国

スペイン

スウェーデン

台湾

イギリス

Avon

Cleveland

East Yorkshire

Lancashire

Northern Ireland

Scotland

South Yorkshire

Wales

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) 第III相・フェーズ3 9,901

選択基準

除外基準