Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

NCT ID: NCT01394952

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 9901 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-22
• Study Completion Date: 2018-08-21

Brief Summary

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.

Conditions

Cardiovascular Disease; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1.5 mg Dulaglutide

Administered once weekly, subcutaneously

Group Type: EXPERIMENTAL

Dulaglutide

Intervention Type: DRUG

Administered subcutaneously

Placebo

Administered once weekly, subcutaneously

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered subcutaneously

Interventions

Dulaglutide

Administered subcutaneously

Intervention Type: DRUG

Placebo

Administered subcutaneously

Intervention Type: DRUG

Other Intervention Names

LY2189265

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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• Completed or withdrawn from any study investigating dulaglutide

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Calgary, Alberta, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Cambridge, Ontario, Canada

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Etobicoke, Ontario, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Oakville, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Fleurimont, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Esaskatoon, Saskatchewan, Canada

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Québec, , Canada

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Osomo, , Chile

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Providencia, , Chile

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Santiago, , Chile

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Temuco, , Chile

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Armenia, , Colombia

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Barranquilla, , Colombia

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Barrio Maridias, , Colombia

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Bogotá, , Colombia

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Cartagena, , Colombia

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El Espinal, , Colombia

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Floridablanca, , Colombia

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Manizales, , Colombia

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Medellín, , Colombia

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Pereira, , Colombia

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Jinočany, , Czechia

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Ostrava, , Czechia

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Bad Oeynhausen, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Dippoldiswalde, , Germany

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Düsseldorf, , Germany

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Essen, , Germany

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Haag, , Germany

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Ingelheim, , Germany

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Künzing, , Germany

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Leipzig, , Germany

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Ludwigshafen, , Germany

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Mainz, , Germany

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Pirna, , Germany

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Riesa, , Germany

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Saarlouis, , Germany

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Speyer, , Germany

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Villingen-Schwenningen, , Germany

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Balatonfüred, , Hungary

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Budapest, , Hungary

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Veszprém, , Hungary

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Daugavpils, , Latvia

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Liepāja, , Latvia

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Limbaži, , Latvia

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Tukums, , Latvia

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Valmiera, , Latvia

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Vilniuslt, , Lithuania

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Aguascalientes, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Querétaro, , Mexico

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Tijuana, , Mexico

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Tlalpan, , Mexico

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Toluca, , Mexico

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Veracruz, , Mexico

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Auckland, , New Zealand

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Hastings, , New Zealand

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Bialystok, , Poland

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Poznan, , Poland

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Puławy, , Poland

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Sobótka, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Łosice, , Poland

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Constanța, , Romania

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Craiova, , Romania

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Iași, , Romania

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Maramures, , Romania

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Oradea, , Romania

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Piteşti, , Romania

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Ploieşti, , Romania

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Timișoara, , Romania

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Smolensk, , Russia

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Volgograd, , Russia

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Benoni, , South Africa

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Cape Town, , South Africa

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Die Wilgers Ext 14, , South Africa

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Goyang, , South Korea

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Gwangju, , South Korea

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Badalona, , Spain

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Barcelona, , Spain

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Centelles, , Spain

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Lleida, , Spain

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Palma de Mallorca, , Spain

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Segovia, , Spain

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Seville, , Spain

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Valencia, , Spain

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Vic, , Spain

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Aneby, , Sweden

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Gothenburg, , Sweden

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Härnösand, , Sweden

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Köping, , Sweden

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Ljungby, , Sweden

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Östersund, , Sweden

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Skellefteå, , Sweden

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Stockholm, , Sweden

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Vaxjo, , Sweden

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Vällingby, , Sweden

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Taichung, , Taiwan

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Hull, East Yorkshire, United Kingdom

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Belfast, Northern Ireland, United Kingdom

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Dundee, Scotland, United Kingdom

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Swansea, Wales, United Kingdom

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Antrim, , United Kingdom

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Bath, , United Kingdom

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Belfast, , United Kingdom

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Londonderry, , United Kingdom

Countries

United States; Argentina; Australia; Brazil; Bulgaria; Canada; Chile; Colombia; Czechia; Germany; Hungary; Latvia; Lithuania; Mexico; New Zealand; Poland; Puerto Rico; Romania; Russia; South Africa; South Korea; Spain; Sweden; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39963952 (View on PubMed)

Gerstein HC, Lee SF, Pare G, Bethel MA, Colhoun HM, Hoover A, Lakshmanan M, Lin Y, Pirro V, Qian HR, Ruotolo G, Ryden L, Wilson JM, Duffin KL. Biomarker Changes Associated With Both Dulaglutide and Cardiovascular Events in the REWIND Randomized Controlled Trial: A Nested Case-Control Post Hoc Analysis. Diabetes Care. 2023 May 1;46(5):1046-1051. doi: 10.2337/dc22-2397.

Reference Type: DERIVED

PMID: 36897834 (View on PubMed)

Ferrannini G, Maldonado JM, Raha S, Rao-Melacini P, Khatun R, Atisso C, Shurzinske L, Gerstein HC, Ryden L, Bethel MA. Gender differences in cardiovascular risk, treatment, and outcomes: a post hoc analysis from the REWIND trial. Scand Cardiovasc J. 2023 Dec;57(1):2166101. doi: 10.1080/14017431.2023.2166101.

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PMID: 36723445 (View on PubMed)

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Provided Documents

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Document Type: Statistical Analysis Plan

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Other Identifiers

H9X-MC-GBDJ

Identifier Type: OTHER

Identifier Source: secondary_id

13438

Identifier Type: -

Identifier Source: org_study_id