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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

9,901

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2011

Longer than P75 for phase_3

Geographic Reach

25 countries

300 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.1 years study duration

First Submitted

Initial submission to the registry

July 13, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed

7 days until next milestone

Study Start

First participant enrolled

July 22, 2011

Completed

7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 8, 2019

Completed

Last Updated

October 8, 2019

Status Verified

September 1, 2019

Enrollment Period

7.1 years

First QC Date

July 13, 2011

Results QC Date

August 9, 2019

Last Update Submit

September 18, 2019

Conditions

Cardiovascular Disease Diabetes Mellitus, Type 2

Keywords

Cardiovascular diseaseDiabetes MellitusDulaglutide

Outcome Measures

Primary Outcomes (1)

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)

Secondary Outcomes (5)

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
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
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
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
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
From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Study Arms (2)

1.5 mg Dulaglutide

EXPERIMENTAL

Administered once weekly, subcutaneously

Drug: Dulaglutide

Placebo

PLACEBO COMPARATOR

Administered once weekly, subcutaneously

Drug: Placebo

Interventions

DulaglutideDRUG

Administered subcutaneously

Also known as: LY2189265

1.5 mg Dulaglutide

PlaceboDRUG

Administered subcutaneously

Placebo

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (300)

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

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Pell City, Alabama, 35128, United States

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Phoenix, Arizona, 85012, United States

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Tucson, Arizona, 85723, United States

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Little Rock, Arkansas, 72205, United States

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Burlingame, California, 94010, United States

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Lakewood, California, 90712, United States

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Long Beach, California, 90822, United States

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Los Angeles, California, 90333, United States

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Northridge, California, 91325, United States

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San Diego, California, 92161, United States

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Waterbury, Connecticut, 06708, United States

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Washington D.C., District of Columbia, 20010, United States

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Brandon, Florida, 33511, United States

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Miami, Florida, 33125, United States

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Palm Harbor, Florida, 34684, United States

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Plant City, Florida, 33563, United States

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Port Charlotte, Florida, 33952, United States

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West Palm Beach, Florida, 33401, United States

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Winter Haven, Florida, 33880, United States

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Lawrenceville, Georgia, 30046, United States

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Honolulu, Hawaii, 96814, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40502, United States

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New Orleans, Louisiana, 70112, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55455, United States

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Columbia, Missouri, 65212, United States

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Kansas City, Missouri, 64128, United States

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St Louis, Missouri, 63106, United States

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Kalispell, Montana, 59901, United States

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Omaha, Nebraska, 68105, United States

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Camden, New Jersey, 08103, United States

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Fresh Meadows, New York, 11365, United States

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Rochester, New York, 14607, United States

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Westfield, New York, 14787, United States

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Morehead City, North Carolina, 28557, United States

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Columbus, Ohio, 43210, United States

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Portland, Oregon, 97239, United States

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Murrells Inlet, South Carolina, 29576, United States

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Memphis, Tennessee, 38104, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77030, United States

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Lubbock, Texas, 79423, United States

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Salt Lake City, Utah, 84124, United States

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Burke, Virginia, 22015, United States

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Charlottesville, Virginia, 22903, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23249, United States

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Salem, Virginia, 24153, United States

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Seattle, Washington, 98105, United States

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Bahía Blanca, 8000, Argentina

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Buenos Aires, C1119ACN, Argentina

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Cipolletti, 8324, Argentina

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Ciudad de Parana, E3100BBJ, Argentina

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Coronel Suárez, B7540GHD, Argentina

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Corrientes, 3400, Argentina

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Córdoba, 5000, Argentina

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Junín, B6000BHA, Argentina

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La Plata, B1900AVS, Argentina

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Mar del Plata, B7600FZN, Argentina

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Merlo, B1722COV, Argentina

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Quilmes, 1878, Argentina

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Rafaela Santa Fe, S2300MMA, Argentina

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Rosario, 2000, Argentina

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Salta, CP4400, Argentina

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San Miguel de Tucumán, T4000NIL, Argentina

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San Nicolás, 2900, Argentina

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Santa Fe, S2000FWO, Argentina

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Venado Tuerto, S2600, Argentina

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Villa María, X5900JKA, Argentina

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Zárate, 2800, Argentina

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St Leonards, New South Wales, 2065, Australia

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Milton, Queensland, 4064, Australia

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Elizabeth Vale, South Australia, 5112, Australia

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Clayton, Victoria, 3168, Australia

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Heidelberg Heights, Victoria, 3081, Australia

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Melbourne, Victoria, 3004, Australia

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Parkville, Victoria, 3050, Australia

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Nedlands, Western Australia, 6009, Australia

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Belo Horizonte, 30150240, Brazil

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Brasília, 70390903, Brazil

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Campina Grande do Sul, 83430000, Brazil

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Campinas, 13020421, Brazil

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Curitiba, 80010-030, Brazil

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Porto Alegre, 90110-270, Brazil

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Rio de Janeiro, 20211-340, Brazil

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Sao Jose Rio Preto, 15090-000, Brazil

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São Paulo, 04025-011, Brazil

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Uberaba, 38025-260, Brazil

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Votuporanga, 15500-003, Brazil

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Blagoevgrad, 2700, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1142, Bulgaria

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Calgary, Alberta, T3G 0B4, Canada

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Spruce Grove, Alberta, T7X 2V2, Canada

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Winnipeg, Manitoba, R2H 0R8, Canada

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Brampton, Ontario, L6S 0C9, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Cambridge, Ontario, N1R 7L6, Canada

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Etobicoke, Ontario, M9R 4E1, Canada

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Hamilton, Ontario, L8S 3Z5, Canada

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Kingston, Ontario, K7L 2V7, Canada

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London, Ontario, N6A 4V2, Canada

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Markham, Ontario, L6B 0P9, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Oshawa, Ontario, L1J 2K1, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Smiths Falls, Ontario, K7A 4W8, Canada

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Thornhill, Ontario, L4J1W3, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Fleurimont, Quebec, J1H 5N4, Canada

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Gatineau, Quebec, J8Y6S9, Canada

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Granby, Quebec, J2G 8Z9, Canada

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Laval, Quebec, H7T 2P5, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Québec, Quebec, G1L 3L5, Canada

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Québec, Quebec, G1N 4V3, Canada

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Saint-Laurent, Quebec, H4T 1Z9, Canada

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Sherbrooke, Quebec, J1H 4J6, Canada

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Esaskatoon, Saskatchewan, S7K 3H3, Canada

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Québec, G1V 4G5, Canada

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Osomo, Chile

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Providencia, 7500520, Chile

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Santiago, 2570017, Chile

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Temuco, 4781173, Chile

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Armenia, 63001, Colombia

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Barranquilla, 1569, Colombia

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Barrio Maridias, Colombia

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Bogotá, 80CO, Colombia

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Cartagena, 130010, Colombia

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El Espinal, Colombia

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Floridablanca, 68276, Colombia

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Manizales, Colombia

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Medellín, 5001, Colombia

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Pereira, Colombia

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Brno, 66250, Czechia

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Chomutov, 43002, Czechia

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Havířov, 73601, Czechia

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Jinočany, 25225, Czechia

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Ostrava, 70200, Czechia

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Prague, 181 00, Czechia

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Příbram, 261 01, Czechia

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Uherské Hradiště, 68601, Czechia

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Valašské Klobouky, 76601, Czechia

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Bad Oeynhausen, 32545, Germany

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Berlin, 13158, Germany

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Bochum, 44787, Germany

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Burg, 03096, Germany

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Dippoldiswalde, 01744, Germany

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Dresden, 01307, Germany

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Düsseldorf, 40210, Germany

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Essen, 45355, Germany

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Haag, 83527, Germany

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Ingelheim, 55218, Germany

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Künzing, 94550, Germany

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Leipzig, 04107, Germany

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Ludwigshafen, 67067, Germany

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Mainz, 55116, Germany

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Pirna, 01796, Germany

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Riesa, 01587, Germany

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Saarlouis, 66740, Germany

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Speyer, 67346, Germany

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Villingen-Schwenningen, 78048, Germany

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Balatonfüred, 8230, Hungary

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Budapest, 1125, Hungary

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Kaposvár, 7400, Hungary

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Kecskemét, 6000, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Nyíregyháza, 4400, Hungary

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Szekszárd, 7100, Hungary

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Székesfehérvár, 8000, Hungary

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Veszprém, 8200, Hungary

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Daugavpils, LV -5417, Latvia

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Jelgava, LV 3000, Latvia

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Liepāja, LV3401, Latvia

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Limbaži, LV-4001, Latvia

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Ogre, LV-5001, Latvia

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Riga, LV-1002, Latvia

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Tukums, LV-3101, Latvia

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Valmiera, LV4201, Latvia

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Kaunas, LT50184, Lithuania

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Klaipėda, LT94231, Lithuania

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Vilniuslt, LT03116, Lithuania

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Aguascalientes, 20234, Mexico

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Cuernavaca, 62250, Mexico

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Culiacán, 80020, Mexico

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Guadalajara, 44860, Mexico

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Mexico City, 06090, Mexico

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Monterrey, 64620, Mexico

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Querétaro, 76000, Mexico

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Tijuana, 22329, Mexico

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Tlalpan, 14000, Mexico

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Toluca, 50010, Mexico

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Veracruz, 91910, Mexico

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Auckland, 1640, New Zealand

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Beckenham, Christchurch, 8024, New Zealand

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Christchurch, 8011, New Zealand

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Dunedin, 9012, New Zealand

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Hastings, New Zealand

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Papamoa, 3118, New Zealand

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Roslyn, 4414, New Zealand

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Rotorua, 3010, New Zealand

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Tauranga, 3112, New Zealand

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Waitakere City, 0612, New Zealand

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Wellington, 6021, New Zealand

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Westown, 4310, New Zealand

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Bialystok, 15-435, Poland

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Poznan, 61-655, Poland

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Puławy, 24100, Poland

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Sobótka, 55050, Poland

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Warsaw, 03003, Poland

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Wroclaw, 50-127, Poland

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Łosice, 08200, Poland

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Bayamón, 00960, Puerto Rico

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Manatí, 00674, Puerto Rico

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San Juan, 00917-3104, Puerto Rico

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Alba Lulia, 510053, Romania

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Bacau, 600164, Romania

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Brasov, 500365, Romania

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Bucharest, 010507, Romania

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Cluj-Napoca, 400349, Romania

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Constanța, 900591, Romania

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Craiova, 200642, Romania

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Deva, 330084, Romania

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Galati, 800371, Romania

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Iași, 700111, Romania

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Maramures, 430123, Romania

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Oradea, 410169, Romania

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Piteşti, 110084, Romania

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Ploieşti, 100163, Romania

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Satu Mare, 440055, Romania

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Sibiu, 550245, Romania

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Timișoara, 300736, Romania

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Chelyabinsk, 454021, Russia

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Moscow, 123423, Russia

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Novosibirsk, 630087, Russia

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Saint Petersburg, 194156, Russia

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Smolensk, 214019, Russia

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Volgograd, 400138, Russia

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Benoni, 1500, South Africa

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Bloemfontein, 9301, South Africa

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Cape Town, 7925, South Africa

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Die Wilgers Ext 14, 0041, South Africa

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Durban, 4001, South Africa

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Grassy Park, 7941, South Africa

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Johannesburg, 2193, South Africa

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Lynnwood Ridge, 0040, South Africa

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Lyttleton, 0140, South Africa

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Parow, 7505, South Africa

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Rondebosch, 7700, South Africa

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Somerset West, 7130, South Africa

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Soweto, 2013, South Africa

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Tongaat, 4400, South Africa

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Worcester, 6850, South Africa

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Busan, 602-715, South Korea

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Daegu, 705-718, South Korea

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Goyang, 410-773, South Korea

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Guri-si, 471-701, South Korea

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Gwangju, 501-757, South Korea

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Seoul, 137-701, South Korea

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Alicante, 03450, Spain

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Alzira, 46600, Spain

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Badalona, 08916, Spain

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Barcelona, 08022, Spain

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Centelles, 08540, Spain

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Lleida, 25198, Spain

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Palma de Mallorca, 07198, Spain

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Segovia, 40002, Spain

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Seville, 41009, Spain

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Valencia, 46014, Spain

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Vic, 08500, Spain

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Aneby, 57893, Sweden

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Gothenburg, 41685, Sweden

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Härnösand, 87182, Sweden

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Köping, 73181, Sweden

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Ljungby, 341 82, Sweden

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Östersund, 83183, Sweden

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Skellefteå, 93186, Sweden

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Stockholm, 17176, Sweden

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Vaxjo, 35185, Sweden

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Vällingby, 16268, Sweden

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Kaohsiung Hsien, 833, Taiwan

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Sindian City, 23148, Taiwan

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Taichung, 404, Taiwan

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Bath, Avon, BA2 3HT, United Kingdom

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Middlesbrough, Cleveland, TS4 3BW, United Kingdom

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Hull, East Yorkshire, HU3 2RW, United Kingdom

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Oldham, Lancashire, OL1 2JH, United Kingdom

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Belfast, Northern Ireland, BT16 0TH, United Kingdom

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Ayr, Scotland, KA6 6DX, United Kingdom

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Dundee, Scotland, DD1 9SY, United Kingdom

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Edinburgh, Scotland, EH4 2XU, United Kingdom

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Inverness, Scotland, IV2 3JH, United Kingdom

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Sheffield, South Yorkshire, S5 7AU, United Kingdom

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Swansea, Wales, SA6 6NL, United Kingdom

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Antrim, BT412RL, United Kingdom

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Bath, BA1 2SR, United Kingdom

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Belfast, BT12 6BA, United Kingdom

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Londonderry, BT47 6SB, United Kingdom

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Related Publications (17)

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.
PMID: 39963952DERIVED
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.
PMID: 36897834DERIVED
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.
PMID: 36723445DERIVED
Gerstein HC, Ramasundarahettige C, Avezum A, Basile J, Conget I, Cushman WC, Dagenais GR, Franek E, Lakshmanan M, Lanas F, Leiter LA, Pogosova N, Probstfield J, Raubenheimer PJ, Riddle M, Shaw J, Sheu WH, Temelkova-Kurktschiev T, Turfanda I, Xavier D. A novel kidney disease index reflecting both the albumin-to-creatinine ratio and estimated glomerular filtration rate, predicted cardiovascular and kidney outcomes in type 2 diabetes. Cardiovasc Diabetol. 2022 Aug 22;21(1):158. doi: 10.1186/s12933-022-01594-6.
PMID: 35996147DERIVED
Franek E, Gerstein HC, Riddle MC, Nicolay C, Hickey A, Botros FT, Loo LS. Efficacy and safety outcomes of dulaglutide by baseline HbA1c: A post hoc analysis of the REWIND trial. Diabetes Obes Metab. 2022 Sep;24(9):1753-1761. doi: 10.1111/dom.14760. Epub 2022 May 30.
PMID: 35546279DERIVED
Cukierman-Yaffe T, Gerstein HC, Basile J, Bethel MA, Cardona-Munoz EG, Conget I, Dagenais G, Franek E, Hall S, Hancu N, Jansky P, Lakshmanan M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Probstfield J, Rao-Melacini P, Ramasundarahettige C, Raubenheimer PJ, Riddle MC, Ryden L, Shaw JE, Sheu WH, Temelkova-Kurktschiev T. Novel Indices of Cognitive Impairment and Incident Cardiovascular Outcomes in the REWIND Trial. J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3448-e3454. doi: 10.1210/clinem/dgac200.
PMID: 35446415DERIVED
Kwan AYM, Gerstein HC, Basile J, Xavier D, Maldonado JM, Raha S, Konig M. HbA1c Reduction in Dulaglutide-Treated Patients Irrespective of Duration of Diabetes, Microvascular Disease, and BMI: A Post Hoc Analysis From the REWIND Trial. Diabetes Care. 2022 Mar 1;45(3):547-554. doi: 10.2337/dc21-1160.
PMID: 35043140DERIVED
Konig M, Riddle MC, Colhoun HM, Branch KR, Atisso CM, Lakshmanan MC, Mody R, Raha S, Gerstein HC. Exploring potential mediators of the cardiovascular benefit of dulaglutide in type 2 diabetes patients in REWIND. Cardiovasc Diabetol. 2021 Sep 25;20(1):194. doi: 10.1186/s12933-021-01386-4.
PMID: 34563178DERIVED
Bajaj HS, Gerstein HC, Rao-Melacini P, Basile J, Colhoun H, Conget I, Cushman WC, Dagenais GR, Franek E, Hanefeld M, Keltai M, Lakshmanan M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Probstfield J, Raubenheimer P, Ryden L, Shaw JE, Sheu WH, Xavier D. Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial. Lancet Diabetes Endocrinol. 2021 Aug;9(8):484-490. doi: 10.1016/S2213-8587(21)00115-7. Epub 2021 Jun 18.
PMID: 34153269DERIVED
Riddle MC, Gerstein HC, Xavier D, Cushman WC, Leiter LA, Raubenheimer PJ, Atisso CM, Raha S, Varnado OJ, Konig M, Lakshmanan M, Franek E. Efficacy and Safety of Dulaglutide in Older Patients: A post hoc Analysis of the REWIND trial. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1345-1351. doi: 10.1210/clinem/dgab065.
PMID: 33537745DERIVED
Dagenais GR, Ryden L, Leiter LA, Lakshmanan M, Dyal L, Probstfield JL, Atisso CM, Shaw JE, Conget I, Cushman WC, Lopez-Jaramillo P, Lanas F, Munoz EGC, Pirags V, Pogosova N, Basile J, Sheu WHH, Temelkova-Kurktschiev T, Raubenheimer PJ, Keltai M, Hall S, Pais P, Colhoun HM, Riddle MC, Gerstein HC. Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis. Cardiovasc Diabetol. 2020 Nov 25;19(1):199. doi: 10.1186/s12933-020-01179-1.
PMID: 33239067DERIVED
Cukierman-Yaffe T, Gerstein HC, Colhoun HM, Diaz R, Garcia-Perez LE, Lakshmanan M, Bethel A, Xavier D, Probstfield J, Riddle MC, Ryden L, Atisso CM, Hall S, Rao-Melacini P, Basile J, Cushman WC, Franek E, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T. Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial. Lancet Neurol. 2020 Jul;19(7):582-590. doi: 10.1016/S1474-4422(20)30173-3.
PMID: 32562683DERIVED
Gerstein HC, Hart R, Colhoun HM, Diaz R, Lakshmanan M, Botros FT, Probstfield J, Riddle MC, Ryden L, Atisso CM, Dyal L, Hall S, Avezum A, Basile J, Conget I, Cushman WC, Hancu N, Hanefeld M, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Munoz EGC, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T. The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial. Lancet Diabetes Endocrinol. 2020 Feb;8(2):106-114. doi: 10.1016/S2213-8587(19)30423-1. Epub 2020 Jan 7.
PMID: 31924562DERIVED
Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.
PMID: 31189511DERIVED
Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Botros FT, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):131-138. doi: 10.1016/S0140-6736(19)31150-X. Epub 2019 Jun 9.
PMID: 31189509DERIVED
Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
PMID: 29693361DERIVED
Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riddle MC, Ryden L, Xavier D, Atisso CM, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona-Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw J, Sheu WH, Temelkova-Kurktschiev T; REWIND Trial Investigators. Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. Diabetes Obes Metab. 2018 Jan;20(1):42-49. doi: 10.1111/dom.13028. Epub 2017 Jul 14.
PMID: 28573765DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes Mellitus, Type 2Diabetes Mellitus

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 15, 2011

Study Start

July 22, 2011

Primary Completion

August 21, 2018

Study Completion

August 21, 2018

Last Updated

October 8, 2019

Results First Posted

October 8, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CL(4)HU(9)PR(3)LI(3)RU(6)ZA(15)ES(11)PL(7)AR(21)KR(6)TW(3)BU(3)CO(10)ME(11)RO(17)SE(10)GB(15)NZ(12)US(51)BR(11)AU(8)DE(19)CZ(9)LA(8)CA(28)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

1.5 mg Dulaglutide

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (300)

Related Publications (17)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations