Cardiovascular DiseasePhase 3REWINDNCT01394952

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

A Phase 3 study testing Dulaglutide in people with Cardiovascular Disease and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 300 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Cardiovascular Disease, Diabetes Mellitus, Type 2
What is being tested?: Dulaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9,901 participants
Where: 300 sitesin 25 countries
Study dates: 22 Jul 2011to 21 Aug 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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Completed or withdrawn from any study investigating dulaglutide

Trial locations and contacts

300 sites in 25 countries.

Country

City, postcode or hospital

300 sites in 25 countries

United States51 sites

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.
Brandon, Florida, 33511
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Burke, Virginia, 22015
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Burlingame, California, 94010
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Camden, New Jersey, 08103
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Charlottesville, Virginia, 22903
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Columbia, Missouri, 65212
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Columbus, Ohio, 43210
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Dallas, Texas, 75246
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Detroit, Michigan, 48202
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Fresh Meadows, New York, 11365
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Honolulu, Hawaii, 96814
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Houston, Texas, 77030
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Kalispell, Montana, 59901
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Kansas City, Missouri, 64128
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Lakewood, California, 90712
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Lawrenceville, Georgia, 30046
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Lexington, Kentucky, 40502
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Little Rock, Arkansas, 72205
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Long Beach, California, 90822
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Los Angeles, California, 90333
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Lubbock, Texas, 79423
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Memphis, Tennessee, 38104
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Miami, Florida, 33125
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Minneapolis, Minnesota, 55455
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Mobile, Alabama, 36606
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Morehead City, North Carolina, 28557
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Murrells Inlet, South Carolina, 29576
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New Orleans, Louisiana, 70112
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Norfolk, Virginia, 23507
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Northridge, California, 91325
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Omaha, Nebraska, 68105
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Palm Harbor, Florida, 34684
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Pell City, Alabama, 35128
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Phoenix, Arizona, 85012
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Plant City, Florida, 33563
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Port Charlotte, Florida, 33952
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Portland, Oregon, 97239
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Richmond, Virginia, 23249
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Rochester, New York, 14607
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Salem, Virginia, 24153
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Salt Lake City, Utah, 84124
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San Diego, California, 92161
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Seattle, Washington, 98105
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St Louis, Missouri, 63106
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Topeka, Kansas, 66606
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Tucson, Arizona, 85723
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Washington D.C., District of Columbia, 20010
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Waterbury, Connecticut, 06708
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West Palm Beach, Florida, 33401
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Westfield, New York, 14787
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Winter Haven, Florida, 33880

Other trials in United States

Canada28 sites

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Brampton, Ontario, L6S 0C9
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Burlington, Ontario, L7M 4Y1
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Calgary, Alberta, T3G 0B4
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Cambridge, Ontario, N1R 7L6
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Esaskatoon, Saskatchewan, S7K 3H3
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Etobicoke, Ontario, M9R 4E1
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Fleurimont, Quebec, J1H 5N4
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Gatineau, Quebec, J8Y6S9
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Granby, Quebec, J2G 8Z9
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Hamilton, Ontario, L8S 3Z5
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Kingston, Ontario, K7L 2V7
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Laval, Quebec, H7T 2P5
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London, Ontario, N6A 4V2
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Markham, Ontario, L6B 0P9
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Montreal, Quebec, H3A 1A1
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Oakville, Ontario, L6H 3P1
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Oshawa, Ontario, L1J 2K1
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Ottawa, Ontario, K1H 1A2
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Québec, Quebec, G1L 3L5
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Québec, Quebec, G1N 4V3
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Québec, G1V 4G5
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Saint-Laurent, Quebec, H4T 1Z9
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Sherbrooke, Quebec, J1H 4J6
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Smiths Falls, Ontario, K7A 4W8
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Spruce Grove, Alberta, T7X 2V2
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Thornhill, Ontario, L4J1W3
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Toronto, Ontario, M4N 3M5
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Winnipeg, Manitoba, R2H 0R8

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Argentina21 sites

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Bahía Blanca, 8000
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Buenos Aires, C1119ACN
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Cipolletti, 8324
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Ciudad de Parana, E3100BBJ
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Córdoba, 5000
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Coronel Suárez, B7540GHD
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Corrientes, 3400
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Junín, B6000BHA
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La Plata, B1900AVS
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Mar del Plata, B7600FZN
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Merlo, B1722COV
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Quilmes, 1878
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Rafaela Santa Fe, S2300MMA
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Rosario, 2000
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Salta, CP4400
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San Miguel de Tucumán, T4000NIL
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San Nicolás, 2900
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Santa Fe, S2000FWO
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Venado Tuerto, S2600
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Villa María, X5900JKA
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Zárate, 2800

Other trials in Argentina

Germany19 sites

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Bad Oeynhausen, 32545
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Berlin, 13158
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Bochum, 44787
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Burg, 03096
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Dippoldiswalde, 01744
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Dresden, 01307
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Düsseldorf, 40210
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Essen, 45355
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Haag, 83527
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Ingelheim, 55218
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Künzing, 94550
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Leipzig, 04107
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Ludwigshafen, 67067
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Mainz, 55116
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Pirna, 01796
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Riesa, 01587
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Saarlouis, 66740
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Speyer, 67346
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Villingen-Schwenningen, 78048

Other trials in Germany

Romania17 sites

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Alba Lulia, 510053
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Bacau, 600164
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Brasov, 500365
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Bucharest, 010507
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Cluj-Napoca, 400349
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Constanța, 900591
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Craiova, 200642
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Deva, 330084
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Galati, 800371
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Iași, 700111
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Maramures, 430123
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Oradea, 410169
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Piteşti, 110084
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Ploieşti, 100163
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Satu Mare, 440055
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Sibiu, 550245
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Timișoara, 300736

Other trials in Romania

South Africa15 sites

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Benoni, 1500
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Bloemfontein, 9301
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Cape Town, 7925
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Die Wilgers Ext 14, 0041
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Durban, 4001
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Grassy Park, 7941
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Johannesburg, 2193
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Lynnwood Ridge, 0040
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Lyttleton, 0140
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Parow, 7505
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Rondebosch, 7700
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Somerset West, 7130
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Soweto, 2013
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Tongaat, 4400
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Worcester, 6850

Other trials in South Africa

United Kingdom15 sites

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Antrim, BT412RL
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Ayr, Scotland, KA6 6DX
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Bath, Avon, BA2 3HT
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Bath, BA1 2SR
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Belfast, Northern Ireland, BT16 0TH
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Belfast, BT12 6BA
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Dundee, Scotland, DD1 9SY
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Edinburgh, Scotland, EH4 2XU
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Hull, East Yorkshire, HU3 2RW
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Inverness, Scotland, IV2 3JH
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Londonderry, BT47 6SB
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Middlesbrough, Cleveland, TS4 3BW
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Oldham, Lancashire, OL1 2JH
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Sheffield, South Yorkshire, S5 7AU
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Swansea, Wales, SA6 6NL

Other trials in United Kingdom

New Zealand12 sites

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Auckland, 1640
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Beckenham, Christchurch, 8024
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Christchurch, 8011
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Dunedin, 9012
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Hastings
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Papamoa, 3118
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Roslyn, 4414
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Rotorua, 3010
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Tauranga, 3112
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Waitakere City, 0612
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Wellington, 6021
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Westown, 4310

Other trials in New Zealand

Brazil11 sites

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Belo Horizonte, 30150240
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Brasília, 70390903
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Campina Grande do Sul, 83430000
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Campinas, 13020421
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Curitiba, 80010-030
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Porto Alegre, 90110-270
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Rio de Janeiro, 20211-340
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Sao Jose Rio Preto, 15090-000
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São Paulo, 04025-011
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Uberaba, 38025-260
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Votuporanga, 15500-003

Other trials in Brazil

Mexico11 sites

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Aguascalientes, 20234
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Cuernavaca, 62250
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Culiacán, 80020
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Guadalajara, 44860
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Mexico City, 06090
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Monterrey, 64620
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Querétaro, 76000
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Tijuana, 22329
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Tlalpan, 14000
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Toluca, 50010
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Veracruz, 91910

Other trials in Mexico

Spain11 sites

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Alicante, 03450
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Alzira, 46600
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Badalona, 08916
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Barcelona, 08022
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Centelles, 08540
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Lleida, 25198
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Palma de Mallorca, 07198
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Segovia, 40002
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Seville, 41009
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Valencia, 46014
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Vic, 08500

Other trials in Spain

Colombia10 sites

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Armenia, 63001
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Barranquilla, 1569
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Barrio Maridias
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Bogotá, 80CO
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Cartagena, 130010
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El Espinal
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Floridablanca, 68276
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Manizales
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Medellín, 5001
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Pereira

Other trials in Colombia

Sweden10 sites

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Aneby, 57893
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Gothenburg, 41685
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Härnösand, 87182
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Köping, 73181
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Ljungby, 341 82
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Östersund, 83183
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Skellefteå, 93186
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Stockholm, 17176
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Vällingby, 16268
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Vaxjo, 35185

Other trials in Sweden

Czechia9 sites

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Brno, 66250
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Chomutov, 43002
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Havířov, 73601
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Jinočany, 25225
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Ostrava, 70200
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Prague, 181 00
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Příbram, 261 01
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Uherské Hradiště, 68601
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Valašské Klobouky, 76601

Other trials in Czechia

Hungary9 sites

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Balatonfüred, 8230
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Budapest, 1125
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Kaposvár, 7400
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Kecskemét, 6000
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Mosonmagyaróvár, 9200
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Nyíregyháza, 4400
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Székesfehérvár, 8000
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Szekszárd, 7100
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Veszprém, 8200

Other trials in Hungary

Australia8 sites

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Clayton, Victoria, 3168
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Elizabeth Vale, South Australia, 5112
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Heidelberg Heights, Victoria, 3081
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Melbourne, Victoria, 3004
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Milton, Queensland, 4064
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Nedlands, Western Australia, 6009
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Parkville, Victoria, 3050
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St Leonards, New South Wales, 2065

Other trials in Australia

Latvia8 sites

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Daugavpils, LV -5417
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Jelgava, LV 3000
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Liepāja, LV3401
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Limbaži, LV-4001
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Ogre, LV-5001
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Riga, LV-1002
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Tukums, LV-3101
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Valmiera, LV4201

Other trials in Latvia

Poland7 sites

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Bialystok, 15-435
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Łosice, 08200
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Poznan, 61-655
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Puławy, 24100
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Sobótka, 55050
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Warsaw, 03003
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Wroclaw, 50-127

Other trials in Poland

Russia6 sites

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Chelyabinsk, 454021
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Moscow, 123423
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Novosibirsk, 630087
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Saint Petersburg, 194156
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Smolensk, 214019
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Volgograd, 400138

Other trials in Russia

South Korea6 sites

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Busan, 602-715
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Daegu, 705-718
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Goyang, 410-773
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Guri-si, 471-701
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Gwangju, 501-757
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Seoul, 137-701

Other trials in South Korea

Chile4 sites

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Osomo
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Providencia, 7500520
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Santiago, 2570017
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Temuco, 4781173

Other trials in Chile

Bulgaria3 sites

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Blagoevgrad, 2700
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Plovdiv, 4002
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Sofia, 1142

Other trials in Bulgaria

Lithuania3 sites

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Kaunas, LT50184
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Klaipėda, LT94231
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Vilniuslt, LT03116

Other trials in Lithuania

Puerto Rico3 sites

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Bayamón, 00960
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Manati, 00674
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San Juan, 00917-3104

Other trials in Puerto Rico

Taiwan3 sites

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Kaohsiung Hsien, 833
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Sindian City, 23148
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Taichung, 404

Other trials in Taiwan

About this study

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

Conditions: Cardiovascular Disease, Diabetes Mellitus, Type 2
Being tested: Dulaglutide, Placebo
Keywords: Cardiovascular disease, Diabetes Mellitus, Dulaglutide
Medical subject headings: Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DulaglutideDrug
Also called LY2189265
Administered subcutaneously
PlaceboDrug
Administered subcutaneously

Study groups in NCT01394952
Study group	Role	What they receive
1.5 mg Dulaglutide	Experimental	Administered once weekly, subcutaneously Receives: Drug: Dulaglutide
Placebo	Placebo comparator	Administered once weekly, subcutaneously Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 201121 Aug 2018

First posted15 Jul 2011 (estimated)
Study start22 Jul 2011
Primary completion21 Aug 2018
Study completion21 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 9,901 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01394952
Sponsor's protocol ID: 13438
Other IDs: H9X-MC-GBDJ
Acronym: REWIND
Status last verified: Sep 2019
First submitted: 13 Jul 2011
Last updated: 8 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Publications

Wilson JM, Dage JL, Qian HR, Irelan CL, Crowder HS, Duffin KL, Mintun M, Brooks DA, Gerstein HC, Bethel MA. Dulaglutide and neurodegeneration biomarkers: REWIND post hoc analysis. Alzheimers Dement. 2026 Apr;22(4):e71391. doi: 10.1002/alz.71391.
PubMed 41988866
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.
PubMed 39963952
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.
PubMed 36897834
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.
PubMed 36723445
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.
PubMed 35996147
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.
PubMed 35546279
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.
PubMed 35446415
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.
PubMed 35043140
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.
PubMed 34563178
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.
PubMed 34153269
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.
PubMed 33537745
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.
PubMed 33239067
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.
PubMed 32562683
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.
PubMed 31924562
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.
PubMed 31189511

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
ClinicalTrials.gov ID: NCT01394952
Acronym / sponsor ID: REWIND / 13438
Conditions: Cardiovascular Disease, Diabetes Mellitus, Type 2
Keywords: Cardiovascular disease, Diabetes Mellitus, Dulaglutide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 9,901 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 22 Jul 2011 (actual)
Primary completion: 21 Aug 2018 (actual)
Study completion: 21 Aug 2018 (actual)
First posted: 15 Jul 2011 (estimated)
Results: Posted 8 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1.5 mg Dulaglutide	Experimental	Drug: DulaglutideAdministered once weekly, subcutaneously
Placebo	Placebo comparator	Drug: PlaceboAdministered once weekly, subcutaneously

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DulaglutideAlso: LY2189265Administered subcutaneously	Drug	1.5 mg Dulaglutide
PlaceboAdministered subcutaneously	Drug	Placebo

Primary outcome

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)
Time frame: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)
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.

5 secondary outcomes

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

Results and safety

Results posted to the registry on 8 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	4,952	4,935
Dulaglutide	4,949	4,932

Primary outcome: 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)

Time frame: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years). Count of participants. Unit: Participants

Measure	Placebo n = 4952	Dulaglutide n = 4949
Value	663	594

Placebo vs Dulaglutide: Hazard Ratio (HR): 0.88 (95.33% CI 0.79 to 0.99), p = 0.026, Regression, Cox

Population analysed: All randomized participants.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Randomization to Study Completion (Up to 7 Years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2,044 of 4,949 (41.3%)	3,363 of 4,949 (68%)	592 of 4,949
Dulaglutide	1,991 of 4,943 (40.3%)	3,574 of 4,943 (72.3%)	536 of 4,943

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41988866Wilson JM, Dage JL, Qian HR, Irelan CL, Crowder HS, Duffin KL, Mintun M, Brooks DA, Gerstein HC, Bethel MA. Dulaglutide and neurodegeneration biomarkers: REWIND post hoc analysis. Alzheimers Dement. 2026 Apr;22(4):e71391. doi: 10.1002/alz.71391.
Derived from this study: PubMed 39963952Natale 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.
Derived from this study: PubMed 36897834Gerstein 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.
Derived from this study: PubMed 36723445Ferrannini 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.
Derived from this study: PubMed 35996147Gerstein 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.
Derived from this study: PubMed 35546279Franek 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.
Derived from this study: PubMed 35446415Cukierman-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.
Derived from this study: PubMed 35043140Kwan 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.
Derived from this study: PubMed 34563178Konig 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.
Derived from this study: PubMed 34153269Bajaj 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.
Derived from this study: PubMed 33537745Riddle 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.
Derived from this study: PubMed 33239067Dagenais 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.
Individual participant dataSharing planned: Yes. Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

300 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dulaglutide in people with Cardiovascular Disease and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 300 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 300 sites in United States, Canada, Argentina, Germany, Romania and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01394952, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.