AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3AMPLITUDE-ONCT03496298

Effect of Efpeglenatide on Cardiovascular Outcomes

A Phase 3 study testing Efpeglenatide (SAR439977) in people with Type 2 Diabetes Mellitus, run by Sanofi at 353 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Efpeglenatide (SAR439977)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,076 participants
Where
353 sitesin 28 countries
Study dates
27 Apr 2018to 10 Dec 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • T2DM with glycosylated hemoglobin (HbA1c) greater than (>) 7 percentage.
  • Age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor.
  • Female participants agreed to follow contraceptive guidance.
  • Signed written informed consent.

Who cannot join

  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
  • History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening.
  • Personal or family history of medullary thyroid cancer.
  • Hypertension (with a systolic blood pressure >180 millimeters of Mercury [mmHg] and/or diastolic blood pressure >100 mmHg).
  • Hospitalization for hypertensive emergency within 3 months prior to randomization.
  • Planned coronary procedure or surgery after randomization.
Show all 12Show fewer
  • No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization.
  • Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study.
  • Treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening.
  • Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening.
  • Antihyperglycemic treatment had not been stable within 3 months prior to screening.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

353 sites in 28 countries.

353 sites in 28 countries

United States79 sites

  • Investigational Site Number 8400034

    Alexandria, Louisiana, 71301

  • Investigational Site Number 8400095

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 8400067

    Beaver, Pennsylvania, 15009-1957

  • Investigational Site Number 8400072

    Bend, Oregon, 97702

  • Investigational Site Number 8400022

    Beverly Hills, California, 90211

  • Investigational Site Number 8400071

    Billings, Montana, 59103

  • Investigational Site Number 8400070

    Chicago, Illinois, 60607

  • Investigational Site Number 8400031

    Columbus, Ohio, 43203

  • Investigational Site Number 8400065

    Concord, California, 94520

  • Investigational Site Number 8400055

    Corpus Christi, Texas, 78814

  • Investigational Site Number 8400036

    Crystal Lake, Illinois, 60012

  • Investigational Site Number 8400097

    Dallas, Texas, 75230

  • Investigational Site Number 8400088

    El Paso, Texas, 79935

  • Investigational Site Number 8400064

    Englewood, Colorado, 80113

  • Investigational Site Number 8400029

    Fargo, North Dakota, 58104

  • Investigational Site Number 8400001

    Flint, Michigan, 48504

  • Investigational Site Number 8400061

    Flint, Michigan, 48532-3447

  • Investigational Site Number 8400058

    Fort Worth, Texas, 76132

  • Investigational Site Number 8400014

    Gilbert, Arizona, 85295

  • Investigational Site Number 8400028

    Great Falls, Montana, 59405-4507

  • Investigational Site Number 8400060

    Greenbrae, California, 94904

  • Investigational Site Number 8400076

    Greenville, North Carolina, 27834-5704

  • Investigational Site Number 8400015

    Greer, South Carolina, 29651

  • Investigational Site Number 8400019

    Hamden, Connecticut, 06517

  • Investigational Site Number 8400091

    Hialeah, Florida, 33012

  • Investigational Site Number 8400040

    Hollywood, Florida, 33024

  • Investigational Site Number 8400069

    Houston, Texas, 77004

  • Investigational Site Number 8400089

    Houston, Texas, 77030

  • Investigational Site Number 8400073

    Hudson, Florida, 34667

  • Investigational Site Number 8400081

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 8400011

    Jacksonville, Florida, 32204

  • Investigational Site Number 8400017

    Jacksonville, Florida, 32204

  • Investigational Site Number 8400042

    Jacksonville, Florida, 32277

  • Investigational Site Number 8400086

    Kalispell, Montana, 59901

  • Investigational Site Number 8400037

    Las Vegas, Nevada, 89128

  • Investigational Site Number 8400084

    Long Beach, California, 90807

  • Investigational Site Number 8400078

    Lorain, Ohio, 44053

  • Investigational Site Number 8400002

    Los Gatos, California, 95032

  • Investigational Site Number 8400006

    Macon, Georgia, 31210-1359

  • Investigational Site Number 8400049

    Manitowoc, Wisconsin, 54220

  • Investigational Site Number 8400016

    Memphis, Tennessee, 38163

  • Investigational Site Number 8400027

    Miami, Florida, 33126

  • Investigational Site Number 8400051

    Miami, Florida, 33136

  • Investigational Site Number 8400079

    Monroe, Louisiana, 71203

  • Investigational Site Number 8400007

    Morehead City, North Carolina, 28557

  • Investigational Site Number 8400093

    Morehead City, North Carolina, 28557

  • Investigational Site Number 8400094

    Morganton, North Carolina, 28655

  • Investigational Site Number 8400063

    Murrells Inlet, South Carolina, 29576

  • Investigational Site Number 8400009

    Nashville, Tennessee, 37203

  • Investigational Site Number 8400030

    New Albany, Indiana, 46113

  • Investigational Site Number 8400013

    New Orleans, Louisiana, 70112

  • Investigational Site Number 8400041

    New Port Richey, Florida, 34652

  • Investigational Site Number 8400052

    Norfolk, Virginia, 23510

  • Investigational Site Number 8400085

    Northridge, California, 91325

  • Investigational Site Number 8400059

    Ormond Beach, Florida, 32174

  • Investigational Site Number 8400077

    Owensboro, Kentucky, 42303

  • Investigational Site Number 8400047

    Oxon Hill, Maryland, 20745

  • Investigational Site Number 8400043

    Paris, Kentucky, 40361

  • Investigational Site Number 8400096

    Philadelphia, Pennsylvania, 19107

  • Investigational Site Number 8400021

    Pittsburgh, Pennsylvania, 15212

  • Investigational Site Number 8400082

    Pomona, California, 91767

  • Investigational Site Number 8400044

    Rapid City, South Dakota, 57702

  • Investigational Site Number 8400087

    Raritan, New Jersey, 08869

  • Investigational Site Number 8400092

    Richmond, Texas, 77469

  • Investigational Site Number 8400008

    Roswell, Georgia, 30076

  • Investigational Site Number 8400025

    Sacramento, California, 95821

  • Investigational Site Number 8400024

    Saint Paul, Minnesota, 55102

  • Investigational Site Number 8400039

    Salt Lake City, Utah, 84102

  • Investigational Site Number 8400032

    Sheffield, Alabama, 35660

  • Investigational Site Number 8400045

    St Louis, Missouri, 63136

  • Investigational Site Number 8400056

    Staten Island, New York, 10301

  • Investigational Site Number 8400012

    Surprise, Arizona, 85374

  • Investigational Site Number 8400018

    The Bronx, New York, 00000

  • Investigational Site Number 8400074

    Topeka, Kansas, 66606

  • Investigational Site Number 8400010

    Troy, Michigan, 48085

  • Investigational Site Number 8400005

    Troy, Michigan, 48098

  • Investigational Site Number 8400046

    Tucson, Arizona, 85745

  • Investigational Site Number 8400033

    Waco, Texas, 76710

  • Investigational Site Number 8400023

    Waterbury, Connecticut, 06708-3346

Other trials in United States

Canada31 sites

  • Investigational Site Number 1240001

    Barrie, L4N 7L3

  • Investigational Site Number 1240002

    Brampton, L6S 0C6

  • Investigational Site Number 1240018

    Burlington, L7M 1K9

  • Investigational Site Number 1240021

    Burlington, L7R 1E2

  • Investigational Site Number 1240007

    Calgary, T2H 2G4

  • Investigational Site Number 1240020

    Calgary, T2V 4J2

  • Investigational Site Number 1240024

    Chicoutimi, G7H 7K9

  • Investigational Site Number 1240004

    Concord, L4K 4M2

  • Investigational Site Number 1240005

    Etobicoke, M9R 4E1

  • Investigational Site Number 1240022

    Greater Sudbury, P3E 4H5

  • Investigational Site Number 1240011

    Lévis, G6W 0M5

  • Investigational Site Number 1240025

    London, N5W 6A2

  • Investigational Site Number 1240028

    London, N6A 5R8

  • Investigational Site Number 1240029

    Mirabel, J7J 2K8

  • Investigational Site Number 1240008

    Montreal, H1M 1B1

  • Investigational Site Number 1240031

    Montreal, H1T 1C8

  • Investigational Site Number 1240014

    Montreal, H4A 2C6

  • Investigational Site Number 1240023

    Montreal, H4A 3T2

  • Investigational Site Number 1240017

    Montreal, H4N 2W2

  • Investigational Site Number 1240015

    Oakville, L6M 1M1

  • Investigational Site Number 1240012

    Oshawa, L1J 2K1

  • Investigational Site Number 1240030

    Ottawa, K2J 0V2

  • Investigational Site Number 1240027

    Peterborough, K9J 0B2

  • Investigational Site Number 1240016

    Pointe-Claire, H9R 4S3

  • Investigational Site Number 1240010

    Québec, G1N 4V3

  • Investigational Site Number 1240019

    Red Deer, T4N 6V7

  • Investigational Site Number 1240006

    Sherbrooke, J1L 0H8

  • Investigational Site Number 1240013

    Toronto, M4G 3E8

  • Investigational Site Number 1240003

    Vancouver, V5Y 3W2

  • Investigational Site Number 1240026

    Victoria, V8V 4A1

  • Investigational Site Number 1240009

    Victoriaville, G6P 6P6

Other trials in Canada

Argentina18 sites

  • Investigational Site Number 0320009

    Buenos Aires, 1430

  • Investigational Site Number 0320002

    Caba, 1120

  • Investigational Site Number 0320013

    Caba, 1425DES

  • Investigational Site Number 0320010

    Caba, 1425

  • Investigational Site Number 0320005

    Caba, C1119ACN

  • Investigational Site Number 0320008

    Capital Federal, C1056ABJ

  • Investigational Site Number 0320001

    Capital Federal, C1179AAB

  • Investigational Site Number 0320004

    Corrientes, W3400AMZ

  • Investigational Site Number 0320012

    Corrientes, W3410AVV

  • Investigational Site Number 0320011

    Godoy Cruz, M5501ARP

  • Investigational Site Number 0320007

    Mar del Plata, B7600FZN

  • Investigational Site Number 0320006

    Merlo, B1722COV

  • Investigational Site Number 0320015

    Rosario, 2000

  • Investigational Site Number 0320017

    Rosario, S2002OJP

  • Investigational Site Number 0320003

    Salta, 4400

  • Investigational Site Number 0320018

    Salta, 4400

  • Investigational Site Number 0320016

    San Isidro, B1642DCB

  • Investigational Site Number 0320014

    Santa Rosa

Other trials in Argentina

Russia18 sites

  • Investigational Site Number 6430018

    Kaliningrad, 236035

  • Investigational Site Number 6430014

    Kazan', 420087

  • Investigational Site Number 6430001

    Kemerovo, 650002

  • Investigational Site Number 6430017

    Krasnogorsk, 143408

  • Investigational Site Number 6430004

    Moscow, 111539

  • Investigational Site Number 6430005

    Moscow, 117292

  • Investigational Site Number 6430002

    Moscow, 121374

  • Investigational Site Number 6430015

    Moscow, 121552

  • Investigational Site Number 6430009

    Novosibirsk, 630055

  • Investigational Site Number 6430019

    Novosibirsk, 630087

  • Investigational Site Number 6430006

    Saint Petersburg, 190013

  • Investigational Site Number 6430010

    Saint Petersburg, 193312

  • Investigational Site Number 6430011

    Saint Petersburg, 193312

  • Investigational Site Number 6430013

    Saint Petersburg, 194156

  • Investigational Site Number 6430016

    Saint Petersburg, 195067

  • Investigational Site Number 6430012

    Saint Petersburg, 198205

  • Investigational Site Number 6430003

    Saratov, 410028

  • Investigational Site Number 6430020

    Saratov, 410039

Other trials in Russia

Bulgaria15 sites

  • Investigational Site Number 1000011

    Blagoevgrad, 2700

  • Investigational Site Number 1000014

    Dimitrovgrad

  • Investigational Site Number 1000017

    Gabrovo, 5300

  • Investigational Site Number 1000007

    Kazanlak, 6100

  • Investigational Site Number 1000013

    Kyustendil

  • Investigational Site Number 1000010

    Lovech, 5500

  • Investigational Site Number 1000008

    Plovdiv, 4000

  • Investigational Site Number 1000002

    Plovdiv, 4002

  • Investigational Site Number 1000012

    Rousse, 7002

  • Investigational Site Number 1000003

    Sofia, 1233

  • Investigational Site Number 1000001

    Sofia, 1431

  • Investigational Site Number 1000005

    Sofia, 1750

  • Investigational Site Number 1000006

    Stara Zagora, 6000

  • Investigational Site Number 1000009

    Varna, 9000

  • Investigational Site Number 1000016

    Yambol, 8600

Other trials in Bulgaria

Poland15 sites

  • Investigational Site Number 6160017

    Bialystok, 15-404

  • Investigational Site Number 6160018

    Bydgoszcz, 80-095

  • Investigational Site Number 6160015

    Bydgoszcz, 85-090

  • Investigational Site Number 6160016

    Gdansk, 80-546

  • Investigational Site Number 6160012

    Gdansk, 80-858

  • Investigational Site Number 6160005

    Katowice, 40-530

  • Investigational Site Number 6160006

    Płock, 09-402

  • Investigational Site Number 6160011

    Skierniewice, 96-100

  • Investigational Site Number 6160013

    Skorzewo, 60-185

  • Investigational Site Number 6160010

    Szczecin, 70-506

  • Investigational Site Number 6160007

    Torun, 87-100

  • Investigational Site Number 6160009

    Torun, 87-100

  • Investigational Site Number 6160014

    Tychy, 43-100

  • Investigational Site Number 6160002

    Warsaw, 02-507

  • Investigational Site Number 6160004

    Wroclaw, 50-315

Other trials in Poland

Mexico14 sites

  • Investigational Site Number 4840004

    Actopan, 42500

  • Investigational Site Number 4840007

    Aguascalientes, 20230

  • Investigational Site Number 4840009

    Aguascalientes, 20230

  • Investigational Site Number 4840013

    Aguascalientes, 20230

  • Investigational Site Number 4840014

    Chihuahua City, 31000

  • Investigational Site Number 4840002

    Cuernavaca, 62250

  • Investigational Site Number 4840016

    Durango, 34000

  • Investigational Site Number 4840015

    Durango, 34080

  • Investigational Site Number 4840006

    Guadalajara, 44210

  • Investigational Site Number 4840003

    Guadalajara, 44600

  • Investigational Site Number 4840005

    Guadalajara, 44650

  • Investigational Site Number 4840011

    Monterrey, 64020

  • Investigational Site Number 4840010

    Monterrey, 64060

  • Investigational Site Number 4840001

    Monterrey, 64460

Other trials in Mexico

Chile13 sites

  • Investigational Site Number 1520012

    Antofagasta, 1270013

  • Investigational Site Number 1520008

    Concepción, 4070566

  • Investigational Site Number 1520013

    Santiago, 7500571

  • Investigational Site Number 1520002

    Santiago, 7500710

  • Investigational Site Number 1520007

    Santiago, 7500710

  • Investigational Site Number 1520011

    Santiago, 7770086

  • Investigational Site Number 1520010

    Santiago, 8053095

  • Investigational Site Number 1520001

    Santiago, 8330336

  • Investigational Site Number 1520003

    Santiago, 8380456

  • Investigational Site Number 1520014

    Santiago, 8900132

  • Investigational Site Number 1520005

    Santiago

  • Investigational Site Number 1520006

    Temuco, 4813299

  • Investigational Site Number 1520004

    Viña del Mar

Other trials in Chile

Spain13 sites

  • Investigational Site Number 7240008

    Alcorcón, 28922

  • Investigational Site Number 7240002

    Barcelona, 08035

  • Investigational Site Number 7240009

    Barcelona, 08041

  • Investigational Site Number 7240007

    Granada, 18014

  • Investigational Site Number 7240010

    Madrid, 28023

  • Investigational Site Number 7240001

    Madrid, 28040

  • Investigational Site Number 7240006

    Majadahonda, 28222

  • Investigational Site Number 7240011

    Málaga, 29010

  • Investigational Site Number 7240005

    Olot, 17800

  • Investigational Site Number 7240003

    San Sebastián de los Reyes, 28702

  • Investigational Site Number 7240013

    Seville, 41014

  • Investigational Site Number 7240004

    Valencia, 46010

  • Investigational Site Number 7240014

    Valencia, 46026

Other trials in Spain

Slovakia12 sites

  • Investigational Site Number 7030007

    Bratislava, 85101

  • Investigational Site Number 7030001

    Košice, 040 01

  • Investigational Site Number 7030004

    Košice, 040 01

  • Investigational Site Number 7030003

    Kráľovský Chlmec, 077 01

  • Investigational Site Number 7030009

    Moldava nad Bodvou, 04525

  • Investigational Site Number 7030010

    Pezinok, 90201

  • Investigational Site Number 7030006

    Považská Bystrica, 01701

  • Investigational Site Number 7030005

    Prešov, 080 01

  • Investigational Site Number 7030008

    Rožňava, 04801

  • Investigational Site Number 7030011

    Štúrovo, 943 01

  • Investigational Site Number 7030002

    Trebišov, 075 01

  • Investigational Site Number 7030012

    Trenčín, 91101

Other trials in Slovakia

Turkey (Türkiye)12 sites

  • Investigational Site Number 7920005

    Adana, 01250

  • Investigational Site Number 7920010

    Ankara, 06490

  • Investigational Site Number 7920012

    Antalya, 07070

  • Investigational Site Number 7920015

    Aydin, 09100

  • Investigational Site Number 7920002

    Bursa, 16059

  • Investigational Site Number 7920013

    Eskişehir, 26040

  • Investigational Site Number 7920001

    Istanbul, 34393

  • Investigational Site Number 7920006

    Istanbul, 34843

  • Investigational Site Number 7920011

    İzmit, 41380

  • Investigational Site Number 7920014

    Kütahya, 43040

  • Investigational Site Number 7920007

    Samsun, 55139

  • Investigational Site Number 7920009

    Sivas, 58140

Other trials in Turkey (Türkiye)

Hungary11 sites

  • Investigational Site Number 3480012

    Balatonfüred, 8230

  • Investigational Site Number 3480011

    Budapest, 1036

  • Investigational Site Number 3480003

    Budapest, 1042

  • Investigational Site Number 3480005

    Budapest, 1106

  • Investigational Site Number 3480001

    Budapest, 1122

  • Investigational Site Number 3480006

    Budapest, 1134

  • Investigational Site Number 3480002

    Debrecen, 4032

  • Investigational Site Number 3480009

    Komárom, 2900

  • Investigational Site Number 3480008

    Mosonmagyaróvár, 9200

  • Investigational Site Number 3480007

    Székesfehérvár, 8000

  • Investigational Site Number 3480004

    Zalaegerszeg, 8900

Other trials in Hungary

Romania10 sites

  • Investigational Site Number 6420007

    Bacau, 600154

  • Investigational Site Number 6420001

    Brasov, 500097

  • Investigational Site Number 6420011

    Brasov, 500365

  • Investigational Site Number 6420009

    Bucharest, 020475

  • Investigational Site Number 6420012

    Oradea, 410151

  • Investigational Site Number 6420005

    Oradea, 410159

  • Investigational Site Number 6420010

    Oradea, 410169

  • Investigational Site Number 6420008

    Ploieşti, 100561

  • Investigational Site Number 6420002

    Târgu Mureş, 540142

  • Investigational Site Number 6420003

    Târgu Mureş, 540142

Other trials in Romania

South Korea10 sites

  • Investigational Site Number 4100007

    Busan, 49241

  • Investigational Site Number 4100006

    Guri-si, Gyeonggi-do, 11923

  • Investigational Site Number 4100005

    Seoul, 02841

  • Investigational Site Number 4100002

    Seoul, 03080

  • Investigational Site Number 4100009

    Seoul, 03181

  • Investigational Site Number 4100001

    Seoul, 03722

  • Investigational Site Number 4100011

    Seoul, 06351

  • Investigational Site Number 4100003

    Seoul, 06591

  • Investigational Site Number 4100010

    Seoul, 08308

  • Investigational Site Number 4100008

    Wŏnju, 26426

Other trials in South Korea

India9 sites

  • Investigational Site Number 3560001

    Belagavi, 590010

  • Investigational Site Number 3560002

    Gūrgaon, 122001

  • Investigational Site Number 3560007

    Kolkata, 700073

  • Investigational Site Number 3560006

    Lucknow, 226002

  • Investigational Site Number 3560003

    New Delhi, 110 029

  • Investigational Site Number 3560009

    New Delhi, 110060

  • Investigational Site Number 3560010

    Pune, 411001

  • Investigational Site Number 3560005

    Pune, 411010

  • Investigational Site Number 3560004

    Vellore, 632004

Other trials in India

Ukraine9 sites

  • Investigational Site Number 8040006

    Dnipro, 49005

  • Investigational Site Number 8040009

    Ivano-Frankivsk, 76008

  • Investigational Site Number 8040001

    Ivano-Frankivsk, 76018

  • Investigational Site Number 8040003

    Kharkiv, 61124

  • Investigational Site Number 8040002

    Kharkiv, 61166

  • Investigational Site Number 8040007

    Kiev, 02091

  • Investigational Site Number 8040008

    Kyiv, 01004

  • Investigational Site Number 8040004

    Ternopil, 46000

  • Investigational Site Number 8040005

    Vinnytsia, 21001

Other trials in Ukraine

Germany8 sites

  • Investigational Site Number 2760006

    Berlin, 10437

  • Investigational Site Number 2760009

    Berlin, 12627

  • Investigational Site Number 2760004

    Essen, 45355

  • Investigational Site Number 2760008

    Frankfurt am Main, 60313

  • Investigational Site Number 2760005

    Münster, 48145

  • Investigational Site Number 2760003

    Oldenburg in Holstein, 23758

  • Investigational Site Number 2760002

    Pirna, 01796

  • Investigational Site Number 2760007

    Rotenburg an der Fulda, 36199

Other trials in Germany

South Africa8 sites

  • Investigational Site Number 7100007

    Bloemfontein, 9301

  • Investigational Site Number 7100005

    Cape Town, 7130

  • Investigational Site Number 7100006

    Cape Town

  • Investigational Site Number 7100003

    Johannesburg, 1752

  • Investigational Site Number 7100001

    Johannesburg, 2198

  • Investigational Site Number 7100002

    Parow, 7500

  • Investigational Site Number 7100004

    Rivonia, 2128

  • Investigational Site Number 7100008

    Umhlanga Rocks Suburb

Other trials in South Africa

Peru7 sites

  • Investigational Site Number 6040007

    Lima, LIMA 01

  • Investigational Site Number 6040004

    Lima, LIMA 11

  • Investigational Site Number 6040003

    Lima, LIMA 27

  • Investigational Site Number 6040006

    Lima, LIMA 31

  • Investigational Site Number 6040001

    Lima

  • Investigational Site Number 6040005

    Lima

  • Investigational Site Number 6040002

    Piura, 20000

Other trials in Peru

Italy6 sites

  • Investigational Site Number 3800006

    Catania, 95123

  • Investigational Site Number 3800003

    Catanzaro, 88100

  • Investigational Site Number 3800005

    Catanzaro, 88100

  • Investigational Site Number 3800002

    Chieti, 66013

  • Investigational Site Number 3800001

    Milan, 20132

  • Investigational Site Number 3800004

    Roma, 00133

Other trials in Italy

Serbia6 sites

  • Investigational Site Number 6880001

    Belgrade, 11000

  • Investigational Site Number 6880002

    Belgrade, 11000

  • Investigational Site Number 6880003

    Belgrade, 11050

  • Investigational Site Number 6880005

    Belgrade, 11050

  • Investigational Site Number 6880004

    Kragujevac, 34000

  • Investigational Site Number 6880006

    Novi Sad, 21000

Other trials in Serbia

Sweden6 sites

  • Investigational Site Number 7520006

    Gothenburg, 41345

  • Investigational Site Number 7520003

    Helsingborg, 252 20

  • Investigational Site Number 7520004

    Kristianstad, 291 85

  • Investigational Site Number 7520002

    Malmö, 211 52

  • Investigational Site Number 7520005

    Skövde, 541 40

  • Investigational Site Number 7520001

    Stockholm, 171 76

Other trials in Sweden

Denmark5 sites

  • Investigational Site Number 2080004

    Aarhus N, 8200

  • Investigational Site Number 2080005

    Esbjerg, 6700

  • Investigational Site Number 2080001

    Hellerup, 2900

  • Investigational Site Number 2080003

    Hvidovre, 2650

  • Investigational Site Number 2080002

    København NV, 2400

Other trials in Denmark

Finland4 sites

  • Investigational Site Number 2460002

    Helsinki, 00100

  • Investigational Site Number 2460001

    Jyväskylä, 40620

  • Investigational Site Number 2460003

    Kuopio, 70100

  • Investigational Site Number 2460004

    Oulu, 90220

Other trials in Finland

Latvia4 sites

  • Investigational Site Number 4280004

    Daugavpils, LV-5417

  • Investigational Site Number 4280002

    Liepāja, LV3414

  • Investigational Site Number 4280001

    Riga, LV-1011

  • Investigational Site Number 4280003

    Sigulda, LV-2150

Other trials in Latvia

Lithuania4 sites

  • Investigational Site Number 4400001

    Kaunas, 49449

  • Investigational Site Number 4400002

    Kaunas, 50161

  • Investigational Site Number 4400003

    Klaipėda, 92111

  • Investigational Site Number 4400004

    Vilnius, 08661

Other trials in Lithuania

Estonia3 sites

  • Investigational Site Number 2330002

    Pärnu, 80018

  • Investigational Site Number 2330001

    Tallinn, 13419

  • Investigational Site Number 2330003

    Viljandi, 71024

Other trials in Estonia

Norway3 sites

  • Investigational Site Number 5780002

    Hamar, 2317

  • Investigational Site Number 5780001

    Oslo

  • Investigational Site Number 5780003

    Stavanger, 4011

Other trials in Norway

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk

Primary Objective:

To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.

Secondary Objectives:

To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters:

  • 3-point MACE.
  • Expanded CV outcome.
  • Composite outcome of new or worsening nephropathy.

To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.

Read the detailed description

The study duration per participant was up to approximately 36 months.

Being tested
Efpeglenatide (SAR439977), Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Efpeglenatide (SAR439977)Drug

    Pharmaceutical form: Solution for injection,

    Route of administration: SC

  • PlaceboDrug

    Pharmaceutical form: Solution for injection

    Route of administration: SC

Study groups in NCT03496298
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment.
Receives: Drug: Placebo
Efpeglenatide 4 mgExperimentalParticipants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment.
Receives: Drug: Efpeglenatide (SAR439977)
Efpeglenatide 6 mgExperimentalParticipants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment.
Receives: Drug: Efpeglenatide (SAR439977)

What is being measured

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

  1. Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis

    All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

    Measured: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

Secondary outcomes (3)

  1. Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis

    All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

    Measured: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

  2. Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event

    All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.

    Measured: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

  3. Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint

    Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (>) 300, as measured in mg of albumin to grams of creatinine, or >33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

    Measured: From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)

Timeline

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

  1. First posted12 Apr 2018
  2. Study start27 Apr 2018
  3. Primary completion10 Dec 2020
  4. Study completion10 Dec 2020

Why it stopped: Sponsor decision to cancel TRIAL, not related to safety concern

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,076 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03496298
Sponsor's protocol ID
EFC14828
Other IDs
2017-002954-35, U1111-1186-2533, 2017
Acronym
AMPLITUDE-O
Status last verified
Aug 2021
First submitted
5 Apr 2018
Last updated
15 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No plan to share individual participant data (IPD) by Sanofi: product rights transferred to Hanmi pharmaceutical.

Publications

  • Gerstein HC, Sattar N, Rosenstock J, Ramasundarahettige C, Pratley R, Lopes RD, Lam CSP, Khurmi NS, Heenan L, Del Prato S, Dyal L, Branch K; AMPLITUDE-O Trial Investigators. Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med. 2021 Sep 2;385(10):896-907. doi: 10.1056/NEJMoa2108269. Epub 2021 Jun 28.

    PubMed 34215025

  • 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, Li Z, Ramasundarahettige C, Baek S, Branch KRH, Del Prato S, Lam CSP, Lopes RD, Pratley R, Rosenstock J, Sattar N. Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial. Circulation. 2023 Mar 28;147(13):1004-1013. doi: 10.1161/CIRCULATIONAHA.122.063716. Epub 2023 Feb 20.

    PubMed 36802715

  • Lam CSP, Ramasundarahettige C, Branch KRH, Sattar N, Rosenstock J, Pratley R, Del Prato S, Lopes RD, Niemoeller E, Khurmi NS, Baek S, Gerstein HC. Efpeglenatide and Clinical Outcomes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use in Type 2 Diabetes: Exploratory Analysis of the AMPLITUDE-O Trial. Circulation. 2022 Feb 22;145(8):565-574. doi: 10.1161/CIRCULATIONAHA.121.057934. Epub 2021 Nov 14.

    PubMed 34775781

  • Gerstein HC, Branch K, Heenan L, Del Prato S, Khurmi NS, Lam CSP, Pratley R, Rosenstock J, Sattar N. Design and baseline characteristics of the AMPLITUDE-O cardiovascular outcomes trial of efpeglenatide, a weekly glucagon-like peptide-1 receptor agonist. Diabetes Obes Metab. 2021 Feb;23(2):318-323. doi: 10.1111/dom.14223. Epub 2020 Oct 22.

    PubMed 33026143

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Efpeglenatide (SAR439977) in people with Type 2 Diabetes Mellitus, run by Sanofi at 353 sites in 28 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 12 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: stopped early, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 353 sites in United States, Canada, Argentina, Russia, Bulgaria and 23 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 15 Oct 2021). 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?

Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis (time frame: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)). 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 NCT03496298, which also lists 5 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 15 Oct 2021.

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