Effect of Efpeglenatide on Cardiovascular Outcomes (AMPLITUDE-O)

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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: Efpeglenatide (SAR439977)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 4076
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1430
    • Investigational Site Number 0320009
  • Caba, Argentina, 1120
    • Investigational Site Number 0320002
  • Caba, Argentina, 1425DES
    • Investigational Site Number 0320013
  • Caba, Argentina, 1425
    • Investigational Site Number 0320010
  • Caba, Argentina, C1119ACN
    • Investigational Site Number 0320005
  • Capital Federal, Argentina, C1056ABJ
    • Investigational Site Number 0320008
  • Capital Federal, Argentina, C1179AAB
    • Investigational Site Number 0320001
  • Corrientes, Argentina, W3400AMZ
    • Investigational Site Number 0320004
  • Corrientes, Argentina, W3410AVV
    • Investigational Site Number 0320012
  • Godoy Cruz, Argentina, M5501ARP
    • Investigational Site Number 0320011
  • Mar Del Plata, Argentina, B7600FZN
    • Investigational Site Number 0320007
  • Merlo, Argentina, B1722COV
    • Investigational Site Number 0320006
  • Rosario, Argentina, 2000
    • Investigational Site Number 0320015
  • Rosario, Argentina, S2002OJP
    • Investigational Site Number 0320017
  • Salta, Argentina, 4400
    • Investigational Site Number 0320003
  • Salta, Argentina, 4400
    • Investigational Site Number 0320018
  • San Isidro, Argentina, B1642DCB
    • Investigational Site Number 0320016
  • Santa Rosa, Argentina
    • Investigational Site Number 0320014
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Investigational Site Number 1000011
  • Dimitrovgrad, Bulgaria
    • Investigational Site Number 1000014
  • Gabrovo, Bulgaria, 5300
    • Investigational Site Number 1000017
  • Kazanlak, Bulgaria, 6100
    • Investigational Site Number 1000007
  • Kyustendil, Bulgaria
    • Investigational Site Number 1000013
  • Lovech, Bulgaria, 5500
    • Investigational Site Number 1000010
  • Plovdiv, Bulgaria, 4000
    • Investigational Site Number 1000008
  • Plovdiv, Bulgaria, 4002
    • Investigational Site Number 1000002
  • Ruse, Bulgaria, 7002
    • Investigational Site Number 1000012
  • Sofia, Bulgaria, 1233
    • Investigational Site Number 1000003
  • Sofia, Bulgaria, 1431
    • Investigational Site Number 1000001
  • Sofia, Bulgaria, 1750
    • Investigational Site Number 1000005
  • Stara Zagora, Bulgaria, 6000
    • Investigational Site Number 1000006
  • Varna, Bulgaria, 9000
    • Investigational Site Number 1000009
  • Yambol, Bulgaria, 8600
    • Investigational Site Number 1000016
• Canada
  • Barrie, Canada, L4N 7L3
    • Investigational Site Number 1240001
  • Brampton, Canada, L6S 0C6
    • Investigational Site Number 1240002
  • Burlington, Canada, L7M 1K9
    • Investigational Site Number 1240018
  • Burlington, Canada, L7R 1E2
    • Investigational Site Number 1240021
  • Calgary, Canada, T2H 2G4
    • Investigational Site Number 1240007
  • Calgary, Canada, T2V 4J2
    • Investigational Site Number 1240020
  • Chicoutimi, Canada, G7H 7K9
    • Investigational Site Number 1240024
  • Concord, Canada, L4K 4M2
    • Investigational Site Number 1240004
  • Etobicoke, Canada, M9R 4E1
    • Investigational Site Number 1240005
  • Levis, Canada, G6W 0M5
    • Investigational Site Number 1240011
  • London, Canada, N5W 6A2
    • Investigational Site Number 1240025
  • London, Canada, N6A 5R8
    • Investigational Site Number 1240028
  • Mirabel, Canada, J7J 2K8
    • Investigational Site Number 1240029
  • Montreal, Canada, H1M 1B1
    • Investigational Site Number 1240008
  • Montreal, Canada, H1T 1C8
    • Investigational Site Number 1240031
  • Montreal, Canada, H4A 2C6
    • Investigational Site Number 1240014
  • Montreal, Canada, H4A 3T2
    • Investigational Site Number 1240023
  • Montreal, Canada, H4N 2W2
    • Investigational Site Number 1240017
  • Oakville, Canada, L6M 1M1
    • Investigational Site Number 1240015
  • Oshawa, Canada, L1J 2K1
    • Investigational Site Number 1240012
  • Ottawa, Canada, K2J 0V2
    • Investigational Site Number 1240030
  • Peterborough, Canada, K9J 0B2
    • Investigational Site Number 1240027
  • Pointe-Claire, Canada, H9R 4S3
    • Investigational Site Number 1240016
  • Quebec, Canada, G1N 4V3
    • Investigational Site Number 1240010
  • Red Deer, Canada, T4N 6V7
    • Investigational Site Number 1240019
  • Sherbrooke, Canada, J1L 0H8
    • Investigational Site Number 1240006
  • Sudbury, Canada, P3E 4H5
    • Investigational Site Number 1240022
  • Toronto, Canada, M4G 3E8
    • Investigational Site Number 1240013
  • Vancouver, Canada, V5Y 3W2
    • Investigational Site Number 1240003
  • Victoria, Canada, V8V 4A1
    • Investigational Site Number 1240026
  • Victoriaville, Canada, G6P 6P6
    • Investigational Site Number 1240009
• Chile
  • Antofagasta, Chile, 1270013
    • Investigational Site Number 1520012
  • Concepción, Chile, 4070566
    • Investigational Site Number 1520008
  • Santiago, Chile, 7500571
    • Investigational Site Number 1520013
  • Santiago, Chile, 7500710
    • Investigational Site Number 1520002
  • Santiago, Chile, 7500710
    • Investigational Site Number 1520007
  • Santiago, Chile, 7770086
    • Investigational Site Number 1520011
  • Santiago, Chile, 8053095
    • Investigational Site Number 1520010
  • Santiago, Chile, 8330336
    • Investigational Site Number 1520001
  • Santiago, Chile, 8380456
    • Investigational Site Number 1520003
  • Santiago, Chile, 8900132
    • Investigational Site Number 1520014
  • Santiago, Chile
    • Investigational Site Number 1520005
  • Temuco, Chile, 4813299
    • Investigational Site Number 1520006
  • Viña Del Mar, Chile
    • Investigational Site Number 1520004
• Denmark
  • Aarhus N, Denmark, 8200
    • Investigational Site Number 2080004
  • Esbjerg, Denmark, 6700
    • Investigational Site Number 2080005
  • Hellerup, Denmark, 2900
    • Investigational Site Number 2080001
  • Hvidovre, Denmark, 2650
    • Investigational Site Number 2080003
  • København Nv, Denmark, 2400
    • Investigational Site Number 2080002
• Estonia
  • Pärnu, Estonia, 80018
    • Investigational Site Number 2330002
  • Tallinn, Estonia, 13419
    • Investigational Site Number 2330001
  • Viljandi, Estonia, 71024
    • Investigational Site Number 2330003
• Finland
  • Helsinki, Finland, 00100
    • Investigational Site Number 2460002
  • Jyväskylä, Finland, 40620
    • Investigational Site Number 2460001
  • Kuopio, Finland, 70100
    • Investigational Site Number 2460003
  • Oulu, Finland, 90220
    • Investigational Site Number 2460004
• Germany
  • Berlin, Germany, 10437
    • Investigational Site Number 2760006
  • Berlin, Germany, 12627
    • Investigational Site Number 2760009
  • Essen, Germany, 45355
    • Investigational Site Number 2760004
  • Frankfurt Am Main, Germany, 60313
    • Investigational Site Number 2760008
  • Münster, Germany, 48145
    • Investigational Site Number 2760005
  • Oldenburg In Holstein, Germany, 23758
    • Investigational Site Number 2760003
  • Pirna, Germany, 01796
    • Investigational Site Number 2760002
  • Rotenburg An Der Fulda, Germany, 36199
    • Investigational Site Number 2760007
• Hungary
  • Balatonfüred, Hungary, 8230
    • Investigational Site Number 3480012
  • Budapest, Hungary, 1036
    • Investigational Site Number 3480011
  • Budapest, Hungary, 1042
    • Investigational Site Number 3480003
  • Budapest, Hungary, 1106
    • Investigational Site Number 3480005
  • Budapest, Hungary, 1122
    • Investigational Site Number 3480001
  • Budapest, Hungary, 1134
    • Investigational Site Number 3480006
  • Debrecen, Hungary, 4032
    • Investigational Site Number 3480002
  • Komárom, Hungary, 2900
    • Investigational Site Number 3480009
  • Mosonmagyaróvár, Hungary, 9200
    • Investigational Site Number 3480008
  • Székesfehérvár, Hungary, 8000
    • Investigational Site Number 3480007
  • Zalaegerszeg, Hungary, 8900
    • Investigational Site Number 3480004
• India
  • Belgaum, India, 590010
    • Investigational Site Number 3560001
  • Gurgaon, India, 122001
    • Investigational Site Number 3560002
  • Kolkata, India, 700073
    • Investigational Site Number 3560007
  • Lucknow, India, 226002
    • Investigational Site Number 3560006
  • New Delhi, India, 110 029
    • Investigational Site Number 3560003
  • New Delhi, India, 110060
    • Investigational Site Number 3560009
  • Pune, India, 411001
    • Investigational Site Number 3560010
  • Pune, India, 411010
    • Investigational Site Number 3560005
  • Vellore, India, 632004
    • Investigational Site Number 3560004
• Italy
  • Catania, Italy, 95123
    • Investigational Site Number 3800006
  • Catanzaro, Italy, 88100
    • Investigational Site Number 3800003
  • Catanzaro, Italy, 88100
    • Investigational Site Number 3800005
  • Chieti, Italy, 66013
    • Investigational Site Number 3800002
  • Milano, Italy, 20132
    • Investigational Site Number 3800001
  • Roma, Italy, 00133
    • Investigational site number 3800004
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Investigational Site Number 4100007
  • Seoul, Korea, Republic of, 02841
    • Investigational Site Number 4100005
  • Seoul, Korea, Republic of, 03080
    • Investigational Site Number 4100002
  • Seoul, Korea, Republic of, 03181
    • Investigational Site Number 4100009
  • Seoul, Korea, Republic of, 03722
    • Investigational Site Number 4100001
  • Seoul, Korea, Republic of, 06351
    • Investigational Site Number 4100011
  • Seoul, Korea, Republic of, 06591
    • Investigational Site Number 4100003
  • Seoul, Korea, Republic of, 08308
    • Investigational Site Number 4100010
  • Wonju, Korea, Republic of, 26426
    • Investigational Site Number 4100008
  • Gyeonggi-Do
    • Guri-si, Gyeonggi-Do, Korea, Republic of, 11923
      • Investigational Site Number 4100006
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Investigational Site Number 4280004
  • Liepāja, Latvia, LV3414
    • Investigational Site Number 4280002
  • Riga, Latvia, LV-1011
    • Investigational Site Number 4280001
  • Sigulda, Latvia, LV-2150
    • Investigational Site Number 4280003
• Lithuania
  • Kaunas, Lithuania, 49449
    • Investigational Site Number 4400001
  • Kaunas, Lithuania, 50161
    • Investigational Site Number 4400002
  • Klaipeda, Lithuania, 92111
    • Investigational Site Number 4400003
  • Vilnius, Lithuania, 08661
    • Investigational Site Number 4400004
• Mexico
  • Actopan, Mexico, 42500
    • Investigational Site Number 4840004
  • Aguascalientes, Mexico, 20230
    • Investigational Site Number 4840007
  • Aguascalientes, Mexico, 20230
    • Investigational Site Number 4840009
  • Aguascalientes, Mexico, 20230
    • Investigational Site Number 4840013
  • Chihuahua, Mexico, 31000
    • Investigational Site Number 4840014
  • Cuernavaca, Mexico, 62250
    • Investigational Site Number 4840002
  • Durango, Mexico, 34000
    • Investigational Site Number 4840016
  • Durango, Mexico, 34080
    • Investigational Site Number 4840015
  • Guadalajara, Mexico, 44210
    • Investigational Site Number 4840006
  • Guadalajara, Mexico, 44600
    • Investigational Site Number 4840003
  • Guadalajara, Mexico, 44650
    • Investigational Site Number 4840005
  • Monterrey, Mexico, 64020
    • Investigational Site Number 4840011
  • Monterrey, Mexico, 64060
    • Investigational Site Number 4840010
  • Monterrey, Mexico, 64460
    • Investigational Site Number 4840001
• Norway
  • Hamar, Norway, 2317
    • Investigational Site Number 5780002
  • Oslo, Norway
    • Investigational Site Number 5780001
  • Stavanger, Norway, 4011
    • Investigational Site Number 5780003
• Peru
  • Lima, Peru, LIMA 01
    • Investigational Site Number 6040007
  • Lima, Peru, LIMA 11
    • Investigational Site Number 6040004
  • Lima, Peru, LIMA 27
    • Investigational Site Number 6040003
  • Lima, Peru, LIMA 31
    • Investigational Site Number 6040006
  • Lima, Peru
    • Investigational Site Number 6040001
  • Lima, Peru
    • Investigational Site Number 6040005
  • Piura, Peru, 20000
    • Investigational Site Number 6040002
• Poland
  • Bialystok, Poland, 15-404
    • Investigational Site Number 6160017
  • Bydgoszcz, Poland, 80-095
    • Investigational Site Number 6160018
  • Bydgoszcz, Poland, 85-090
    • Investigational Site Number 6160015
  • Gdansk, Poland, 80-546
    • Investigational Site Number 6160016
  • Gdansk, Poland, 80-858
    • Investigational Site Number 6160012
  • Katowice, Poland, 40-530
    • Investigational Site Number 6160005
  • Plock, Poland, 09-402
    • Investigational Site Number 6160006
  • Skierniewice, Poland, 96-100
    • Investigational Site Number 6160011
  • Skorzewo, Poland, 60-185
    • Investigational Site Number 6160013
  • Szczecin, Poland, 70-506
    • Investigational Site Number 6160010
  • Torun, Poland, 87-100
    • Investigational Site Number 6160007
  • Torun, Poland, 87-100
    • Investigational Site Number 6160009
  • Tychy, Poland, 43-100
    • Investigational Site Number 6160014
  • Warszawa, Poland, 02-507
    • Investigational Site Number 6160002
  • Wroclaw, Poland, 50-315
    • Investigational Site Number 6160004
• Romania
  • Bacau, Romania, 600154
    • Investigational Site Number 6420007
  • Brasov, Romania, 500097
    • Investigational Site Number 6420001
  • Brasov, Romania, 500365
    • Investigational Site Number 6420011
  • Bucuresti, Romania, 020475
    • Investigational Site Number 6420009
  • Oradea, Romania, 410151
    • Investigational Site Number 6420012
  • Oradea, Romania, 410159
    • Investigational Site Number 6420005
  • Oradea, Romania, 410169
    • Investigational Site Number 6420010
  • Ploiesti, Romania, 100561
    • Investigational Site Number 6420008
  • Târgu-Mureş, Romania, 540142
    • Investigational Site Number 6420002
  • Târgu-Mureş, Romania, 540142
    • Investigational Site Number 6420003
• Russian Federation
  • Kaliningrad, Russian Federation, 236035
    • Investigational Site Number 6430018
  • Kazan, Russian Federation, 420087
    • Investigational Site Number 6430014
  • Kemerovo, Russian Federation, 650002
    • Investigational Site Number 6430001
  • Krasnogorsk, Russian Federation, 143408
    • Investigational Site Number 6430017
  • Moscow, Russian Federation, 111539
    • Investigational Site Number 6430004
  • Moscow, Russian Federation, 117292
    • Investigational Site Number 6430005
  • Moscow, Russian Federation, 121374
    • Investigational Site Number 6430002
  • Moscow, Russian Federation, 121552
    • Investigational Site Number 6430015
  • Novosibirsk, Russian Federation, 630055
    • Investigational Site Number 6430009
  • Novosibirsk, Russian Federation, 630087
    • Investigational Site Number 6430019
  • Saint-Petersburg, Russian Federation, 190013
    • Investigational Site Number 6430006
  • Saint-Petersburg, Russian Federation, 198205
    • Investigational Site Number 6430012
  • Saratov, Russian Federation, 410028
    • Investigational Site Number 6430003
  • Saratov, Russian Federation, 410039
    • Investigational Site Number 6430020
  • St-Petersburg, Russian Federation, 193312
    • Investigational Site Number 6430010
  • St-Petersburg, Russian Federation, 193312
    • Investigational Site Number 6430011
  • St. Petersburg, Russian Federation, 194156
    • Investigational Site Number 6430013
  • St. Petersburg, Russian Federation, 195067
    • Investigational Site Number 6430016
• Serbia
  • Belgrade, Serbia, 11000
    • Investigational Site Number 6880001
  • Belgrade, Serbia, 11000
    • Investigational Site Number 6880002
  • Belgrade, Serbia, 11050
    • Investigational Site Number 6880003
  • Belgrade, Serbia, 11050
    • Investigational Site Number 6880005
  • Kragujevac, Serbia, 34000
    • Investigational Site Number 6880004
  • Novi Sad, Serbia, 21000
    • Investigational Site Number 6880006
• Slovakia
  • Bratislava, Slovakia, 85101
    • Investigational Site Number 7030007
  • Kosice, Slovakia, 040 01
    • Investigational Site Number 7030001
  • Kosice, Slovakia, 040 01
    • Investigational Site Number 7030004
  • Kralovsky Chlmec, Slovakia, 077 01
    • Investigational Site Number 7030003
  • Moldava Nad Bodvou, Slovakia, 04525
    • Investigational Site Number 7030009
  • Pezinok, Slovakia, 90201
    • Investigational Site Number 7030010
  • Povazska Bystrica, Slovakia, 01701
    • Investigational Site Number 7030006
  • Presov, Slovakia, 080 01
    • Investigational Site Number 7030005
  • Roznava, Slovakia, 04801
    • Investigational Site Number 7030008
  • Sturovo, Slovakia, 943 01
    • Investigational Site Number 7030011
  • Trebisov, Slovakia, 075 01
    • Investigational Site Number 7030002
  • Trencin, Slovakia, 91101
    • Investigational Site Number 7030012
• South Africa
  • Bloemfontein, South Africa, 9301
    • Investigational Site Number 7100007
  • Cape Town, South Africa, 7130
    • Investigational Site Number 7100005
  • Cape Town, South Africa
    • Investigational Site Number 7100006
  • Johannesburg, South Africa, 1752
    • Investigational Site Number 7100003
  • Johannesburg, South Africa, 2198
    • Investigational Site Number 7100001
  • Parow, South Africa, 7500
    • Investigational Site Number 7100002
  • Rivonia, South Africa, 2128
    • Investigational Site Number 7100004
  • Umhlanga Rocks Suburb, South Africa
    • Investigational Site Number 7100008
• Spain
  • Alcorcón, Spain, 28922
    • Investigational Site Number 7240008
  • Barcelona, Spain, 08035
    • Investigational Site Number 7240002
  • Barcelona, Spain, 08041
    • Investigational Site Number 7240009
  • Granada, Spain, 18014
    • Investigational Site Number 7240007
  • Madrid, Spain, 28023
    • Investigational Site Number 7240010
  • Madrid, Spain, 28040
    • Investigational Site Number 7240001
  • Majadahonda, Spain, 28222
    • Investigational Site Number 7240006
  • Málaga, Spain, 29010
    • Investigational Site Number 7240011
  • Olot, Spain, 17800
    • Investigational Site Number 7240005
  • San Sebastián De Los Reyes, Spain, 28702
    • Investigational Site Number 7240003
  • Sevilla, Spain, 41014
    • Investigational Site Number 7240013
  • Valencia, Spain, 46010
    • Investigational Site Number 7240004
  • Valencia, Spain, 46026
    • Investigational Site Number 7240014
• Sweden
  • Goteborg, Sweden, 41345
    • Investigational Site Number 7520006
  • Helsingborg, Sweden, 252 20
    • Investigational Site Number 7520003
  • Kristianstad, Sweden, 291 85
    • Investigational Site Number 7520004
  • Malmö, Sweden, 211 52
    • Investigational Site Number 7520002
  • Skövde, Sweden, 541 40
    • Investigational Site Number 7520005
  • Stockholm, Sweden, 171 76
    • Investigational Site Number 7520001
• Turkey
  • Adana, Turkey, 01250
    • Investigational site number 7920005
  • Ankara, Turkey, 06490
    • Investigational Site Number 7920010
  • Antalya, Turkey, 07070
    • Investigational Site Number 7920012
  • Aydin, Turkey, 09100
    • Investigational Site Number 7920015
  • Bursa, Turkey, 16059
    • Investigational Site Number 7920002
  • Eskisehir, Turkey, 26040
    • Investigational Site Number 7920013
  • Istanbul, Turkey, 34393
    • Investigational Site Number 7920001
  • Istanbul, Turkey, 34843
    • Investigational Site Number 7920006
  • Izmit, Turkey, 41380
    • Investigational Site Number 7920011
  • Kutahya, Turkey, 43040
    • Investigational Site Number 7920014
  • Samsun, Turkey, 55139
    • Investigational Site Number 7920007
  • Sivas, Turkey, 58140
    • Investigational Site Number 7920009
• Ukraine
  • Dnipro, Ukraine, 49005
    • Investigational Site Number 8040006
  • Ivano-Frankivsk, Ukraine, 76008
    • Investigational Site Number 8040009
  • Ivano-Frankivsk, Ukraine, 76018
    • Investigational Site Number 8040001
  • Kharkiv, Ukraine, 61124
    • Investigational Site Number 8040003
  • Kharkiv, Ukraine, 61166
    • Investigational Site Number 8040002
  • Kiev, Ukraine, 02091
    • Investigational Site Number 8040007
  • Kyiv, Ukraine, 01004
    • Investigational Site Number 8040008
  • Ternopil, Ukraine, 46000
    • Investigational Site Number 8040004
  • Vinnytsya, Ukraine, 21001
    • Investigational Site Number 8040005
• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Investigational Site Number 8400032
  • Arizona
    • Gilbert, Arizona, United States, 85295
      • Investigational Site Number 8400014
    • Surprise, Arizona, United States, 85374
      • Investigational Site Number 8400012
    • Tucson, Arizona, United States, 85745
      • Investigational Site Number 8400046
  • California
    • Beverly Hills, California, United States, 90211
      • Investigational Site Number 8400022
    • Concord, California, United States, 94520
      • Investigational Site Number 8400065
    • Greenbrae, California, United States, 94904
      • Investigational Site Number 8400060
    • Long Beach, California, United States, 90807
      • Investigational Site Number 8400084
    • Los Gatos, California, United States, 95032
      • Investigational Site Number 8400002
    • Northridge, California, United States, 91325
      • Investigational Site Number 8400085
    • Pomona, California, United States, 91767
      • Investigational Site Number 8400082
    • Sacramento, California, United States, 95821
      • Investigational Site Number 8400025
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Investigational Site Number 8400064
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • Investigational Site Number 8400019
    • Waterbury, Connecticut, United States, 06708-3346
      • Investigational Site Number 8400023
  • Florida
    • Hialeah, Florida, United States, 33012
      • Investigational Site Number 8400091
    • Hollywood, Florida, United States, 33024
      • Investigational Site Number 8400040
    • Hudson, Florida, United States, 34667
      • Investigational Site Number 8400073
    • Jacksonville, Florida, United States, 32204
      • Investigational Site Number 8400011
    • Jacksonville, Florida, United States, 32204
      • Investigational Site Number 8400017
    • Jacksonville, Florida, United States, 32277
      • Investigational Site Number 8400042
    • Miami, Florida, United States, 33126
      • Investigational Site Number 8400027
    • Miami, Florida, United States, 33136
      • Investigational Site Number 8400051
    • New Port Richey, Florida, United States, 34652
      • Investigational Site Number 8400041
    • Ormond Beach, Florida, United States, 32174
      • Investigational Site Number 8400059
  • Georgia
    • Macon, Georgia, United States, 31210-1359
      • Investigational Site Number 8400006
    • Roswell, Georgia, United States, 30076
      • Investigational Site Number 8400008
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Investigational Site Number 8400081
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Investigational Site Number 8400095
    • Chicago, Illinois, United States, 60607
      • Investigational Site Number 8400070
    • Crystal Lake, Illinois, United States, 60012
      • Investigational Site Number 8400036
  • Indiana
    • New Albany, Indiana, United States, 46113
      • Investigational Site Number 8400030
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Investigational Site Number 8400074
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Investigational Site Number 8400077
    • Paris, Kentucky, United States, 40361
      • Investigational Site Number 8400043
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Investigational Site Number 8400034
    • Monroe, Louisiana, United States, 71203
      • Investigational Site Number 8400079
    • New Orleans, Louisiana, United States, 70112
      • Investigational Site Number 8400013
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • Investigational Site Number 8400047
  • Michigan
    • Flint, Michigan, United States, 48504
      • Investigational Site Number 8400001
    • Flint, Michigan, United States, 48532-3447
      • Investigational Site Number 8400061
    • Troy, Michigan, United States, 48085
      • Investigational Site Number 8400010
    • Troy, Michigan, United States, 48098
      • Investigational Site Number 8400005
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Investigational Site Number 8400024
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • Investigational Site Number 8400045
  • Montana
    • Billings, Montana, United States, 59103
      • Investigational Site Number 8400071
    • Great Falls, Montana, United States, 59405-4507
      • Investigational Site Number 8400028
    • Kalispell, Montana, United States, 59901
      • Investigational Site Number 8400086
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Investigational Site Number 8400037
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Investigational Site Number 8400087
  • New York
    • Bronx, New York, United States, 00000
      • Investigational Site Number 8400018
    • Staten Island, New York, United States, 10301
      • Investigational Site Number 8400056
  • North Carolina
    • Greenville, North Carolina, United States, 27834-5704
      • Investigational Site Number 8400076
    • Morehead City, North Carolina, United States, 28557
      • Investigational Site Number 8400007
    • Morehead City, North Carolina, United States, 28557
      • Investigational Site Number 8400093
    • Morganton, North Carolina, United States, 28655
      • Investigational Site Number 8400094
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Investigational Site Number 8400029
  • Ohio
    • Columbus, Ohio, United States, 43203
      • Investigational Site Number 8400031
    • Lorain, Ohio, United States, 44053
      • Investigational Site Number 8400078
  • Oregon
    • Bend, Oregon, United States, 97702
      • Investigational Site Number 8400072
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009-1957
      • Investigational Site Number 8400067
    • Philadelphia, Pennsylvania, United States, 19107
      • Investigational Site Number 8400096
    • Pittsburgh, Pennsylvania, United States, 15212
      • Investigational Site Number 8400021
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Investigational Site Number 8400015
    • Murrells Inlet, South Carolina, United States, 29576
      • Investigational Site Number 8400063
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Investigational Site Number 8400044
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • Investigational Site Number 8400016
    • Nashville, Tennessee, United States, 37203
      • Investigational Site Number 8400009
  • Texas
    • Corpus Christi, Texas, United States, 78814
      • Investigational Site Number 8400055
    • Dallas, Texas, United States, 75230
      • Investigational Site Number 8400097
    • El Paso, Texas, United States, 79935
      • Investigational Site Number 8400088
    • Fort Worth, Texas, United States, 76132
      • Investigational Site Number 8400058
    • Houston, Texas, United States, 77004
      • Investigational Site Number 8400069
    • Houston, Texas, United States, 77030
      • Investigational Site Number 8400089
    • Richmond, Texas, United States, 77469
      • Investigational Site Number 8400092
    • Waco, Texas, United States, 76710
      • Investigational Site Number 8400033
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Investigational Site Number 8400039
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Investigational Site Number 8400052
  • Wisconsin
    • Manitowoc, Wisconsin, United States, 54220
      • Investigational Site Number 8400049

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment.	Drug: Placebo; Pharmaceutical form: Solution for injection Route of administration: SC
Experimental: Efpeglenatide 4 mg; Participants received Efpeglenatide as SC injection 2 milligrams (mg) per week for 4 weeks then 4 mg per week up to end of treatment.	Drug: Efpeglenatide (SAR439977); Pharmaceutical form: Solution for injection, Route of administration: SC
Experimental: Efpeglenatide 6 mg; Participants 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.	Drug: Efpeglenatide (SAR439977); Pharmaceutical form: Solution for injection, Route of administration: SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
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.	From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
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.	From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Hanmi Pharmaceutical Company Limited

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2018
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Efpeglenatide
• Other Study ID Numbers: EFC14828; 2017-002954-35 (EudraCT Number); U1111-1186-2533 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share individual participant data (IPD) by Sanofi: product rights transferred to Hanmi pharmaceutical.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No