Effect of Efpeglenatide on Cardiovascular Outcomes

PHASE3TerminatedINTERVENTIONAL
Enrollment

4,076

Participants

Timeline

Start Date

April 27, 2018

Primary Completion Date

December 10, 2020

Study Completion Date

December 10, 2020

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Efpeglenatide (SAR439977)

"Pharmaceutical form: Solution for injection,~Route of administration: SC"

DRUG

Placebo

"Pharmaceutical form: Solution for injection~Route of administration: SC"

Trial Locations (353)

1036

Investigational Site Number 3480011, Budapest

1042

Investigational Site Number 3480003, Budapest

1106

Investigational Site Number 3480005, Budapest

1120

Investigational Site Number 0320002, Caba

1122

Investigational Site Number 3480001, Budapest

1134

Investigational Site Number 3480006, Budapest

1233

Investigational Site Number 1000003, Sofia

1425

Investigational Site Number 0320010, Caba

1430

Investigational Site Number 0320009, Buenos Aires

1431

Investigational Site Number 1000001, Sofia

1750

Investigational Site Number 1000005, Sofia

1752

Investigational Site Number 7100003, Johannesburg

2000

Investigational Site Number 0320015, Rosario

2128

Investigational Site Number 7100004, Rivonia

2198

Investigational Site Number 7100001, Johannesburg

2317

Investigational Site Number 5780002, Hamar

2400

Investigational Site Number 2080002, København NV

2650

Investigational Site Number 2080003, Hvidovre

2700

Investigational Site Number 1000011, Blagoevgrad

2900

Investigational Site Number 2080001, Hellerup

Investigational Site Number 3480009, Komárom

4000

Investigational Site Number 1000008, Plovdiv

4002

Investigational Site Number 1000002, Plovdiv

4011

Investigational Site Number 5780003, Stavanger

4032

Investigational Site Number 3480002, Debrecen

4400

Investigational Site Number 0320003, Salta

Investigational Site Number 0320018, Salta

5300

Investigational Site Number 1000017, Gabrovo

5500

Investigational Site Number 1000010, Lovech

6000

Investigational Site Number 1000006, Stara Zagora

6100

Investigational Site Number 1000007, Kazanlak

6700

Investigational Site Number 2080005, Esbjerg

7002

Investigational Site Number 1000012, Rousse

7130

Investigational Site Number 7100005, Cape Town

7500

Investigational Site Number 7100002, Parow

8000

Investigational Site Number 3480007, Székesfehérvár

8200

Investigational Site Number 2080004, Aarhus N

8230

Investigational Site Number 3480012, Balatonfüred

8600

Investigational Site Number 1000016, Yambol

8900

Investigational Site Number 3480004, Zalaegerszeg

9000

Investigational Site Number 1000009, Varna

9200

Investigational Site Number 3480008, Mosonmagyaróvár

9301

Investigational Site Number 7100007, Bloemfontein

10301

Investigational Site Number 8400056, Staten Island

10437

Investigational Site Number 2760006, Berlin

11000

Investigational Site Number 6880001, Belgrade

Investigational Site Number 6880002, Belgrade

11050

Investigational Site Number 6880003, Belgrade

Investigational Site Number 6880005, Belgrade

11923

Investigational Site Number 4100006, Guri-si

12627

Investigational Site Number 2760009, Berlin

13419

Investigational Site Number 2330001, Tallinn

15212

Investigational Site Number 8400021, Pittsburgh

16059

Investigational Site Number 7920002, Bursa

17800

Investigational Site Number 7240005, Olot

18014

Investigational Site Number 7240007, Granada

19107

Investigational Site Number 8400096, Philadelphia

20000

Investigational Site Number 6040002, Piura

20132

Investigational Site Number 3800001, Milan

20230

Investigational Site Number 4840007, Aguascalientes

Investigational Site Number 4840009, Aguascalientes

Investigational Site Number 4840013, Aguascalientes

20745

Investigational Site Number 8400047, Oxon Hill

21000

Investigational Site Number 6880006, Novi Sad

21001

Investigational Site Number 8040005, Vinnytsia

23510

Investigational Site Number 8400052, Norfolk

23758

Investigational Site Number 2760003, Oldenburg in Holstein

26040

Investigational Site Number 7920013, Eskişehir

26426

Investigational Site Number 4100008, Wŏnju

28023

Investigational Site Number 7240010, Madrid

28040

Investigational Site Number 7240001, Madrid

28222

Investigational Site Number 7240006, Majadahonda

28557

Investigational Site Number 8400007, Morehead City

Investigational Site Number 8400093, Morehead City

28655

Investigational Site Number 8400094, Morganton

28702

Investigational Site Number 7240003, San Sebastián de los Reyes

28922

Investigational Site Number 7240008, Alcorcón

29010

Investigational Site Number 7240011, Málaga

29576

Investigational Site Number 8400063, Murrells Inlet

29651

Investigational Site Number 8400015, Greer

30076

Investigational Site Number 8400008, Roswell

31000

Investigational Site Number 4840014, Chihuahua City

32174

Investigational Site Number 8400059, Ormond Beach

32204

Investigational Site Number 8400011, Jacksonville

Investigational Site Number 8400017, Jacksonville

32277

Investigational Site Number 8400042, Jacksonville

33012

Investigational Site Number 8400091, Hialeah

33024

Investigational Site Number 8400040, Hollywood

33126

Investigational Site Number 8400027, Miami

33136

Investigational Site Number 8400051, Miami

34000

Investigational Site Number 4840016, Durango

Investigational Site Number 6880004, Kragujevac

34080

Investigational Site Number 4840015, Durango

34393

Investigational Site Number 7920001, Istanbul

34652

Investigational Site Number 8400041, New Port Richey

34667

Investigational Site Number 8400073, Hudson

34843

Investigational Site Number 7920006, Istanbul

35660

Investigational Site Number 8400032, Sheffield

36199

Investigational Site Number 2760007, Rotenburg an der Fulda

37203

Investigational Site Number 8400009, Nashville

38163

Investigational Site Number 8400016, Memphis

40361

Investigational Site Number 8400043, Paris

40620

Investigational Site Number 2460001, Jyväskylä

41014

Investigational Site Number 7240013, Seville

41345

Investigational Site Number 7520006, Gothenburg

41380

Investigational Site Number 7920011, İzmit

42303

Investigational Site Number 8400077, Owensboro

42500

Investigational Site Number 4840004, Actopan

43040

Investigational Site Number 7920014, Kütahya

43203

Investigational Site Number 8400031, Columbus

44053

Investigational Site Number 8400078, Lorain

44210

Investigational Site Number 4840006, Guadalajara

44600

Investigational Site Number 4840003, Guadalajara

44650

Investigational Site Number 4840005, Guadalajara

45355

Investigational Site Number 2760004, Essen

46000

Investigational Site Number 8040004, Ternopil

46010

Investigational Site Number 7240004, Valencia

46026

Investigational Site Number 7240014, Valencia

46113

Investigational Site Number 8400030, New Albany

48085

Investigational Site Number 8400010, Troy

48098

Investigational Site Number 8400005, Troy

48145

Investigational Site Number 2760005, Münster

48504

Investigational Site Number 8400001, Flint

49005

Investigational Site Number 8040006, Dnipro

49241

Investigational Site Number 4100007, Busan

49449

Investigational Site Number 4400001, Kaunas

50161

Investigational Site Number 4400002, Kaunas

54220

Investigational Site Number 8400049, Manitowoc

55102

Investigational Site Number 8400024, Saint Paul

55139

Investigational Site Number 7920007, Samsun

57702

Investigational Site Number 8400044, Rapid City

58104

Investigational Site Number 8400029, Fargo

58140

Investigational Site Number 7920009, Sivas

59103

Investigational Site Number 8400071, Billings

59901

Investigational Site Number 8400086, Kalispell

60005

Investigational Site Number 8400095, Arlington Heights

60012

Investigational Site Number 8400036, Crystal Lake

60313

Investigational Site Number 2760008, Frankfurt am Main

60607

Investigational Site Number 8400070, Chicago

61124

Investigational Site Number 8040003, Kharkiv

61166

Investigational Site Number 8040002, Kharkiv

62250

Investigational Site Number 4840002, Cuernavaca

63136

Investigational Site Number 8400045, St Louis

64020

Investigational Site Number 4840011, Monterrey

64060

Investigational Site Number 4840010, Monterrey

64460

Investigational Site Number 4840001, Monterrey

66013

Investigational Site Number 3800002, Chieti

66606

Investigational Site Number 8400074, Topeka

70100

Investigational Site Number 2460003, Kuopio

70112

Investigational Site Number 8400013, New Orleans

71024

Investigational Site Number 2330003, Viljandi

71203

Investigational Site Number 8400079, Monroe

71301

Investigational Site Number 8400034, Alexandria

75230

Investigational Site Number 8400097, Dallas

76008

Investigational Site Number 8040009, Ivano-Frankivsk

76018

Investigational Site Number 8040001, Ivano-Frankivsk

76132

Investigational Site Number 8400058, Fort Worth

76710

Investigational Site Number 8400033, Waco

77004

Investigational Site Number 8400069, Houston

77030

Investigational Site Number 8400089, Houston

77469

Investigational Site Number 8400092, Richmond

78814

Investigational Site Number 8400055, Corpus Christi

79935

Investigational Site Number 8400088, El Paso

80018

Investigational Site Number 2330002, Pärnu

80113

Investigational Site Number 8400064, Englewood

83404

Investigational Site Number 8400081, Idaho Falls

84102

Investigational Site Number 8400039, Salt Lake City

85101

Investigational Site Number 7030007, Bratislava

85295

Investigational Site Number 8400014, Gilbert

85374

Investigational Site Number 8400012, Surprise

85745

Investigational Site Number 8400046, Tucson

88100

Investigational Site Number 3800003, Catanzaro

Investigational Site Number 3800005, Catanzaro

89128

Investigational Site Number 8400037, Las Vegas

90201

Investigational Site Number 7030010, Pezinok

90211

Investigational Site Number 8400022, Beverly Hills

90220

Investigational Site Number 2460004, Oulu

90807

Investigational Site Number 8400084, Long Beach

91101

Investigational Site Number 7030012, Trenčín

91325

Investigational Site Number 8400085, Northridge

91767

Investigational Site Number 8400082, Pomona

92111

Investigational Site Number 4400003, Klaipėda

94520

Investigational Site Number 8400065, Concord

94904

Investigational Site Number 8400060, Greenbrae

95032

Investigational Site Number 8400002, Los Gatos

95123

Investigational Site Number 3800006, Catania

95821

Investigational Site Number 8400025, Sacramento

97702

Investigational Site Number 8400072, Bend

100561

Investigational Site Number 6420008, Ploieşti

110060

Investigational Site Number 3560009, New Delhi

111539

Investigational Site Number 6430004, Moscow

117292

Investigational Site Number 6430005, Moscow

121374

Investigational Site Number 6430002, Moscow

121552

Investigational Site Number 6430015, Moscow

122001

Investigational Site Number 3560002, Gūrgaon

143408

Investigational Site Number 6430017, Krasnogorsk

190013

Investigational Site Number 6430006, Saint Petersburg

193312

Investigational Site Number 6430010, Saint Petersburg

Investigational Site Number 6430011, Saint Petersburg

194156

Investigational Site Number 6430013, Saint Petersburg

195067

Investigational Site Number 6430016, Saint Petersburg

198205

Investigational Site Number 6430012, Saint Petersburg

226002

Investigational Site Number 3560006, Lucknow

236035

Investigational Site Number 6430018, Kaliningrad

410028

Investigational Site Number 6430003, Saratov

410039

Investigational Site Number 6430020, Saratov

410151

Investigational Site Number 6420012, Oradea

410159

Investigational Site Number 6420005, Oradea

410169

Investigational Site Number 6420010, Oradea

411001

Investigational Site Number 3560010, Pune

411010

Investigational Site Number 3560005, Pune

420087

Investigational Site Number 6430014, Kazan'

500097

Investigational Site Number 6420001, Brasov

500365

Investigational Site Number 6420011, Brasov

540142

Investigational Site Number 6420002, Târgu Mureş

Investigational Site Number 6420003, Târgu Mureş

590010

Investigational Site Number 3560001, Belagavi

600154

Investigational Site Number 6420007, Bacau

630055

Investigational Site Number 6430009, Novosibirsk

630087

Investigational Site Number 6430019, Novosibirsk

632004

Investigational Site Number 3560004, Vellore

650002

Investigational Site Number 6430001, Kemerovo

700073

Investigational Site Number 3560007, Kolkata

1270013

Investigational Site Number 1520012, Antofagasta

4070566

Investigational Site Number 1520008, Concepción

4813299

Investigational Site Number 1520006, Temuco

7500571

Investigational Site Number 1520013, Santiago

7500710

Investigational Site Number 1520002, Santiago

Investigational Site Number 1520007, Santiago

7770086

Investigational Site Number 1520011, Santiago

8053095

Investigational Site Number 1520010, Santiago

8330336

Investigational Site Number 1520001, Santiago

8380456

Investigational Site Number 1520003, Santiago

8900132

Investigational Site Number 1520014, Santiago

06517

Investigational Site Number 8400019, Hamden

06708-3346

Investigational Site Number 8400023, Waterbury

31210-1359

Investigational Site Number 8400006, Macon

48532-3447

Investigational Site Number 8400061, Flint

59405-4507

Investigational Site Number 8400028, Great Falls

08869

Investigational Site Number 8400087, Raritan

00000

Investigational Site Number 8400018, The Bronx

27834-5704

Investigational Site Number 8400076, Greenville

15009-1957

Investigational Site Number 8400067, Beaver

1425DES

Investigational Site Number 0320013, Caba

C1119ACN

Investigational Site Number 0320005, Caba

C1056ABJ

Investigational Site Number 0320008, Capital Federal

C1179AAB

Investigational Site Number 0320001, Capital Federal

W3400AMZ

Investigational Site Number 0320004, Corrientes

W3410AVV

Investigational Site Number 0320012, Corrientes

M5501ARP

Investigational Site Number 0320011, Godoy Cruz

B7600FZN

Investigational Site Number 0320007, Mar del Plata

B1722COV

Investigational Site Number 0320006, Merlo

S2002OJP

Investigational Site Number 0320017, Rosario

B1642DCB

Investigational Site Number 0320016, San Isidro

Unknown

Investigational Site Number 0320014, Santa Rosa

Investigational Site Number 1000014, Dimitrovgrad

Investigational Site Number 1000013, Kyustendil

Investigational Site Number 1520005, Santiago

Investigational Site Number 1520004, Viña del Mar

Investigational Site Number 5780001, Oslo

Investigational Site Number 6040001, Lima

Investigational Site Number 6040005, Lima

Investigational Site Number 7100006, Cape Town

Investigational Site Number 7100008, Umhlanga Rocks Suburb

L4N 7L3

Investigational Site Number 1240001, Barrie

L6S 0C6

Investigational Site Number 1240002, Brampton

L7M 1K9

Investigational Site Number 1240018, Burlington

L7R 1E2

Investigational Site Number 1240021, Burlington

T2H 2G4

Investigational Site Number 1240007, Calgary

T2V 4J2

Investigational Site Number 1240020, Calgary

G7H 7K9

Investigational Site Number 1240024, Chicoutimi

L4K 4M2

Investigational Site Number 1240004, Concord

M9R 4E1

Investigational Site Number 1240005, Etobicoke

P3E 4H5

Investigational Site Number 1240022, Greater Sudbury

G6W 0M5

Investigational Site Number 1240011, Lévis

N5W 6A2

Investigational Site Number 1240025, London

N6A 5R8

Investigational Site Number 1240028, London

J7J 2K8

Investigational Site Number 1240029, Mirabel

H1M 1B1

Investigational Site Number 1240008, Montreal

H1T 1C8

Investigational Site Number 1240031, Montreal

H4A 2C6

Investigational Site Number 1240014, Montreal

H4A 3T2

Investigational Site Number 1240023, Montreal

H4N 2W2

Investigational Site Number 1240017, Montreal

L6M 1M1

Investigational Site Number 1240015, Oakville

L1J 2K1

Investigational Site Number 1240012, Oshawa

K2J 0V2

Investigational Site Number 1240030, Ottawa

K9J 0B2

Investigational Site Number 1240027, Peterborough

H9R 4S3

Investigational Site Number 1240016, Pointe-Claire

G1N 4V3

Investigational Site Number 1240010, Québec

T4N 6V7

Investigational Site Number 1240019, Red Deer

J1L 0H8

Investigational Site Number 1240006, Sherbrooke

M4G 3E8

Investigational Site Number 1240013, Toronto

V5Y 3W2

Investigational Site Number 1240003, Vancouver

V8V 4A1

Investigational Site Number 1240026, Victoria

G6P 6P6

Investigational Site Number 1240009, Victoriaville

00100

Investigational Site Number 2460002, Helsinki

01796

Investigational Site Number 2760002, Pirna

110 029

Investigational Site Number 3560003, New Delhi

00133

Investigational Site Number 3800004, Roma

LV-5417

Investigational Site Number 4280004, Daugavpils

LV3414

Investigational Site Number 4280002, Liepāja

LV-1011

Investigational Site Number 4280001, Riga

LV-2150

Investigational Site Number 4280003, Sigulda

08661

Investigational Site Number 4400004, Vilnius

LIMA 01

Investigational Site Number 6040007, Lima

LIMA 11

Investigational Site Number 6040004, Lima

LIMA 27

Investigational Site Number 6040003, Lima

LIMA 31

Investigational Site Number 6040006, Lima

15-404

Investigational Site Number 6160017, Bialystok

80-095

Investigational Site Number 6160018, Bydgoszcz

85-090

Investigational Site Number 6160015, Bydgoszcz

80-546

Investigational Site Number 6160016, Gdansk

80-858

Investigational Site Number 6160012, Gdansk

40-530

Investigational Site Number 6160005, Katowice

09-402

Investigational Site Number 6160006, Płock

96-100

Investigational Site Number 6160011, Skierniewice

60-185

Investigational Site Number 6160013, Skorzewo

70-506

Investigational Site Number 6160010, Szczecin

87-100

Investigational Site Number 6160007, Torun

Investigational Site Number 6160009, Torun

43-100

Investigational Site Number 6160014, Tychy

02-507

Investigational Site Number 6160002, Warsaw

50-315

Investigational Site Number 6160004, Wroclaw

020475

Investigational Site Number 6420009, Bucharest

040 01

Investigational Site Number 7030001, Košice

Investigational Site Number 7030004, Košice

077 01

Investigational Site Number 7030003, Kráľovský Chlmec

04525

Investigational Site Number 7030009, Moldava nad Bodvou

01701

Investigational Site Number 7030006, Považská Bystrica

080 01

Investigational Site Number 7030005, Prešov

04801

Investigational Site Number 7030008, Rožňava

943 01

Investigational Site Number 7030011, Štúrovo

075 01

Investigational Site Number 7030002, Trebišov

02841

Investigational Site Number 4100005, Seoul

03080

Investigational Site Number 4100002, Seoul

03181

Investigational Site Number 4100009, Seoul

03722

Investigational Site Number 4100001, Seoul

06351

Investigational Site Number 4100011, Seoul

06591

Investigational Site Number 4100003, Seoul

08308

Investigational Site Number 4100010, Seoul

08035

Investigational Site Number 7240002, Barcelona

08041

Investigational Site Number 7240009, Barcelona

252 20

Investigational Site Number 7520003, Helsingborg

291 85

Investigational Site Number 7520004, Kristianstad

211 52

Investigational Site Number 7520002, Malmo

541 40

Investigational Site Number 7520005, Skövde

171 76

Investigational Site Number 7520001, Stockholm

01250

Investigational Site Number 7920005, Adana

06490

Investigational Site Number 7920010, Ankara

07070

Investigational Site Number 7920012, Antalya

09100

Investigational Site Number 7920015, Aydin

02091

Investigational Site Number 8040007, Kiev

01004

Investigational Site Number 8040008, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hanmi Pharmaceutical Company Limited

INDUSTRY

lead

Sanofi

INDUSTRY