Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

PHASE3CompletedINTERVENTIONAL
Enrollment

514

Participants

Timeline

Start Date

July 6, 2016

Primary Completion Date

May 25, 2018

Study Completion Date

November 17, 2018

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Insulin glargine/lixisenatide fixed ratio combination

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

liraglutide

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

exenatide

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

exenatide extended-release

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

albiglutide

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

dulaglutide

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)

Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.

Trial Locations (124)

10001

Investigational Site Number 8400061, New York

10138

Investigational Site Number 2330003, Tallinn

10301

Investigational Site Number 8400095, Staten Island

10704

Investigational Site Number 8400111, Yonkers

11758

Investigational Site Number 8400123, North Massapequa

12206

Investigational Site Number 8400079, Albany

13419

Investigational Site Number 2330001, Tallinn

14224

Investigational Site Number 8400067, West Seneca

15405

Investigational Site Number 7240002, Ferrol

15478

Investigational Site Number 8400076, Smithfield

15683

Investigational Site Number 8400129, Scottdale

20132

Investigational Site Number 3800001, Milan

20142

Investigational Site Number 3800006, Milan

21237

Investigational Site Number 8400033, Baltimore

23758

Investigational Site Number 2760003, Oldenburg in Holstein

24127

Investigational Site Number 3800008, Bergamo

24290

Investigational Site Number 8400092, Weber City

28223

Investigational Site Number 7240011, Pozuelo de Alarcón

28401

Investigational Site Number 8400065, Wilmington

28557

Investigational Site Number 8400020, Morehead City

29010

Investigational Site Number 7240008, Málaga

29204

Investigational Site Number 8400090, Columbia

30046

Investigational Site Number 8400045, Lawrenceville

30078

Investigational Site Number 8400096, Snellville

31096

Investigational Site Number 3760001, Haifa

32216

Investigational Site Number 8400114, Jacksonville

33165

Investigational Site Number 8400133, Miami

33401

Investigational Site Number 8400112, West Palm Beach

33612

Investigational Site Number 8400084, Tampa

33952

Investigational Site Number 8400058, Port Charlotte

35152

Investigational Site Number 3760002, Haifa

35205

Investigational Site Number 8400064, Birmingham

40138

Investigational Site Number 3800002, Bologna

40503

Investigational Site Number 8400034, Lexington

Investigational Site Number 8400091, Lexington

41003

Investigational Site Number 7240007, Seville

41010

Investigational Site Number 7240009, Seville

41071

Investigational Site Number 7240004, Seville

43201

Investigational Site Number 8400019, Columbus

44060

Investigational Site Number 8400125, Mentor

45439

Investigational Site Number 8400056, Dayton

46123

Investigational Site Number 8400049, Avon

Investigational Site Number 8400053, Avon

Investigational Site Number 8400085, Avon

Investigational Site Number 8400120, Avon

46600

Investigational Site Number 7240012, Alzira

46930

Investigational Site Number 7240003, Quart de Poblet

47714

Investigational Site Number 8400041, Evansville

51501

Investigational Site Number 8400130, Council Bluffs

58104

Investigational Site Number 8400018, Fargo

62711

Investigational Site Number 8400023, Springfield

65109

Investigational Site Number 8400051, Jefferson City

70006

Investigational Site Number 8400032, Metairie

70072

Investigational Site Number 8400078, Marrero

70121

Investigational Site Number 8400088, New Orleans

71024

Investigational Site Number 2330004, Viljandi

73112

Investigational Site Number 8400099, Oklahoma City

76180

Investigational Site Number 8400014, North Richland Hills

77004

Investigational Site Number 8400008, Houston

77040

Investigational Site Number 8400109, Houston

77061

Investigational Site Number 8400063, Houston

77081

Investigational Site Number 8400106, Houston

77478

Investigational Site Number 8400107, Sugar Land

78154

Investigational Site Number 8400135, Schertz

78231

Investigational Site Number 8400075, Shavano Park

78240

Investigational Site Number 8400089, San Antonio

78539

Investigational Site Number 8400118, Edinburg

78749

Investigational Site Number 8400139, Austin

80018

Investigational Site Number 2330002, Pärnu

80131

Investigational Site Number 3800005, Napoli

80209

Investigational Site Number 8400071, Denver

80246

Investigational Site Number 8400036, Denver

84058

Investigational Site Number 8400054, Orem

84102

Investigational Site Number 8400025, Salt Lake City

85028

Investigational Site Number 8400047, Phoenix

85101

Investigational Site Number 7030006, Bratislava

85268

Investigational Site Number 8400073, Fountain Hills

89052

Investigational Site Number 8400044, Henderson

90017

Investigational Site Number 8400098, Los Angeles

90057

Investigational Site Number 8400013, Los Angeles

90101

Investigational Site Number 7030005, Malacky

90255

Investigational Site Number 8400043, Huntington Park

91101

Investigational Site Number 7030004, Trenčín

91120

Investigational Site Number 3760005, Jerusalem

91325

Investigational Site Number 8400006, Northridge

91345

Investigational Site Number 8400042, Mission Hills

92377

Investigational Site Number 8400126, Rialto

92704

Investigational Site Number 8400094, Santa Ana

92868

Investigational Site Number 8400021, Orange

93003

Investigational Site Number 8400009, Ventura

93106

Investigational Site Number 3760006, Jerusalem

93241

Investigational Site Number 8400124, Lamont

93309

Investigational Site Number 8400103, Bakersfield

93534

Investigational Site Number 8400027, Lancaster

93720

Investigational Site Number 8400137, Fresno

98401

Investigational Site Number 7030002, Lučenec

120203

Investigational Site Number 6420008, Buzău

130083

Investigational Site Number 6420009, Târgovişte

300125

Investigational Site Number 6420005, Timișoara

400006

Investigational Site Number 6420003, Cluj-Napoca

410159

Investigational Site Number 6420002, Oradea

500097

Investigational Site Number 6420006, Brasov

540098

Investigational Site Number 6420007, Târgu Mureş

600154

Investigational Site Number 6420004, Bacau

6203854

Investigational Site Number 3760004, Tel Aviv

46254-5469

Investigational Site Number 8400038, Indianapolis

68046-3136

Investigational Site Number 8400083, Papillion

02886

Investigational Site Number 8400104, Warwick

75230-6885

Investigational Site Number 8400001, Dallas

L7M 4Y1

Investigational Site Number 1240003, Burlington

N0N 1G0

Investigational Site Number 1240006, Corunna

T4N 6V7

Investigational Site Number 1240002, Red Deer

V5Y 3W2

Investigational Site Number 1240001, Vancouver

01307

Investigational Site Number 2760001, Dresden

00128

Investigational Site Number 3800004, Roma

00133

Investigational Site Number 3800003, Roma

020045

Investigational Site Number 6420001, Bucharest

034 91

Investigational Site Number 7030009, Ľubochňa

08001

Investigational Site Number 7030007, Prešov

04801

Investigational Site Number 7030001, Rožňava

083 01

Investigational Site Number 7030008, Sabinov

010 01

Investigational Site Number 7030003, Žilina

08035

Investigational Site Number 7240005, Barcelona

08208

Investigational Site Number 7240006, Sabadell

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT02787551 - Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period | Biotech Hunter | Biotech Hunter