Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

PHASE3CompletedINTERVENTIONAL
Enrollment

571

Participants

Timeline

Start Date

September 15, 2017

Primary Completion Date

September 17, 2019

Study Completion Date

September 27, 2019

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sotagliflozin

"Pharmaceutical form: Tablet~Route of administration: Oral"

DRUG

Insulin glargine (HOE901)

"Pharmaceutical form: Solution~Route of administration: Subcutaneous"

DRUG

Placebo

"Pharmaceutical form: Tablet~Route of administration: Oral"

DRUG

Oral Antidiabetes Drugs (OADs)

OADs (including metformin) as prescribed by the investigator as per local labeling.

Trial Locations (106)

1106

Investigational Site Number 3486007, Budapest

1134

Investigational Site Number 3486002, Budapest

1606

Investigational Site Number 1006002, Sofia

1750

Investigational Site Number 1006010, Sofia

2900

Investigational Site Number 3486003, Komárom

3000

Investigational Site Number 3486006, Hatvan

4002

Investigational Site Number 1006003, Plovdiv

4014

Investigational Site Number 7036003, Košice

4400

Investigational Site Number 3486005, Nyíregyháza

4700

Investigational Site Number 1006006, Smolyan

5300

Investigational Site Number 1006009, Gabrovo

6000

Investigational Site Number 1006005, Stara Zagora

Investigational Site Number 3486009, Kecskemét

7002

Investigational Site Number 1006004, Rousse

7003

Investigational Site Number 1006001, Rousse

7623

Investigational Site Number 3486001, Pécs

8900

Investigational Site Number 3486008, Zalaegerszeg

9000

Investigational Site Number 1006007, Varna

11100

Investigational Site Number 2506007, Narbonne

20852

Investigational Site Number 8406024, Rockville

21079

Investigational Site Number 2506005, Dijon

25030

Investigational Site Number 2506008, Besançon

27103

Investigational Site Number 8406019, Winston-Salem

27517

Investigational Site Number 8406046, Chapel Hill

27834

Investigational Site Number 8406038, Greenville

28209

Investigational Site Number 8406026, Charlotte

28601

Investigational Site Number 8406036, Hickory

28803

Investigational Site Number 8406034, Asheville

32720

Investigational Site Number 8406008, DeLand

32751

Investigational Site Number 8406030, Maitland

33134

Investigational Site Number 8406043, Coral Gables

33162

Investigational Site Number 8406029, North Miami Beach

33634

Investigational Site Number 8406025, Tampa

33700

Investigational Site Number 8406022, St. Petersburg

33952

Investigational Site Number 8406001, Port Charlotte

34652

Investigational Site Number 8406003, New Port Richey

34761

Investigational Site Number 8406052, Ocoee

37421

Investigational Site Number 8406009, Chattanooga

43016

Investigational Site Number 8406005, Dublin

43201

Investigational Site Number 8406023, Columbus

44060

Investigational Site Number 8406004, Mentor

44093

Investigational Site Number 2506004, Nantes

44122

Investigational Site Number 8406031, Beachwood

47714

Investigational Site Number 8406042, Evansville

48202

Investigational Site Number 8406016, Detroit

60602

Investigational Site Number 8406054, Chicago

60604

Investigational Site Number 8406027, Chicago

63110

Investigational Site Number 8406011, St Louis

68100

Investigational Site Number 2506012, Mulhouse

69200

Investigational Site Number 2506002, Vénissieux

69495

Investigational Site Number 2506010, Pierre-Bénite

70124

Investigational Site Number 8406051, New Orleans

73111

Investigational Site Number 8406033, Oklahoma City

75018

Investigational Site Number 2506006, Paris

75230

Investigational Site Number 8406047, Dallas

75231

Investigational Site Number 8406017, Dallas

77079

Investigational Site Number 8406048, Houston

77099

Investigational Site Number 8406037, Houston

78229

Investigational Site Number 8406050, San Antonio

78231

Investigational Site Number 8406021, Shavano Park

78504

Investigational Site Number 8406039, McAllen

85018

Investigational Site Number 8406013, Phoenix

85020

Investigational Site Number 8406020, Phoenix

85101

Investigational Site Number 7036001, Bratislava

86021

Investigational Site Number 2506009, Poitiers

90057

Investigational Site Number 8406040, Los Angeles

90255

Investigational Site Number 8406006, Huntington Park

91106

Investigational Site Number 2506003, Corbeil-Essonnes

94160

Investigational Site Number 2506011, Saint-Mandé

95648

Investigational Site Number 8406053, Lincoln

98401

Investigational Site Number 7036011, Lučenec

85213-5226

Investigational Site Number 8406028, Mesa

33401-3430

Investigational Site Number 8406002, West Palm Beach

70119-6302

Investigational Site Number 8406044, New Orleans

68046-3136

Investigational Site Number 8406010, Papillion

10016-6023

Investigational Site Number 8406018, New York

28401-6638

Investigational Site Number 8406015, Wilmington

29461-5017

Investigational Site Number 8406032, Moncks Corner

37865-5270

Investigational Site Number 8406045, Seymour

84102-1553

Investigational Site Number 8406035, Salt Lake City

84088-8865

Investigational Site Number 8406014, West Jordan

L6S 0C9

Investigational Site Number 1246003, Brampton

L7R 1E2

Investigational Site Number 1246005, Burlington

M9R 4E1

Investigational Site Number 1246004, Etobicoke

M4G 3E8

Investigational Site Number 1246002, Toronto

V5Y 3W2

Investigational Site Number 1246001, Vancouver

769 01

Investigational Site Number 2036003, Holešov

794 01

Investigational Site Number 2036002, Krnov

779 00

Investigational Site Number 2036001, Olomouc

702 00

Investigational Site Number 2036005, Ostrava

140 46

Investigational Site Number 2036007, Prague

149 00

Investigational Site Number 2036008, Prague

104 00

Investigational Site Number 2036006, Praha 10 - Uhrineves

085 01

Investigational Site Number 7036004, Bardejov

831 06

Investigational Site Number 7036008, Bratislava

040 01

Investigational Site Number 7036010, Košice

934 01

Investigational Site Number 7036007, Levice

934 05

Investigational Site Number 7036009, Levice

949 11

Investigational Site Number 7036006, Nitra

08301

Investigational Site Number 7036005, Sabinov

DL3 6HX

Investigational Site Number 8266002, Darlington

DN9 2HY

Investigational Site Number 8266006, Doncaster

DD1 9SY

Investigational Site Number 8266008, Dundee

LE5 4PW

Investigational Site Number 8266001, Leicester

EC1M 6BQ

Investigational Site Number 8266004, London

M6 8HD

Investigational Site Number 8266003, Salford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY