Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

399

Participants

Timeline

Start Date

November 11, 2016

Primary Completion Date

April 22, 2019

Study Completion Date

May 17, 2019

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sotagliflozin (SAR439954)

"Pharmaceutical form: tablet;~Route of administration: oral"

DRUG

Placebo

"Pharmaceutical form: tablet;~Route of administration: oral"

Trial Locations (70)

11410

Investigational Site Number 4841003, Cd. México, México

11850

Investigational Site Number 4841007, México

19056

Investigational Site Number 8401041, Levittown

20230

Investigational Site Number 4841006, Aguascalientes

Investigational Site Number 4841010, Aguascalientes

27401

Investigational Site Number 8401012, Greensboro

28314

Investigational Site Number 8401042, Fayetteville

29621

Investigational Site Number 8401051, Anderson

29651

Investigational Site Number 8401002, Greer

30303

Investigational Site Number 8401033, Atlanta

31200

Investigational Site Number 4841004, Chihuahua City

32117

Investigational Site Number 8401014, Daytona Beach

32825

Investigational Site Number 8401053, Orlando

33012

Investigational Site Number 8401007, Hialeah

33030

Investigational Site Number 8401046, Homestead

33135

Investigational Site Number 8401018, Miami

33185

Investigational Site Number 8401008, Miami

33756

Investigational Site Number 8401040, Clearwater

34080

Investigational Site Number 4841005, Durango, Durango

34201

Investigational Site Number 8401024, Bradenton

34684

Investigational Site Number 8401062, Palm Harbor

43302

Investigational Site Number 8401003, Marion

44311

Investigational Site Number 8401048, Akron

44600

Investigational Site Number 4841009, Guadalajara

50208

Investigational Site Number 8401052, Newton

50265

Investigational Site Number 8401016, West Des Moines

60602

Investigational Site Number 8401044, Chicago

64020

Investigational Site Number 4841008, Monterrey

64460

Investigational Site Number 4841002, Monterrey, Nuevo León

70601

Investigational Site Number 8401038, Lake Charles

76164

Investigational Site Number 8401005, Fort Worth

76180

Investigational Site Number 8401059, North Richland Hills

77081

Investigational Site Number 8401019, Houston

77099

Investigational Site Number 8401050, Houston

77450

Investigational Site Number 8401037, Katy

77478

Investigational Site Number 8401023, Sugar Land

78154

Investigational Site Number 8401055, Schertz

78218

Investigational Site Number 8401004, San Antonio

78229

Investigational Site Number 8401054, San Antonio

78231

Investigational Site Number 8401001, San Antonio

78504

Investigational Site Number 8401043, McAllen

80220

Investigational Site Number 8401031, Denver

80230

Investigational Site Number 4841001, Culiacán

80234

Investigational Site Number 8401060, Northglenn

85741

Investigational Site Number 8401049, Tucson

85745

Investigational Site Number 8401026, Tucson

90036

Investigational Site Number 8401063, Los Angeles

90057

Investigational Site Number 8401011, Los Angeles

90255

Investigational Site Number 8401017, Huntington Park

90650

Investigational Site Number 8401039, Norwalk

90716

Investigational Site Number 8401029, Hawaiian Gardens

90806

Investigational Site Number 8401056, Long Beach

90807

Investigational Site Number 8401013, Long Beach

91303

Investigational Site Number 8401057, Canoga Park

91405

Investigational Site Number 8401015, Van Nuys

91713

Investigational Site Number 8401035, San Dimas

91763

Investigational Site Number 8401022, Montclair

92780

Investigational Site Number 8401025, Tustin

92801

Investigational Site Number 8401028, Anaheim

97330

Investigational Site Number 8401020, Corvallis

97404

Investigational Site Number 8401006, Eugene

92844-2751

Investigational Site Number 8401058, Garden Grove

33406-5854

Investigational Site Number 8401061, West Palm Beach

67205-1138

Investigational Site Number 8401034, Wichita

23321-5205

Investigational Site Number 8401032, Chesapeake

23435-3763

Investigational Site Number 8401010, Suffolk

J1L 0H8

Investigational Site Number 1241002, Sherbrooke

M3M 3E5

Investigational Site Number 1241005, Toronto

M9W 4L6

Investigational Site Number 1241001, Toronto

V5X 0C4

Investigational Site Number 1241006, Vancouver

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY