Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

February 26, 2019

Study Completion Date

March 22, 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.

DRUG

Metformin

Pharmaceutical form: tablet. Route of administration: oral.

Trial Locations (93)

1033

Investigational Site Number 3482002, Budapest

1088

Investigational Site Number 3482003, Budapest

1213

Investigational Site Number 3482006, Budapest

2500

Investigational Site Number 3482001, Esztergom

4025

Investigational Site Number 3482004, Debrecen

4400

Investigational Site Number 3482007, Nyíregyháza

20852

Investigational Site Number 8402021, Rockville

23454

Investigational Site Number 8402024, Virginia Beach

27401

Investigational Site Number 8402018, Greensboro

28557

Investigational Site Number 8402002, Morehead City

31210

Investigational Site Number 8402008, Macon

32117

Investigational Site Number 8402016, Daytona Beach

32256

Investigational Site Number 8402045, Jacksonville

32825

Investigational Site Number 8402039, Orlando

33012

Investigational Site Number 8402006, Hialeah

Investigational Site Number 8402035, Hialeah

Investigational Site Number 8402044, Hialeah

33054

Investigational Site Number 8402033, Opa-locka

33126

Investigational Site Number 8402026, Miami

33143

Investigational Site Number 8402036, Miami

33183

Investigational Site Number 8402064, Miami

33185

Investigational Site Number 8402007, Miami

33186

Investigational Site Number 8402061, Miami

33472

Investigational Site Number 8402009, Boynton Beach

33880

Investigational Site Number 8402038, Winter Haven

35205

Investigational Site Number 8402003, Birmingham

35294

Investigational Site Number 8402017, Birmingham

40503

Investigational Site Number 8402059, Lexington

50208

Investigational Site Number 8402069, Newton

50265

Investigational Site Number 8402022, West Des Moines

60607

Investigational Site Number 8402054, Chicago

70006

Investigational Site Number 8402012, Metairie

70124

Investigational Site Number 8402053, New Orleans

73104

Investigational Site Number 8402019, Oklahoma City

75115

Investigational Site Number 8402050, DeSoto

75230

Investigational Site Number 8402030, Dallas

76164

Investigational Site Number 8402010, Fort Worth

77008

Investigational Site Number 8402040, Houston

77058

Investigational Site Number 8402065, Houston

77079

Investigational Site Number 8402057, Houston

77355

Investigational Site Number 8402049, Magnolia

78154

Investigational Site Number 8402023, Schertz

78218

Investigational Site Number 8402013, San Antonio

78229

Investigational Site Number 8402004, San Antonio

79761

Investigational Site Number 8402046, Odessa

84015

Investigational Site Number 8402027, Clinton

84107

Investigational Site Number 8402032, Salt Lake City

85018

Investigational Site Number 8402052, Phoenix

89148

Investigational Site Number 8402005, Las Vegas

90022

Investigational Site Number 8402029, Los Angeles

90036

Investigational Site Number 8402041, Los Angeles

90057

Investigational Site Number 8402001, Los Angeles

90255

Investigational Site Number 8402025, Huntington Park

90638

Investigational Site Number 8402051, La Mirada

90807

Investigational Site Number 8402014, Long Beach

Investigational Site Number 8402066, Long Beach

91303

Investigational Site Number 8402056, Canoga Park

91356

Investigational Site Number 8402047, Tarzana

91945

Investigational Site Number 8402042, Lemon Grove

92025

Investigational Site Number 8402020, Escondido

92103

Investigational Site Number 8402043, San Diego

94582

Investigational Site Number 8402031, San Ramon

94904

Investigational Site Number 8402067, Greenbrae

95648

Investigational Site Number 8402011, Lincoln

95670

Investigational Site Number 8402028, Gold River

98105

Investigational Site Number 8402034, Seattle

33140-3608

Investigational Site Number 8402060, Miami Beach

33406-5854

Investigational Site Number 8402063, West Palm Beach

70808-4124

Investigational Site Number 8402068, Baton Rouge

70119-6302

Investigational Site Number 8402037, New Orleans

68114-3755

Investigational Site Number 8402062, Omaha

97404-3233

Investigational Site Number 8402015, Eugene

19446-1002

Investigational Site Number 8402058, Lansdale

L4M 7G1

Investigational Site Number 1242014, Barrie

L6S 0C6

Investigational Site Number 1242004, Brampton

L6T 0G1

Investigational Site Number 1242005, Brampton

L4K 4M2

Investigational Site Number 1242001, Concord

M9R 4E1

Investigational Site Number 1242007, Etobicoke

G6W 0M5

Investigational Site Number 1242010, Lévis

L3Y 5G8

Investigational Site Number 1242012, Newmarket

L6M 1M1

Investigational Site Number 1242013, Oakville

H9R 4S3

Investigational Site Number 1242006, Pointe-Claire

J1L 0H8

Investigational Site Number 1242008, Sherbrooke

M3M 3E5

Investigational Site Number 1242015, Toronto

M4G 3E8

Investigational Site Number 1242002, Toronto

M9W 4L6

Investigational Site Number 1242003, Toronto

V5X 0C4

Investigational Site Number 1242011, Vancouver

851 01

Investigational Site Number 7032001, Bratislava

Investigational Site Number 7032005, Bratislava

901 01

Investigational Site Number 7032003, Malacky

949 11

Investigational Site Number 7032002, Nitra

943 01

Investigational Site Number 7032004, Štúrovo

911 01

Investigational Site Number 7032006, Trenčín

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY