Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

954

Participants

Timeline

Start Date

December 1, 2017

Primary Completion Date

August 6, 2019

Study Completion Date

September 6, 2019

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sotagliflozin (SAR439954)

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

DRUG

Glimepiride

"Pharmaceutical form: capsule~Route of administration: oral"

DRUG

Metformin

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

DRUG

Placebo

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

DRUG

Placebo

"Pharmaceutical form: capsule~Route of administration: oral"

Trial Locations (142)

1033

Investigational Site Number 3487001, Budapest

1134

Investigational Site Number 3487010, Budapest

1632

Investigational Site Number 1007009, Sofia

4000

Investigational Site Number 1007008, Plovdiv

4002

Investigational Site Number 1007003, Plovdiv

4014

Investigational Site Number 7037005, Košice

4025

Investigational Site Number 3487006, Debrecen

4032

Investigational Site Number 3487008, Debrecen

4400

Investigational Site Number 3487004, Nyíregyháza

4405

Investigational Site Number 3487007, Nyíregyháza

4700

Investigational Site Number 1007004, Smolyan

5300

Investigational Site Number 1007002, Gabrovo

6000

Investigational Site Number 1007005, Stara Zagora

Investigational Site Number 1007006, Stara Zagora

Investigational Site Number 3487002, Kecskemét

7003

Investigational Site Number 1007001, Rousse

8230

Investigational Site Number 3487005, Balatonfüred

9000

Investigational Site Number 1007007, Varna

10029

Investigational Site Number 8407086, New York

10036

Investigational Site Number 8407122, New York

14224

Investigational Site Number 8407123, West Seneca

20852

Investigational Site Number 8407001, Rockville

21237

Investigational Site Number 8407085, Baltimore

27103

Investigational Site Number 8407101, Winston-Salem

27408

Investigational Site Number 8407020, Greensboro

28557

Investigational Site Number 8407015, Morehead City

29407

Investigational Site Number 8407016, Charleston

29464

Investigational Site Number 8407022, Mt. Pleasant

Investigational Site Number 8407031, Mt. Pleasant

33024

Investigational Site Number 8407103, Cooper City

33134

Investigational Site Number 8407021, Coral Gables

33401

Investigational Site Number 8407092, West Palm Beach

33467

Investigational Site Number 8407062, Lake Worth

33619

Investigational Site Number 8407091, Tampa

33634

Investigational Site Number 8407113, Tampa

33761

Investigational Site Number 8407027, Clearwater

33880

Investigational Site Number 8407115, Winter Haven

34201

Investigational Site Number 8407074, Bradenton

34609

Investigational Site Number 8407107, Spring Hill

34761

Investigational Site Number 8407121, Ocoee

35205

Investigational Site Number 8407040, Birmingham

37760

Investigational Site Number 8407014, Jefferson City

37938

Investigational Site Number 8407002, Knoxville

38163

Investigational Site Number 8407056, Memphis

38654

Investigational Site Number 8407110, Olive Branch

40503

Investigational Site Number 8407087, Lexington

45245

Investigational Site Number 8407099, Cincinnati

50265

Investigational Site Number 8407120, West Des Moines

50702

Investigational Site Number 8407075, Waterloo

60031

Investigational Site Number 8407046, Gurnee

60124

Investigational Site Number 8407018, Elgin

60607

Investigational Site Number 8407017, Chicago

62711

Investigational Site Number 8407119, Springfield

63044

Investigational Site Number 8407054, Bridgeton

68114

Investigational Site Number 8407039, Omaha

68701

Investigational Site Number 8407049, Norfolk

70119

Investigational Site Number 8407058, New Orleans

70124

Investigational Site Number 8407009, New Orleans

70601

Investigational Site Number 8407060, Lake Charles

72211

Investigational Site Number 8407035, Little Rock

73069

Investigational Site Number 8407057, Norman

75010

Investigational Site Number 8407070, Carrollton

75075

Investigational Site Number 8407007, Plano

75149

Investigational Site Number 8407012, Mesquite

75230

Investigational Site Number 8407023, Dallas

75231

Investigational Site Number 8407111, Dallas

75904

Investigational Site Number 8407067, Lufkin

Investigational Site Number 8407118, Lufkin

76164

Investigational Site Number 8407013, Fort Worth

77040

Investigational Site Number 8407080, Houston

77372

Investigational Site Number 8407076, Splendora

77450

Investigational Site Number 8407090, Katy

77702

Investigational Site Number 8407029, Beaumont

78154

Investigational Site Number 8407010, Schertz

78218

Investigational Site Number 8407005, San Antonio

78504

Investigational Site Number 8407059, McAllen

84015

Investigational Site Number 8407063, Clinton

84405

Investigational Site Number 8407097, Ogden

85101

Investigational Site Number 7037007, Bratislava

87106

Investigational Site Number 8407050, Albuquerque

90242

Investigational Site Number 8407089, Downey

90650

Investigational Site Number 8407094, Norwalk

90717

Investigational Site Number 8407100, Lomita

90806

Investigational Site Number 8407033, Long Beach

91301

Investigational Site Number 8407065, Canoga Park

91405

Investigational Site Number 8407032, Van Nuys

91701

Investigational Site Number 7037003, Trnava

91730

Investigational Site Number 8407096, Rancho Cucamonga

91766

Investigational Site Number 8407106, Pomona

91945

Investigational Site Number 8407037, Lemon Grove

92595

Investigational Site Number 8407117, Wildomar

94598

Investigational Site Number 8407004, Walnut Creek

94901

Investigational Site Number 7037010, Nitra

94904

Investigational Site Number 8407044, Greenbrae

95608

Investigational Site Number 8407078, Carmichael

95670

Investigational Site Number 8407011, Gold River

95821

Investigational Site Number 8407036, Sacramento

97404

Investigational Site Number 8407068, Eugene

98055

Investigational Site Number 8407028, Renton

35233-2110

Investigational Site Number 8407048, Birmingham

92801-2417

Investigational Site Number 8407051, Anaheim

90255-2911

Investigational Site Number 8407006, Huntington Park

90057-3507

Investigational Site Number 8407019, Los Angeles

91325-5409

Investigational Site Number 8407098, Northridge

91356-3551

Investigational Site Number 8407084, Tarzana

91786-4070

Investigational Site Number 8407034, Upland

80920-8075

Investigational Site Number 8407045, Colorado Springs

32825-4454

Investigational Site Number 8407024, Orlando

33157-5503

Investigational Site Number 8407038, Palmetto Bay

33026-3924

Investigational Site Number 8407093, Pembroke Pines

66606-2806

Investigational Site Number 8407095, Topeka

67205-1138

Investigational Site Number 8407083, Wichita

40503-2517

Investigational Site Number 8407043, Lexington

70791-4010

Investigational Site Number 8407079, Zachary

48098-6334

Investigational Site Number 8407069, Troy

68046-3136

Investigational Site Number 8407061, Papillion

89106-4132

Investigational Site Number 8407108, Las Vegas

10016-6402

Investigational Site Number 8407116, New York

28645-8981

Investigational Site Number 8407114, Lenoir

28144-2742

Investigational Site Number 8407030, Salisbury

28401-6638

Investigational Site Number 8407041, Wilmington

44124-2467

Investigational Site Number 8407081, Lyndhurst

73104-3252

Investigational Site Number 8407073, Oklahoma City

15009-1957

Investigational Site Number 8407104, Beaver

19040-2045

Investigational Site Number 8407025, Hatboro

19446-1002

Investigational Site Number 8407053, Lansdale

29651-1817

Investigational Site Number 8407071, Greer

78735-8982

Investigational Site Number 8407026, Austin

78414-4173

Investigational Site Number 8407102, Corpus Christi

77095-2856

Investigational Site Number 8407088, Houston

76550-1820

Investigational Site Number 8407042, Lampasas

78229-3818

Investigational Site Number 8407064, San Antonio

84117-7054

Investigational Site Number 8407055, Holladay

84102-1553

Investigational Site Number 8407072, Salt Lake City

20110-4421

Investigational Site Number 8407124, Manassas

23249-0001

Investigational Site Number 8407105, Richmond

085 01

Investigational Site Number 7037004, Bardejov

831 06

Investigational Site Number 7037008, Bratislava

934 01

Investigational Site Number 7037002, Levice

048 01

Investigational Site Number 7037009, Rožňava

08301

Investigational Site Number 7037001, Sabinov

038 61

Investigational Site Number 7037006, Vrútky

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY