Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

507

Participants

Timeline

Start Date

February 24, 2017

Primary Completion Date

April 17, 2019

Study Completion Date

April 30, 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"

DRUG

Sulfonylurea

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

Trial Locations (76)

1033

Investigational Site Number 3483007, Budapest

1036

Investigational Site Number 3483008, Budapest

Investigational Site Number 3483010, Budapest

1106

Investigational Site Number 3483004, Budapest

1213

Investigational Site Number 3483006, Budapest

1784

Investigational Site Number 1003004, Sofia

1830

Investigational Site Number 4103006, Seoul

2002

Investigational Site Number 8043001, Kyiv

3000

Investigational Site Number 3483009, Hatvan

3037

Investigational Site Number 8043003, Kyiv

3049

Investigational Site Number 8043002, Kyiv

3722

Investigational Site Number 4103010, Seoul

4002

Investigational Site Number 1003003, Plovdiv

5700

Investigational Site Number 3483011, Gyula

6000

Investigational Site Number 3483005, Kecskemét

7002

Investigational Site Number 1003002, Rousse

7345

Investigational Site Number 4103005, Seoul

7623

Investigational Site Number 3483003, Pécs

8001

Investigational Site Number 2333003, Pärnu

8230

Investigational Site Number 3483001, Balatonfüred

8900

Investigational Site Number 3483012, Zalaegerszeg

10380

Investigational Site Number 4103001, Goyang-Si, Gyeonggi-Do

11923

Investigational Site Number 4103011, Guri-Si, Gyeonggi-Do

13620

Investigational Site Number 4103003, Seongnam-Si, Gyeonggi-Do

19040

Investigational Site Number 8403033, Hatboro

22015

Investigational Site Number 8403005, Burke

26426

Investigational Site Number 4103009, Wonju-Si, Gangwon-Do

27408

Investigational Site Number 8403028, Greensboro

28150

Investigational Site Number 8403015, Shelby

32810

Investigational Site Number 8403032, Orlando

33026

Investigational Site Number 8403006, Pembroke Pines

33162

Investigational Site Number 8403020, North Miami Beach

33952

Investigational Site Number 8403013, Port Charlotte

34201

Investigational Site Number 8403029, Bradenton

34652

Investigational Site Number 8403004, New Port Richey

34684

Investigational Site Number 8403008, Palm Harbor

34761

Investigational Site Number 8403026, Ocoee

37660

Investigational Site Number 8403030, Kingsport

48532

Investigational Site Number 8403011, Flint

55432

Investigational Site Number 8403025, Richfield

60702

Investigational Site Number 6163002, Poznan

75230

Investigational Site Number 8403002, Dallas

77081

Investigational Site Number 8403022, Houston

80234

Investigational Site Number 8403001, Northglenn

83686

Investigational Site Number 8403007, Nampa

85340

Investigational Site Number 8403003, Litchfield Park

85381

Investigational Site Number 8403018, Peoria

89014

Investigational Site Number 8403021, Henderson

90057

Investigational Site Number 8403019, Los Angeles

90255

Investigational Site Number 8403012, Huntington Park

91763

Investigational Site Number 8403034, Montclair

91978

Investigational Site Number 8403016, Spring Valley

92780

Investigational Site Number 8403014, Tustin

94904

Investigational Site Number 8403009, Greenbrae

700732

Investigational Site Number 6423002, Iași

80-382

Investigational Site Number 6163005, Gdansk

81-537

Investigational Site Number 6163006, Gdynia

40-040

Investigational Site Number 6163003, Katowice

01-192

Investigational Site Number 6163001, Warsaw

50-381

Investigational Site Number 6163004, Wroclaw

Unknown

Investigational Site Number 6423004, Bucharest

831 06

Investigational Site Number 7033006, Bratislava

851 01

Investigational Site Number 7033001, Bratislava

Investigational Site Number 7033002, Bratislava

901 01

Investigational Site Number 7033004, Malacky

943 01

Investigational Site Number 7033003, Štúrovo

911 01

Investigational Site Number 7033007, Trenčín

06591

Investigational Site Number 4103007, Seoul

B15 2SQ

Investigational Site Number 8263012, Birmingham

CF15 9SS

Investigational Site Number 8263009, Cardiff

G20 0SP

Investigational Site Number 8263007, Glasgow

NE46 1QJ

Investigational Site Number 8263008, Hexham

IV2 3JH

Investigational Site Number 8263003, Inverness

L22 0LG

Investigational Site Number 8263014, Liverpool

M15 6SE

Investigational Site Number 8263011, Manchester

RG2 0TG

Investigational Site Number 8263010, Reading

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY