A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

PHASE3CompletedINTERVENTIONAL
Enrollment

277

Participants

Timeline

Start Date

August 16, 2017

Primary Completion Date

May 16, 2019

Study Completion Date

December 11, 2019

Conditions
Type 2 Diabetes MellitusChronic Kidney Disease Stage 4
Interventions
DRUG

Placebo

Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.

DRUG

Sotagliflozin

Sotagliflozin 200 mg, tablet, orally, once daily.

Trial Locations (106)

2188

Investigational Site Number 7105001, Johannesburg

3037

Investigational Site Number 8045001, Kyiv

4032

Investigational Site Number 3485007, Debrecen

4540

Investigational Site Number 6435004, Chelyabinsk

6500

Investigational Site Number 3485005, Baja

7505

Investigational Site Number 7105003, Cape Town

7570

Investigational Site Number 7105004, Cape Town

7624

Investigational Site Number 3485004, Pécs

10455

Investigational Site Number 8405014, The Bronx

11413

Investigational Site Number 8405027, Laurelton

12206

Investigational Site Number 8405035, Albany

13100

Investigational Site Number 3765006, Safed

15405

Investigational Site Number 7245003, Ferrol

18012

Investigational Site Number 7245009, Granada

20132

Investigational Site Number 3805005, Milan

22601

Investigational Site Number 8405040, Winchester

27100

Investigational Site Number 3805001, Pavia

27103

Investigational Site Number 8405038, Winston-Salem

28041

Investigational Site Number 7245006, Madrid

29010

Investigational Site Number 7245004, Málaga

30046

Investigational Site Number 8405039, Lawrenceville

30625

Investigational Site Number 2765003, Hanover

31096

Investigational Site Number 3765001, Haifa

41009

Investigational Site Number 7245001, Seville

44130

Investigational Site Number 4845007, Guadalajara Jalisco

44210

Investigational Site Number 4845001, Guadalajara

44281

Investigational Site Number 3765007, Kfar Saba

44600

Investigational Site Number 4845004, Guadalajara

48145

Investigational Site Number 2765004, Münster

50009

Investigational Site Number 7245002, Zaragoza

52621

Investigational Site Number 3765005, Ramat Gan

58022

Investigational Site Number 8045004, Chernivtsi

58260

Investigational Site Number 4845003, Morelia

60596

Investigational Site Number 2765001, Frankfurt am Main

61480

Investigational Site Number 3765003, Tel Aviv

64460

Investigational Site Number 4845006, Monterrey, N.L

69600

Investigational Site Number 8045002, Zaporizhzhia

70601

Investigational Site Number 8405019, Lake Charles

72205

Investigational Site Number 8405007, Little Rock

75208

Investigational Site Number 8405036, Dallas

76000

Investigational Site Number 4845002, Querétaro

76054

Investigational Site Number 8405047, Hurst

77058

Investigational Site Number 8405020, Houston

77702

Investigational Site Number 8405004, Beaumont

78215

Investigational Site Number 8405031, San Antonio

78278

Investigational Site Number 3765002, Ashkelon

80020

Investigational Site Number 1705004, Barranquilla

80138

Investigational Site Number 3805002, Napoli

91020

Investigational Site Number 4845005, Xalapa

91324

Investigational Site Number 8405013, Northridge

91773

Investigational Site Number 8405018, San Dimas

91910

Investigational Site Number 8405015, Chula Vista

92037

Investigational Site Number 8405032, La Jolla

95123

Investigational Site Number 3805003, Catania

97130

Investigational Site Number 4845008, Merida, Yucatan

110221

Investigational Site Number 1705005, Bogotá

170004

Investigational Site Number 1705002, Manizales

194358

Investigational Site Number 6435001, Saint Petersburg

250252

Investigational Site Number 1705001, Zipaquirá

331057

Investigational Site Number 6425007, Hunedoara

350032

Investigational Site Number 6435003, Krasnodar

540142

Investigational Site Number 6425001, Târgu Mureş

600238

Investigational Site Number 6425005, Bacau

630091

Investigational Site Number 6435006, Novosibirsk

650002

Investigational Site Number 6435005, Kemerovo

700503

Investigational Site Number 6425004, Lasi

7642001

Investigational Site Number 3765004, Rehovot

35976-2206

Investigational Site Number 8405033, Guntersville

85018-2701

Investigational Site Number 8405005, Phoenix

92860-3611

Investigational Site Number 8405003, Norco

33761-2022

Investigational Site Number 8405021, Clearwater

32720-0834

Investigational Site Number 8405001, DeLand

33155-4630

Investigational Site Number 8405043, Miami

34761-4547

Investigational Site Number 8405006, Ocoee

32174-8187

Investigational Site Number 8405025, Ormond Beach

60005-4197

Investigational Site Number 8405041, Arlington Heights

47172-8932

Investigational Site Number 8405030, Sellersburg

48532-3447

Investigational Site Number 8405034, Flint

68701-2669

Investigational Site Number 8405012, Norfolk

28562-5200

Investigational Site Number 8405037, New Bern

45419-4336

Investigational Site Number 8405009, Dayton

77099-4307

Investigational Site Number 8405026, Houston

78249-2782

Investigational Site Number 8405016, San Antonio

84041-1200

Investigational Site Number 8405008, Layton

C1425DES

Investigational Site Number 0325001, Buenos Aires

B1824KAJ

Investigational Site Number 0325003, Launs Este

B7600

Investigational Site Number 0325004, Mar del Plata

66073-005

Investigational Site Number 0765003, Belém

60170-195

Investigational Site Number 0765001, Fortaleza

22271-100

Investigational Site Number 0765004, Rio de Janeiro

01244-030

Investigational Site Number 0765002, São Paulo

00181

Investigational Site Number 3805006, Napoli

00168

Investigational Site Number 3805004, Roma

31-209

Investigational Site Number 6165003, Krakow

92-213

Investigational Site Number 6165002, Lodz

32-600

Investigational Site Number 6165004, Oświęcim

24-100

Investigational Site Number 6165005, Puławy

35-055

Investigational Site Number 6165001, Rzeszów

010825

Investigational Site Number 6425002, Bucharest

020475

Investigational Site Number 6425003, Bucharest

0002

Investigational Site Number 7105002, Pretoria

08035

Investigational Site Number 7245005, Barcelona

08036

Investigational Site Number 7245007, Barcelona

02002

Investigational Site Number 8045006, Kiev

02091

Investigational Site Number 8045007, Kyiv

04050

Investigational Site Number 8045003, Kyiv

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY