Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

PHASE3CompletedINTERVENTIONAL
Enrollment

787

Participants

Timeline

Start Date

August 16, 2017

Primary Completion Date

March 25, 2019

Study Completion Date

October 25, 2019

Conditions
Type 2 Diabetes MellitusChronic Kidney Disease Stage 3
Interventions
DRUG

Placebo

"Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily.~Route of administration: Oral"

DRUG

Sotagliflozin

"Sotagliflozin 200 mg, tablet, orally once daily.~Route of administration: Oral"

Trial Locations (170)

1033

Investigational Site Number 3484007, Budapest

1205

Investigational Site Number 0324005, Ciudad Autónoma Buenos Aires

1685

Investigational Site Number 7104001, Johannesburg

1900

Investigational Site Number 0324009, La Plata

2188

Investigational Site Number 7104010, Johannesburg

2198

Investigational Site Number 7104005, Johannesburg

3500

Investigational Site Number 6434002, Krasnodar

4025

Investigational Site Number 3484011, Debrecen

4032

Investigational Site Number 3484005, Debrecen

4400

Investigational Site Number 3484013, Nyregyhza

4405

Investigational Site Number 3484010, Nyíregyháza

5000

Investigational Site Number 0324008, Córdoba

5700

Investigational Site Number 3484001, Gyula

6500

Investigational Site Number 3484008, Baja

Investigational Site Number 3484012, Baja

7531

Investigational Site Number 7104008, Cape Town

7570

Investigational Site Number 7104002, Cape Town

7623

Investigational Site Number 3484004, Pécs

8230

Investigational Site Number 3484002, Balatonfüred

10455

Investigational Site Number 8404009, The Bronx

13100

Investigational Site Number 3764008, Safed

18012

Investigational Site Number 7244007, Granada

20122

Investigational Site Number 3804005, Milan

20132

Investigational Site Number 3804004, Milan

21073

Investigational Site Number 2764002, Hamburg

22100

Investigational Site Number 3764003, Nahariya

28041

Investigational Site Number 7244003, Madrid

29464

Investigational Site Number 8404021, Mt. Pleasant

29621

Investigational Site Number 8404031, Anderson

31096

Investigational Site Number 3764007, Haifa

31217

Investigational Site Number 4844009, Chihuahua Chihuahua

31406

Investigational Site Number 8404016, Savannah

32806

Investigational Site Number 8404064, Orlando

33761

Investigational Site Number 8404019, Clearwater

34080

Investigational Site Number 4844008, Durango, Durango

35205

Investigational Site Number 8404018, Birmingham

37404

Investigational Site Number 8404056, Chattanooga

41071

Investigational Site Number 7244001, Seville

44210

Investigational Site Number 4844001, Guadalajara

44281

Investigational Site Number 3764009, Kfar Saba

Investigational Site Number 3764011, Kfar Saba

44600

Investigational Site Number 4844003, Guadalajara

46014

Investigational Site Number 7244002, Valencia

48145

Investigational Site Number 2764003, Münster

49005

Investigational Site Number 8044004, Dnipropetrovsk

49100

Investigational Site Number 3764004, Petah Tikva

50009

Investigational Site Number 7244009, Zaragoza

50021

Investigational Site Number 1704002, Medellin / Antioquia

52621

Investigational Site Number 3764006, Ramat Gan

53100

Investigational Site Number 3804006, Siena

53144

Investigational Site Number 8404047, Kenosha

60596

Investigational Site Number 2764001, Frankfurt am Main

61106

Investigational Site Number 8044007, Kharkiv

61166

Investigational Site Number 8044010, Kharkiv

61480

Investigational Site Number 3764002, Tel Aviv

64460

Investigational Site Number 4844005, Monterrey

68701

Investigational Site Number 8404014, Norfolk

69600

Investigational Site Number 8044002, Zaporizhia

70300

Investigational Site Number 3764013, Ẕerifin

70601

Investigational Site Number 8404036, Lake Charles

72205

Investigational Site Number 8404007, Little Rock

75208

Investigational Site Number 8404035, Dallas

76054

Investigational Site Number 8404012, Hurst

76100

Investigational Site Number 3764005, Rehovot

77058

Investigational Site Number 8404039, Houston

77099

Investigational Site Number 8404055, Houston

77702

Investigational Site Number 8404005, Beaumont

78212

Investigational Site Number 8404059, San Antonio

78504

Investigational Site Number 8404053, McAllen

78681

Investigational Site Number 8404057, Round Rock

78731

Investigational Site Number 8404050, Austin

78749

Investigational Site Number 8404060, Austin

79010

Investigational Site Number 8044005, Lviv

80020

Investigational Site Number 1704007, Barranquilla

80131

Investigational Site Number 3804008, Naples

80138

Investigational Site Number 3804002, Napoli

84101

Investigational Site Number 3764010, Beersheba

90057

Investigational Site Number 8404011, Los Angeles

91020

Investigational Site Number 4844004, Xalapa

91324

Investigational Site Number 8404025, Northridge

91713

Investigational Site Number 8404038, San Dimas

91910

Investigational Site Number 8404023, Chula Vista

92860

Investigational Site Number 8404003, Norco

95123

Investigational Site Number 3804007, Catania

95670

Investigational Site Number 8404044, Gold River

97130

Investigational Site Number 4844006, Merida, Yucatan

98057

Investigational Site Number 8404042, Renton

98105

Investigational Site Number 8404041, Seattle

110221

Investigational Site Number 1704004, Bogotá

110911

Investigational Site Number 1704009, Bogotá

150003

Investigational Site Number 6434006, Yaroslavl

170004

Investigational Site Number 1704001, Manizales

194358

Investigational Site Number 6434001, Saint Petersburg

250252

Investigational Site Number 1704005, Zipaquirá

331057

Investigational Site Number 6424006, Hunedoara

410159

Investigational Site Number 6424011, Oradea

454047

Investigational Site Number 6434003, Chelyabinsk

540142

Investigational Site Number 6424003, Târgu Mureş

600154

Investigational Site Number 6424002, Bacau

600238

Investigational Site Number 6424001, Bacau

630091

Investigational Site Number 6434004, Novosibirsk

650002

Investigational Site Number 6434005, Kemerovo

730006

Investigational Site Number 1704006, Ibagué

7830604

Investigational Site Number 3764001, Ashkelon

35976-2206

Investigational Site Number 8404045, Guntersville

85018-2701

Investigational Site Number 8404004, Phoenix

85050-7500

Investigational Site Number 8404022, Phoenix

32720-0834

Investigational Site Number 8404001, DeLand

34761-4547

Investigational Site Number 8404006, Ocoee

32174-8187

Investigational Site Number 8404043, Ormond Beach

33157-5503

Investigational Site Number 8404013, Palmetto Bay

60084-2452

Investigational Site Number 8404040, Wauconda

70119-6302

Investigational Site Number 8404020, New Orleans

68046-3136

Investigational Site Number 8404032, Papillion

07601-1963

Investigational Site Number 8404048, Hackensack

00000

Investigational Site Number 8404074, New York

28401-6638

Investigational Site Number 8404051, Wilmington

27103-3914

Investigational Site Number 8404028, Winston-Salem

27103-4027

Investigational Site Number 8404029, Winston-Salem

45419-4336

Investigational Site Number 8404026, Dayton

19446-1002

Investigational Site Number 8404052, Lansdale

78726-4061

Investigational Site Number 8404015, Austin

76550-1820

Investigational Site Number 8404033, Lampasas

78249-2782

Investigational Site Number 8404010, San Antonio

84041-1200

Investigational Site Number 8404008, Layton

C1429BWN

Investigational Site Number 0324001, Buenos Aires

1425DES

Investigational Site Number 0324002, Caba

X5008HHW

Investigational Site Number 0324006, Córdoba

B7600FYK

Investigational Site Number 0324007, Mar del Plata

66073-005

Investigational Site Number 0764001, Belém

30150-240

Investigational Site Number 0764007, Belo Horizonte

80030-480

Investigational Site Number 0764002, Curitiba

80810-040

Investigational Site Number 0764008, Curitiba

22271-100

Investigational Site Number 0764005, Rio de Janeiro

01244-030

Investigational Site Number 0764004, São Paulo

04266-010

Investigational Site Number 0764006, São Paulo

L6S 0C6

Investigational Site Number 1244007, Brampton

L7R 1A4

Investigational Site Number 1244004, Burlington

M9R 4E1

Investigational Site Number 1244005, Etobicoke

H7T 2P5

Investigational Site Number 1244006, Laval

H4A 2C6

Investigational Site Number 1244009, Montreal

K2J 0V2

Investigational Site Number 1244010, Ottawa

L4J 8L7

Investigational Site Number 1244003, Thornhill

M4C 5T2

Investigational Site Number 1244002, Toronto

M4G 3E8

Investigational Site Number 1244008, Toronto

V5Y 3W2

Investigational Site Number 1244001, Vancouver

080001

Investigational Site Number 1704008, Barranquilla

00168

Investigational Site Number 3804003, Roma

15-435

Investigational Site Number 6164002, Bialystok

40-081

Investigational Site Number 6164006, Katowice

30-033

Investigational Site Number 6164010, Krakow

30-363

Investigational Site Number 6164009, Krakow

31-209

Investigational Site Number 6164004, Krakow

31-530

Investigational Site Number 6164008, Krakow

92-213

Investigational Site Number 6164011, Lodz

32-600

Investigational Site Number 6164005, Oświęcim

35-055

Investigational Site Number 6164003, Rzeszów

96-100

Investigational Site Number 6164012, Skierniewice

02-507

Investigational Site Number 6164007, Warsaw

010825

Investigational Site Number 6424004, Bucharest

013764

Investigational Site Number 6424009, Bucharest

040172

Investigational Site Number 6424010, Bucharest

0002

Investigational Site Number 7104006, Pretoria

08035

Investigational Site Number 7244011, Barcelona

07010

Investigational Site Number 7244006, Palma de Mallorca

02002

Investigational Site Number 8044008, Kiev

04050

Investigational Site Number 8044003, Kiev

02091

Investigational Site Number 8044009, Kyiv

03037

Investigational Site Number 8044001, Kyiv

03049

Investigational Site Number 8044006, Kyiv

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY