Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

782

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

November 30, 2016

Study Completion Date

June 23, 2017

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

Sotagliflozin

High dose Sotagliflozin, once daily, before the first meal of the day

DRUG

Sotagliflozin

Low dose Sotagliflozin,once daily, before the first meal of the day

DRUG

Placebo

Placebo, once daily, before the first meal of the day

Trial Locations (96)

1010

Lexicon Investigational Site, Vienna

1027

Lexicon Investigational Site, Budapest

1030

Lexicon Investigational Site, Vienna

1042

Lexicon Investigational Site, Budapest

1090

Lexicon Investigational Site, Brussels

1097

Lexicon Investigational Site, Budapest

1106

Lexicon Investigational Site, Budapest

1130

Lexicon Investigational Site, Vienna

1134

Lexicon Investigational Site, Budapest

1160

Lexicon Investigational Site, Vienna

1750

Lexicon Investigational Site, Sofia

2018

Lexicon Investigational Site, Antwerp

2650

Lexicon Investigational Site, Edegem

3000

Lexicon Investigational Site, Leuven

3318

Lexicon Investigational Site, Dordrecht

4002

Lexicon Investigational Site, Plovdiv

4021

Lexicon Investigational Site, Linz

4700

Lexicon Investigational Site, Smolyan

5500

Lexicon Investigational Site, Lovech

5700

Lexicon Investigational Site, Gyula

6800

Lexicon Investigational Site, Hódmezővásárhely

7002

Lexicon Investigational Site, Rousse

8900

Lexicon Investigational Site, Zalaegerszeg

9000

Lexicon Investigational Site, Varna

9007

Lexicon Investigational Site, Sankt Gallen

9100

Lexicon Investigational Site, Sint-Niklaas

18012

Lexicon Investigational Site, Granada

20132

Lexicon Investigational Site, Milan

21073

Lexicon Investigational Site, Hamburg

21079

Lexicon Investigational Site, Dijon

22607

Lexicon Investigational Site, Hamburg

29006

Lexicon Investigational Site, Málaga

30029

Lexicon Investigational Site, Nîmes

30173

Lexicon Investigational Site, Hanover

31096

Lexicon Investigational Site, Haifa

34500

Lexicon Investigational Site, Béziers

40210

Lexicon Investigational Site, Düsseldorf

41003

Lexicon Investigational Site, Seville

41009

Lexicon Investigational Site, Seville

41010

Lexicon Investigational Site, Seville

41014

Lexicon Investigational Site, Seville

44000

Lexicon Investigational Site, Nantes

44093

Lexicon Investigational Site, Nantes

46014

Lexicon Investigational Site, Valencia

48145

Lexicon Investigational Site, Münster

49202

Lexicon Investigational Site, Petah Tikva

52621

Lexicon Investigational Site, Tel Litwinsky

55116

Lexicon Investigational Site, Mainz

56124

Lexicon Investigational Site, Pisa

56564

Lexicon Investigational Site, Neuwied

58100

Lexicon Investigational Site, Holon

61480

Lexicon Investigational Site, Tel Aviv

70300

Lexicon Investigational Site, Ẕerifin

90127

Lexicon Investigational Site, Palermo

91120

Lexicon Investigational Site, Jerusalem

95123

Lexicon Investigational Site, Catania

120203

Lexicon Investigational Site, Buzău

410159

Lexicon Investigational Site, Oradea

540142

Lexicon Investigational Site, Târgu Mureş

550371

Lexicon Investigational Site, Sibiu

600238

Lexicon Investigational Site, Bacau

800098

Lexicon Investigational Site, Galati

06126

Lexicon Investigational Site, Perugia

00128

Lexicon Investigational Site, Roma

LT-55201

Lexicon Investigational Site, Jonava

LT-49449

Lexicon Investigational Site, Kaunas

LT-50161

Lexicon Investigational Site, Kaunas

40-060

Lexicon Investigational Site, Katowice

30-015

Lexicon Investigational Site, Krakow

90-242

Lexicon Investigational Site, Lodz

20-538

Lexicon Investigational Site, Lublin

61-655

Lexicon Investigational Site, Poznan

70-506

Lexicon Investigational Site, Szczecin

01-518

Lexicon Investigational Site, Warsaw

02-507

Lexicon Investigational Site, Warsaw

04-736

Lexicon Investigational Site, Warsaw

010507

Lexicon Investigational Site, Bucharest

013764

Lexicon Investigational Site, Bucharest

821 02

Lexicon Investigational Site, Bratislava

851 01

Lexicon Investigational Site, Bratislava

040 01

Lexicon Investigational Site, Košice

940 01

Lexicon Investigational Site, Nové Zámky

943 01

Lexicon Investigational Site, Štúrovo

038 61

Lexicon Investigational Site, Vrútky

08035

Lexicon Investigational Site, Barcelona

08036

Lexicon Investigational Site, Barcelona

871 82

Lexicon Investigational Site, Härnösand

291 85

Lexicon Investigational Site, Kristianstad

112 21

Lexicon Investigational Site, Stockholm

B15 2TH

Lexicon Investigational Site, Birmingham

BB2 3HH

Lexicon Investigational Site, Blackburn

BS10 5NB

Lexicon Investigational Site, Bristol

G4 0SF

Lexicon Investigational Site, Glasgow

LS2 9JT

Lexicon Investigational Site, Leeds

LE5 4PW

Lexicon Investigational Site, Leicester

S5 7AU

Lexicon Investigational Site, Sheffield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY