A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

1,405

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

April 30, 2017

Conditions
Type 1 Diabetes Mellitus (T1DM)High Level of Sugar (Glucose) in the Blood
Interventions
DRUG

Sotagliflozin

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

DRUG

Placebo

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

Trial Locations (135)

1027

Lexicon Investigational Site, Budapest

1033

Lexicon Investigational Site, Budapest

1051

Lexicon Investigational Site, Epsom

1055

Lexicon Investigational Site, Middelburg

1088

Lexicon Investigational Site, Budapest

1213

Lexicon Investigational Site, Budapest

1431

Lexicon Investigational Site, Sofia

1640

Lexicon Investigational Site, Otahuhu

1750

Lexicon Investigational Site, Sofia

2065

Lexicon Investigational Site, St Leonards

2198

Lexicon Investigational Site, Johannesburg

2291

Lexicon Investigational Site, Merewether

2450

Lexicon Investigational Site, Coffs Harbour

2500

Lexicon Investigational Site, Wollongong

Lexicon Investigational Site, Esztergom

3050

Lexicon Investigational Site, Parkville

3065

Lexicon Investigational Site, Fitzroy

3128

Lexicon Investigational Site, Box Hill

3300

Lexicon Investigational Site, Eger

3980

Lexicon Investigational Site, Sátoraljaújhely

4002

Lexicon Investigational Site, Plovdiv

4029

Lexicon Investigational Site, Herston

4700

Lexicon Investigational Site, Smolyan

5035

Lexicon Investigational Site, Keswick

6021

Lexicon Investigational Site, Newtown

6045

Lexicon Investigational Site, Port Elizabeth

7003

Lexicon Investigational Site, Rousse

7130

Lexicon Investigational Site, Cape Town

7460

Lexicon Investigational Site, Goodwood

7580

Lexicon Investigational Site, Cape Town

8001

Lexicon Investigational Site, Christchurch

8011

Lexicon Investigational Site, Christchurch

9000

Lexicon Investigational Site, Ghent

Lexicon Investigational Site, Varna

9016

Lexicon Investigational Site, Dunedin

9023

Lexicon Investigational Site, Győr

9100

Lexicon Investigational Site, Sint-Niklaas

9300

Lexicon Investigational Site, Aalst

Lexicon Investigational Site, Bloemfontein

10467

Lexicon Investigational Site, The Bronx

12206

Lexicon Investigational Site, Albany

20132

Lexicon Investigational Site, Milan

20852

Lexicon Investigational Site, Rockville

27517

Lexicon Investigational Site, Chapel Hill

27834

Lexicon Investigational Site, Greenville

28557

Lexicon Investigational Site, Morehead City

28803

Lexicon Investigational Site, Asheville

29006

Lexicon Investigational Site, Málaga

30076

Lexicon Investigational Site, Roswell

30318

Lexicon Investigational Site, Atlanta

31210

Lexicon Investigational Site, Macon

32804

Lexicon Investigational Site, Orlando

33401

Lexicon Investigational Site, West Palm Beach

35614

Lexicon Investigational Site, Aßlar

40138

Lexicon Investigational Site, Bologna

41009

Lexicon Investigational Site, Seville

41071

Lexicon Investigational Site, Seville

48153

Lexicon Investigational Site, Münster

48302

Lexicon Investigational Site, Bloomfield Hills

55116

Lexicon Investigational Site, Mainz

56261

Lexicon Investigational Site, Tel Litwinsky

57104

Lexicon Investigational Site, Sioux Falls

58100

Lexicon Investigational Site, Holon

58201

Lexicon Investigational Site, Grand Forks

63739

Lexicon Investigational Site, Aschaffenburg

68114

Lexicon Investigational Site, Omaha

69495

Lexicon Investigational Site, Pierre-Bénite

70112

Lexicon Investigational Site, New Orleans

76100

Lexicon Investigational Site, Rehovot

78229

Lexicon Investigational Site, San Antonio

78231

Lexicon Investigational Site, Shavano Park

78731

Lexicon Investigational Site, Austin

80045

Lexicon Investigational Site, Aurora

84107

Lexicon Investigational Site, Salt Lake City

85101

Lexicon Investigational Site, Bratislava

89148

Lexicon Investigational Site, Las Vegas

91106

Lexicon Investigational Site, Corbeil-Essonnes

92025

Lexicon Investigational Site, Escondido

92037

Lexicon Investigational Site, La Jolla

92237

Lexicon Investigational Site, Sulzbach

93003

Lexicon Investigational Site, Ventura

94401

Lexicon Investigational Site, San Marcos

94520

Lexicon Investigational Site, Concord

94598

Lexicon Investigational Site, Walnut Creek

95122

Lexicon Investigational Site, Catania

95123

Lexicon Investigational Site, Catania

97701

Lexicon Investigational Site, Bend

98105

Lexicon Investigational Site, Seattle

110221

Lexicon Investigational Site, Cundinamarca

111211

Lexicon Investigational Site, Cundinamarca

111311

Lexicon Investigational Site, Cundinamarca

4920235

Lexicon Investigational Site, Petach-Tikvah

4941492

Lexicon Investigational Site, Petah Tikva

06511

Lexicon Investigational Site, New Haven

02215

Lexicon Investigational Site, Boston

X5006IKK

Lexicon Investigational Site, Córdoba

B7600FZN

Lexicon Investigational Site, Buenos Aires

C1180AAX

Lexicon Investigational Site, Buenos Aires

V5Y 3W2

Lexicon Investigational Site, Vancouver

B3H 2Y9

Lexicon Investigational Site, Halifax

L4M 7G1

Lexicon Investigational Site, Barrie

N6A 4V2

Lexicon Investigational Site, London

L6B 0P9

Lexicon Investigational Site, Markham

L6M 1M1

Lexicon Investigational Site, Oakville

L4J 8L7

Lexicon Investigational Site, Thornhill

M4G 3E8

Lexicon Investigational Site, Toronto

H4T 1Z9

Lexicon Investigational Site, Saint-Laurent

J1G 5K2

Lexicon Investigational Site, Sherbrooke

080020

Lexicon Investigational Site, Atlántico

794 01

Lexicon Investigational Site, Krnov

779 00

Lexicon Investigational Site, Olomouc

702 00

Lexicon Investigational Site, Ostrava

104 00

Lexicon Investigational Site, Prague

149 00

Lexicon Investigational Site, Prague

150 98

Lexicon Investigational Site, Prague

04100

Lexicon Investigational Site, Latina

00128

Lexicon Investigational Site, Rome

0620

Lexicon Investigational Site, Takapuna

81-338

Lexicon Investigational Site, Gdynia

40-060

Lexicon Investigational Site, Katowice

40-954

Lexicon Investigational Site, Katowice

20-538

Lexicon Investigational Site, Lublin

01-868

Lexicon Investigational Site, Warsaw

02-507

Lexicon Investigational Site, Warsaw

04-736

Lexicon Investigational Site, Warsaw

085 01

Lexicon Investigational Site, Bardejov

851 01

Lexicon Investigational Site, Bratislava

934 01

Lexicon Investigational Site, Levice

08035

Lexicon Investigational Site, Barcelona

08036

Lexicon Investigational Site, Barcelona

DD1 9SY

Lexicon Investigational Site, Dundee

BB2 3HH

Lexicon Investigational Site, Blackburn

GU2 7XX

Lexicon Investigational Site, Guildford

LE5 4PW

Lexicon Investigational Site, Leicester

NN1 5BD

Lexicon Investigational Site, Northampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY