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

793

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

September 30, 2016

Study Completion Date

February 28, 2017

Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG

Placebo

Placebo once daily, before first meal of the day.

DRUG

Sotagliflozin

Sotagliflozin once daily, before first meal of the day.

Trial Locations (75)

10029

Lexicon Investigational Site, New York

12206

Lexicon Investigational Site, Albany

21204

Lexicon Investigational Site, Baltimore

23321

Lexicon Investigational Site, Chesapeake

27517

Lexicon Investigational Site, Chapel Hill

28557

Lexicon Investigational Site, Morehead City

28803

Lexicon Investigational Site, Asheville

29651

Lexicon Investigational Site, Greer

30046

Lexicon Investigational Site, Lawrenceville

30076

Lexicon Investigational Site, Roswell

30318

Lexicon Investigational Site, Atlanta

32003

Lexicon Investigational Site, Fleming Island

32174

Lexicon Investigational Site, Ormond Beach

32204

Lexicon Investigational Site, Jacksonville

32216

Lexicon Investigational Site, Jacksonville

33401

Lexicon Investigational Site, West Palm Beach

34652

Lexicon Investigational Site, New Port Richey

35294

Lexicon Investigational Site, Birmingham

37404

Lexicon Investigational Site, Chattanooga

37411

Lexicon Investigational Site, Chattanooga

38119

Lexicon Investigational Site, Memphis

40503

Lexicon Investigational Site, Lexington

43201

Lexicon Investigational Site, Columbus

46214

Lexicon Investigational Site, Detroit

57701

Lexicon Investigational Site, Rapid City

60012

Lexicon Investigational Site, Crystal Lake

60123

Lexicon Investigational Site, Elgin

62711

Lexicon Investigational Site, Springfield

63017

Lexicon Investigational Site, Chesterfield

63110

Lexicon Investigational Site, St Louis

66606

Lexicon Investigational Site, Topeka

68131

Lexicon Investigational Site, Omaha

70045

Lexicon Investigational Site, Aurora

72205

Lexicon Investigational Site, Little Rock

73112

Lexicon Investigational Site, Oklahoma City

75230

Lexicon Investigational Site, Dallas

75231

Lexicon Investigational Site, Dallas

75246

Lexicon Investigational Site, Dallas

77079

Lexicon Investigational Site, Houston

77095

Lexicon Investigational Site, Houston

78154

Lexicon Investigational Site, Schertz

78258

Lexicon Investigational Site, San Antonio

78749

Lexicon Investigational Site, Austin

80501

Lexicon Investigational Site, Longmont

89052

Lexicon Investigational Site, Henderson

89148

Lexicon Investigational Site, Las Vegas

91356

Lexicon Investigational Site, Tarzana

92025

Lexicon Investigational Site, Escondido

92037

Lexicon Investigational Site, La Jolla

92262

Lexicon Investigational Site, Palm Springs

92648

Lexicon Investigational Site, Huntington Beach

92780

Lexicon Investigational Site, Tustin

92868

Lexicon Investigational Site, Orange

94401

Lexicon Investigational Site, San Mateo

94598

Lexicon Investigational Site, Walnut Creek

94904

Lexicon Investigational Site, Greenbrae

96814

Lexicon Investigational Site, Honolulu

97239

Lexicon Investigational Site, Portland

98057

Lexicon Investigational Site, Renton

98105

Lexicon Investigational Site, Seattle

90057-3550

Lexicon Investigational Site, Los Angeles

04401

Lexicon Investigational Site, Bangor

02215

Lexicon Investigational Site, Boston

T2H 2G4

Lexicon Investigational Site, Calgary

V5Z 1M9

Lexicon Investigational Site, Vancouver

R3C 0N2

Lexicon Investigational Site, Winnipeg

B3H 1V7

Lexicon Investigational Site, Halifax

L4M 7G1

Lexicon Investigational Site, Barrie

L8N 3Z5

Lexicon Investigational Site, Hamilton

N6A 4V2

Lexicon Investigational Site, London

K1H 7W9

Lexicon Investigational Site, Ottawa

L4J 8L7

Lexicon Investigational Site, Thornhill

M4G 3E8

Lexicon Investigational Site, Toronto

H2W 1R7

Lexicon Investigational Site, Montreal

H4T 1Z9

Lexicon Investigational Site, Saint-Laurent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY