Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

PHASE3TerminatedINTERVENTIONAL
Enrollment

376

Participants

Timeline

Start Date

February 19, 2018

Primary Completion Date

May 22, 2019

Study Completion Date

May 30, 2020

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sotagliflozin

Pharmaceutical form: Tablet; Route of administration: Oral

DRUG

Placebo

Pharmaceutical form: Tablet; Route of administration: Oral

Trial Locations (53)

100

Investigational Site Number 1589004, Taipei

220

Investigational Site Number 1589008, New Taipei City

402

Investigational Site Number 1589006, Taichung

500

Investigational Site Number 1589005, Changhua

710

Investigational Site Number 1589001, Tainan City

1309

Investigational Site Number 5549004, Auckland

1830

Investigational Site Number 4109001, Seoul

2291

Investigational Site Number 0369002, Merewether

3010

Investigational Site Number 5549001, Rotorua

3050

Investigational Site Number 0369004, Parkville

6021

Investigational Site Number 5549002, Wellington

6160

Investigational Site Number 0369003, Fremantle

8011

Investigational Site Number 5549003, Christchurch

11217

Investigational Site Number 1589003, Taipei

11923

Investigational Site Number 4109005, Guri-Si, Gyeonggi-Do

13620

Investigational Site Number 4109003, Gyeonggi-do

20129

Investigational Site Number 4849001, Aguascalientes

20230

Investigational Site Number 4849006, Aguascalientes, Aguascalientes

27517

Investigational Site Number 8409002, Chapel Hill

31904

Investigational Site Number 8409012, Columbus

35233

Investigational Site Number 4109006, Daejeon

37404

Investigational Site Number 8409004, Chattanooga

43303

Investigational Site Number 1589007, Taichung

44130

Investigational Site Number 4849002, Guadalajara Jalisco

62250

Investigational Site Number 4849003, Cuernavaca

64460

Investigational Site Number 4849004, Monterrey

75230

Investigational Site Number 8409003, Dallas

77450

Investigational Site Number 8409007, Katy

78749

Investigational Site Number 8409013, Austin

87106

Investigational Site Number 8409015, Albuquerque

91020

Investigational Site Number 4849005, Xalapa

92025

Investigational Site Number 8409009, Escondido

94598

Investigational Site Number 8409005, Walnut Creek

94904

Investigational Site Number 8409010, Greenbrae

150003

Investigational Site Number 6439006, Yaroslavl

194358

Investigational Site Number 6439001, Saint Petersburg

195213

Investigational Site Number 6439002, Saint Petersburg

196601

Investigational Site Number 6439003, Saint Petersburg

630091

Investigational Site Number 6439005, Novosibirsk

650002

Investigational Site Number 6439007, Kemerovo

47714-8011

Investigational Site Number 8409011, Evansville

67205-1138

Investigational Site Number 8409014, Wichita

28401-6638

Investigational Site Number 8409001, Wilmington

45419-4336

Investigational Site Number 8409008, Dayton

L6S 0C6

Investigational Site Number 1249003, Brampton

M9R 4E1

Investigational Site Number 1249008, Etobicoke

H9R 4S3

Investigational Site Number 1249005, Pointe-Claire

L4J 1W3

Investigational Site Number 1249006, Thornhill

L4J 8L7

Investigational Site Number 1249004, Thornhill

V5Y 3W2

Investigational Site Number 1249007, Vancouver

G6P 6P6

Investigational Site Number 1249002, Victoriaville

03722

Investigational Site Number 4109004, Seoul

Unknown

Investigational Site Number 1589002, Tainan City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY