Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

770

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

May 16, 2019

Study Completion Date

May 16, 2019

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Sotagliflozin

Sotagliflozin 400 mg was administered as two tablets, once daily before the first meal of the day.

DRUG

Empagliflozin

Empagliflozin 25 mg capsule was administered, once daily before the first meal of the day.

DRUG

Placebo

Placebo was administered as two tablets (identical to sotagliflozin in appearance), once daily before the first meal of the day.

DRUG

Placebo

Placebo was administered as one capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day.

Trial Locations (160)

161

Investigational Site Number 3808007, Roma

1606

Investigational Site Number 1008008, Sofia

1632

Investigational Site Number 1008012, Sofia

1701

Investigational Site Number 7038004, Považská Bystrica

3301

Investigational Site Number 4288004, Kuldīga

4000

Investigational Site Number 1008006, Plovdiv

Investigational Site Number 4288008, Limbaži

4002

Investigational Site Number 1008001, Plovdiv

4014

Investigational Site Number 7038001, Košice

4700

Investigational Site Number 1008002, Smolyan

5001

Investigational Site Number 4288003, Ogre

5300

Investigational Site Number 1008011, Gabrovo

6000

Investigational Site Number 1008003, Stara Zagora

Investigational Site Number 1008010, Stara Zagora

7002

Investigational Site Number 1008005, Rousse

7003

Investigational Site Number 1008007, Rousse

8035

Investigational Site Number 7248006, Barcelona

8210

Investigational Site Number 7038009, Bratislava

9000

Investigational Site Number 1008004, Varna

14011

Investigational Site Number 7248002, Córdoba

14224

Investigational Site Number 8408027, West Seneca

15706

Investigational Site Number 7248009, Santiago de Compostela

18100

Investigational Site Number 2038005, Prague

20110

Investigational Site Number 8408004, Manassas

20122

Investigational Site Number 3808004, Milan

20132

Investigational Site Number 3808005, Milan

20852

Investigational Site Number 8408002, Rockville

22015

Investigational Site Number 8408006, Burke

27100

Investigational Site Number 3808009, Pavia

27408

Investigational Site Number 8408012, Greensboro

28314

Investigational Site Number 8408037, Fayetteville

29006

Investigational Site Number 7248005, Malaga Malaga

31200

Investigational Site Number 4848002, Chihuahua City

31210

Investigational Site Number 8408074, Macon

31406

Investigational Site Number 8408079, Savannah

31904

Investigational Site Number 8408061, Columbus

32810

Investigational Site Number 8408005, Orlando

32825

Investigational Site Number 8408040, Orlando

33952

Investigational Site Number 8408064, Port Charlotte

34080

Investigational Site Number 4848007, Durango, Durango

34761

Investigational Site Number 8408049, Ocoee

35205

Investigational Site Number 8408035, Birmingham

35660

Investigational Site Number 8408028, Sheffield

37760

Investigational Site Number 8408018, Jefferson City

37938

Investigational Site Number 8408038, Knoxville

38700

Investigational Site Number 2508007, La Tronche

41010

Investigational Site Number 7248004, Seville

41013

Investigational Site Number 7248008, Seville

41071

Investigational Site Number 7248001, Seville

44093

Investigational Site Number 2508002, Nantes

46014

Investigational Site Number 7248003, Valencia

48532

Investigational Site Number 8408008, Flint

50009

Investigational Site Number 7248007, Zaragoza

53100

Investigational Site Number 3808006, Siena

60124

Investigational Site Number 8408033, Elgin

62250

Investigational Site Number 4848003, Cuernavaca

64020

Investigational Site Number 4848001, Monterrey

64460

Investigational Site Number 4848012, Monterrey

66100

Investigational Site Number 3808002, Chieti

68100

Investigational Site Number 2508003, Mulhouse

70124

Investigational Site Number 8408003, New Orleans

71013

Investigational Site Number 3808011, San Giovanni Rotondo

75018

Investigational Site Number 2508001, Paris

75024

Investigational Site Number 8408042, Plano

75149

Investigational Site Number 8408039, Mesquite

75208

Investigational Site Number 8408056, Dallas

75230

Investigational Site Number 8408082, Dallas

75231

Investigational Site Number 8408052, Dallas

77004

Investigational Site Number 8408001, Houston

Investigational Site Number 8408032, Houston

77040

Investigational Site Number 8408016, Houston

77058

Investigational Site Number 8408017, Houston

77061

Investigational Site Number 8408036, Houston

77099

Investigational Site Number 8408022, Houston

77450

Investigational Site Number 8408029, Katy

78154

Investigational Site Number 8408041, Schertz

78504

Investigational Site Number 8408054, McAllen

80234

Investigational Site Number 8408069, Northglenn

83221

Investigational Site Number 8408051, Blackfoot

84117

Investigational Site Number 8408026, Holladay

85925

Investigational Site Number 2508006, La Roche-sur-Yon

90716

Investigational Site Number 8408047, Hawaiian Gardens

91106

Investigational Site Number 2508005, Corbeil-Essonnes

91405

Investigational Site Number 8408067, Van Nuys

91978

Investigational Site Number 8408031, Spring Valley

94160

Investigational Site Number 2508004, Saint-Mandé

95122

Investigational Site Number 3808010, Catania

95123

Investigational Site Number 3808003, Catania

140091

Investigational Site Number 6438006, Dzerzhinsky

150002

Investigational Site Number 6438011, Yaroslavl

188643

Investigational Site Number 6438007, Vsevolozhsk

190013

Investigational Site Number 6438013, Saint Petersburg

192012

Investigational Site Number 6438003, Saint Petersburg

194354

Investigational Site Number 6438014, Saint Petersburg

194358

Investigational Site Number 6438002, Saint Petersburg

195213

Investigational Site Number 6438005, Saint Petersburg

196601

Investigational Site Number 6438001, Saint Petersburg

400001

Investigational Site Number 6438015, Volgograd

410054

Investigational Site Number 6438012, Saratov

454047

Investigational Site Number 6438008, Chelyabinsk

630091

Investigational Site Number 6438010, Novosibirsk

650002

Investigational Site Number 6438009, Kemerovo

33183-4825

Investigational Site Number 8408009, Miami

33157-5503

Investigational Site Number 8408019, Palmetto Bay

30461-0845

Investigational Site Number 8408059, Statesboro

02721-3005

Investigational Site Number 8408044, Fall River

27408-7042

Investigational Site Number 8408053, Greensboro

28144-2742

Investigational Site Number 8408013, Salisbury

73104-3252

Investigational Site Number 8408045, Oklahoma City

02888-3360

Investigational Site Number 8408068, Warwick

29707-4514

Investigational Site Number 8408060, Fort Mill

37912-4707

Investigational Site Number 8408010, Knoxville

78520-7512

Investigational Site Number 8408072, Brownsville

78229-3818

Investigational Site Number 8408011, San Antonio

84010-7717

Investigational Site Number 8408007, Bountiful

L6T 0G1

Investigational Site Number 1248001, Brampton

L7M 4Y1

Investigational Site Number 1248007, Burlington

L3Y 5G8

Investigational Site Number 1248003, Newmarket

G1N 4V3

Investigational Site Number 1248010, Québec

J1L 0H8

Investigational Site Number 1248009, Sherbrooke

L4J 1W3

Investigational Site Number 1248002, Thornhill

M3M 3E5

Investigational Site Number 1248004, Toronto

M9W 4L6

Investigational Site Number 1248011, Toronto

V5Y 3W2

Investigational Site Number 1248005, Vancouver

G6P 6P6

Investigational Site Number 1248008, Victoriaville

250 01

Investigational Site Number 2038007, Brandys

736 01

Investigational Site Number 2038003, Havířov

794 01

Investigational Site Number 2038004, Krnov

710 00

Investigational Site Number 2038011, Ostrava

530 02

Investigational Site Number 2038006, Pardubice

363 01

Investigational Site Number 2038010, Pilsen

110 00

Investigational Site Number 2038009, Prague

128 00

Investigational Site Number 2038013, Prague

149 00

Investigational Site Number 2038002, Prague

190 14

Investigational Site Number 2038008, Prague

104 00

Investigational Site Number 2038001, Praha 10 - Uhrineves

00133

Investigational Site Number 3808008, Roma

00168

Investigational Site Number 3808001, Roma

LV -1021

Investigational Site Number 4288007, Riga

LV-1002

Investigational Site Number 4288001, Riga

LV-1011

Investigational Site Number 4288002, Riga

LV-2150

Investigational Site Number 4288006, Sigulda

LV-3200

Investigational Site Number 4288005, Talsi

06700

Investigational Site Number 4848011, Mexico City

07960-6136

Investigational Site Number 4848005, Monterrey

085 01

Investigational Site Number 7038005, Bardejov

984 01

Investigational Site Number 7038006, Lučenec

940 01

Investigational Site Number 7038008, Nové Zámky

048 01

Investigational Site Number 7038002, Rožňava

08301

Investigational Site Number 7038007, Sabinov

038 61

Investigational Site Number 7038003, Vrútky

08923

Investigational Site Number 7248010, Santa Coloma de Gramenet

DL3 6HX

Investigational Site Number 8268008, Darlington

DD1 9SY

Investigational Site Number 8268004, Dundee

EX2 5DW

Investigational Site Number 8268006, Exeter

HU3 2RW

Investigational Site Number 8268001, Hull

PE29 6NT

Investigational Site Number 8268002, Huntingdon

S5 7AU

Investigational Site Number 8268007, Sheffield

SO30 3JB

Investigational Site Number 8268003, Southampton

WV10 0QP

Investigational Site Number 8268005, Wolverhampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Lexicon Pharmaceuticals

INDUSTRY