Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

PHASE3CompletedINTERVENTIONAL
Enrollment

1,014

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Insulin Glargine (HOE901 - U300)

Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).

DRUG

Insulin Glargine (HOE901 - U100)

Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).

DRUG

Background therapy

Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.

Trial Locations (162)

27

Investigational Site Number 604002, Lima

1036

Investigational Site Number 348001, Budapest

1062

Investigational Site Number 348005, Budapest

Investigational Site Number 348007, Budapest

1120

Investigational Site Number 032001, Caba

1180

Investigational Site Number 032006, Capital Federal

1206

Investigational Site Number 032004, Ciudad Autonoma de Buenos Aire

1213

Investigational Site Number 348003, Budapest

1405

Investigational Site Number 032002, Caba

3065

Investigational Site Number 036004, Fitzroy

3128

Investigational Site Number 036002, Box Hill

3220

Investigational Site Number 036001, Geelong

4029

Investigational Site Number 036003, Herston

4031

Investigational Site Number 348009, Debrecen

5700

Investigational Site Number 348002, Gyula

6640

Investigational Site Number 348008, Csongrád

7602

Investigational Site Number 032003, Mar del Plata

8230

Investigational Site Number 348004, Balatonfüred

10001

Investigational Site Number 840018, New York

11540

Investigational Site Number 724003, Sanlúcar de Barrameda

14469

Investigational Site Number 276005, Potsdam

15006

Investigational Site Number 724008, A Coruña

15220

Investigational Site Number 840017, Pittsburgh

15405

Investigational Site Number 724002, Ferrol

16132

Investigational Site Number 380003, Genova

19053

Investigational Site Number 840045, Feasterville

20001

Investigational Site Number 604003, Piura

20122

Investigational Site Number 380002, Milan

20132

Investigational Site Number 380001, Milan

20230

Investigational Site Number 484002, Aguascalientes

26330

Investigational Site Number 840060, Bridgeport

27408

Investigational Site Number 840011, Greensboro

27834

Investigational Site Number 840047, Greenville

28144

Investigational Site Number 840016, Salisbury

28209

Investigational Site Number 840009, Charlotte

28401

Investigational Site Number 840012, Wilmington

28805

Investigational Site Number 840048, Asheville

29010

Investigational Site Number 724006, Málaga

29605

Investigational Site Number 840059, Greenville

29651

Investigational Site Number 840015, Greer

30076

Investigational Site Number 840041, Roswell

30189

Investigational Site Number 840042, Woodstock

30461

Investigational Site Number 840053, Statesboro

33156

Investigational Site Number 840010, Miami

Investigational Site Number 840035, Miami

34208

Investigational Site Number 840030, Bradenton

34652

Investigational Site Number 840014, New Port Richey

34684

Investigational Site Number 840056, Palm Harbor

34761

Investigational Site Number 840051, Ocoee

36571

Investigational Site Number 840058, Saraland

37404

Investigational Site Number 840002, Chattanooga

Investigational Site Number 840046, Chattanooga

37912

Investigational Site Number 840034, Knoxville

40138

Investigational Site Number 380004, Bologna

41071

Investigational Site Number 724005, Seville

44093

Investigational Site Number 250006, Nantes

44150

Investigational Site Number 484001, Guadalajara

44281

Investigational Site Number 840054, Wadsworth

45219

Investigational Site Number 840072, Cincinnati

45359

Investigational Site Number 276003, Essen

46123

Investigational Site Number 840013, Avon

Investigational Site Number 840023, Avon

46600

Investigational Site Number 724004, Alzira

46930

Investigational Site Number 724007, Quart de Poblet

47304

Investigational Site Number 840006, Muncie

47714

Investigational Site Number 840039, Evansville

48504

Investigational Site Number 840020, Flint

50266

Investigational Site Number 840033, West Des Moines

50314

Investigational Site Number 840026, Des Moines

58103

Investigational Site Number 840022, Fargo

60005

Investigational Site Number 840005, Arlington Heights

61602

Investigational Site Number 840004, Peoria

62250

Investigational Site Number 484004, Cuernavaca

62704

Investigational Site Number 840029, Springfield

64460

Investigational Site Number 484003, Monterrey

66013

Investigational Site Number 380005, Chieti

66209

Investigational Site Number 840032, Overland Park

66740

Investigational Site Number 276002, Saarlouis

69495

Investigational Site Number 250004, Lyon

70006

Investigational Site Number 840069, Metairie

75039

Investigational Site Number 840024, Irving

75230

Investigational Site Number 840001, Dallas

76014

Investigational Site Number 840055, Arlington

76180

Investigational Site Number 840061, North Richland Hills

77469

Investigational Site Number 840028, Richmond

78230

Investigational Site Number 840063, San Antonio

79530

Investigational Site Number 752003, Rättvik

80020

Investigational Site Number 170007, Barranquilla

80501

Investigational Site Number 840027, Longmont

81925

Investigational Site Number 276001, München

84790

Investigational Site Number 840038, St. George

86021

Investigational Site Number 250005, Poitiers

90057

Investigational Site Number 840064, Los Angeles

90255

Investigational Site Number 840070, Huntington Park

90650

Investigational Site Number 840031, Norwalk

92591

Investigational Site Number 840003, Temecula

92868

Investigational Site Number 840050, Orange

93065

Investigational Site Number 840036, Simi Valley

93720

Investigational Site Number 840019, Fresno

93722

Investigational Site Number 840021, Fresno

94598

Investigational Site Number 840062, Walnut Creek

94612

Investigational Site Number 840065, Oakland

94904

Investigational Site Number 840040, Greenbrae

97330

Investigational Site Number 840057, Corvallis

97702

Investigational Site Number 840067, Bend

98003

Investigational Site Number 840025, Federal Way

110221

Investigational Site Number 170001, Bogotá

111311

Investigational Site Number 170005, Bogotá

170004

Investigational Site Number 170003, Manizales

410159

Investigational Site Number 642004, Oradea

540142

Investigational Site Number 642002, Târgu Mureş

Investigational Site Number 642003, Târgu Mureş

550371

Investigational Site Number 642005, Sibiu

600154

Investigational Site Number 642006, Bacau

630004

Investigational Site Number 170004, Armenia

900675

Investigational Site Number 642007, Constanța

Unknown

Investigational Site Number 840007, St. Petersburg

Investigational Site Number 392008, Adachi-Ku

Investigational Site Number 392003, Atsugi-Shi

Investigational Site Number 392002, Kamakura-Shi

Investigational Site Number 392010, Sagamihara-Shi

Investigational Site Number 392004, Sakado-Shi

Investigational Site Number 392013, Sapporo

Investigational Site Number 392012, Sendai

Investigational Site Number 604004, Arequipa

03063

Investigational Site Number 840037, Nashua

L6S 0C9

Investigational Site Number 124003, Brampton

L7M 4Y1

Investigational Site Number 124005, Burlington

N7L 1C1

Investigational Site Number 124008, Chatham

J7J 2K8

Investigational Site Number 124010, Mirabel

H2X 0A9

Investigational Site Number 124009, Montreal

G1W4R4

Investigational Site Number 124006, Sainte-Foy

L4J 8L7

Investigational Site Number 124004, Thornhill

M4G 3E8

Investigational Site Number 124002, Toronto

V5Y 3W2

Investigational Site Number 124001, Vancouver

V5Z 1L8

Investigational Site Number 124007, Vancouver

01307

Investigational Site Number 276004, Dresden

056

Investigational Site Number 604007, Ica

Lima 09

Investigational Site Number 604005, Lima

LIMA 14

Investigational Site Number 604001, Lima

Lima 32

Investigational Site Number 604006, Lima

20-538

Investigational Site Number 616005, Lublin

70-506

Investigational Site Number 616004, Szczecin

02-507

Investigational Site Number 616003, Warsaw

03-242

Investigational Site Number 616002, Warsaw

41-800

Investigational Site Number 616001, Zabrze

020042

Investigational Site Number 642001, Bucharest

110-744

Investigational Site Number 410003, Seoul

110-746

Investigational Site Number 410005, Seoul

135-710

Investigational Site Number 410002, Seoul

136-705

Investigational Site Number 410001, Seoul

220-701

Investigational Site Number 410004, Wŏnju

08916

Investigational Site Number 724001, Badalona

405 45

Investigational Site Number 752002, Gothenburg

871 82

Investigational Site Number 752004, Härnösand

421 44

Investigational Site Number 752001, Västra Frölunda

BT12 6BA

Investigational Site Number 826003, Belfast

BT16 1RH

Investigational Site Number 826005, Belfast

BS10 5NB

Investigational Site Number 826001, Bristol

RH1 5RH

Investigational Site Number 826004, Redhill

S60 2UD

Investigational Site Number 826006, Rotherham

SA2 8PP

Investigational Site Number 826002, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY