Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

878

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

March 31, 2014

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

HOE901-U300 (new formulation of insulin glargine)

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).

DRUG

Lantus (insulin glargine)

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Trial Locations (217)

260

Investigational Site Number 246208, Helsinki

725

Investigational Site Number 840709, Cagua

917

Investigational Site Number 840703, San Juan

926

Investigational Site Number 840708, San Juan

987

Investigational Site Number 840706, Carolina

1024

Investigational Site Number 428206, Riga

1036

Investigational Site Number 348201, Budapest

Investigational Site Number 348207, Budapest

1083

Investigational Site Number 348212, Budapest

1134

Investigational Site Number 348210, Budapest

1431

Investigational Site Number 100206, Sofia

1830

Investigational Site Number 840253, Haverhill

2400

Investigational Site Number 208207, København NV

2650

Investigational Site Number 208206, Hvidovre

2660

Investigational Site Number 348205, Balassagyarmat

2700

Investigational Site Number 100205, Blagoevgrad

2730

Investigational Site Number 208202, Herlev

2900

Investigational Site Number 208209, Hellerup

4002

Investigational Site Number 100201, Plovdiv

Investigational Site Number 100204, Plovdiv

5000

Investigational Site Number 208201, Odense C

6000

Investigational Site Number 208210, Kolding

6700

Investigational Site Number 208203, Esbjerg

7100

Investigational Site Number 100203, Byala

8142

Investigational Site Number 348202, Úrhida

8800

Investigational Site Number 208204, Viborg

9100

Investigational Site Number 208205, Aalborg

10034

Investigational Site Number 203203, Prague

11042

Investigational Site Number 840310, New Hyde Park

11526

Investigational Site Number 752201, Stockholm

13419

Investigational Site Number 233204, Tallinn

16268

Investigational Site Number 752204, Vällingby

16684

Investigational Site Number 840308, Tipton

18100

Investigational Site Number 203202, Prague

19139

Investigational Site Number 840240, Philadelphia

20100

Investigational Site Number 246205, Turku

20110

Investigational Site Number 840206, Manassas

20475

Investigational Site Number 642201, Bucharest

20852

Investigational Site Number 840301, Rockville

21237

Investigational Site Number 840208, Baltimore

22015

Investigational Site Number 840239, Burke

27408

Investigational Site Number 840296, Greensboro

28655

Investigational Site Number 840275, Morganton

28803

Investigational Site Number 840247, Asheville

29185

Investigational Site Number 752205, Kristianstad

29303

Investigational Site Number 840237, Spartanburg

29651

Investigational Site Number 840252, Greer

30281

Investigational Site Number 840323, Stockbridge

30308

Investigational Site Number 840245, Atlanta

32205

Investigational Site Number 840226, Jacksonville

32216

Investigational Site Number 840318, Jacksonville

32258

Investigational Site Number 840224, Jacksonville

32765

Investigational Site Number 840216, Oviedo

32804

Investigational Site Number 840291, Orlando

32806

Investigational Site Number 840316, Orlando

33012

Investigational Site Number 840204, Hialeah

33021

Investigational Site Number 840248, Hollywood

33028

Investigational Site Number 840288, Pembroke Pines

33100

Investigational Site Number 246206, Tampere

33134

Investigational Site Number 840212, Coral Gables

Investigational Site Number 840266, Coral Gables

33141

Investigational Site Number 840337, Miami Beach

33144

Investigational Site Number 840228, Miami

Investigational Site Number 840238, Miami

33162

Investigational Site Number 840303, North Miami Beach

33176

Investigational Site Number 840302, Miami

33401

Investigational Site Number 840339, West Palm Beach

33432

Investigational Site Number 840299, Boca Raton

33472

Investigational Site Number 840285, Boynton Beach

33603

Investigational Site Number 840251, Tampa

33716

Investigational Site Number 840309, St. Petersburg

33765

Investigational Site Number 840233, Clearwater

33952

Investigational Site Number 840325, Port Charlotte

34208

Investigational Site Number 840221, Bradenton

34471

Investigational Site Number 840225, Ocala

34652

Investigational Site Number 840227, New Port Richey

34684

Investigational Site Number 840332, Palm Harbor

36109

Investigational Site Number 840324, Montgomery

37404

Investigational Site Number 840262, Chattanooga

37620

Investigational Site Number 840260, Bristol

40503

Investigational Site Number 840344, Lexington

42003

Investigational Site Number 840231, Murray

43213

Investigational Site Number 840307, Columbus

44122

Investigational Site Number 840330, Cleveland

46123

Investigational Site Number 840314, Avon

Investigational Site Number 840317, Avon

48071

Investigational Site Number 840270, Madison Heights

48259

Investigational Site Number 440203, Kaunas

50314

Investigational Site Number 840214, Des Moines

50406

Investigational Site Number 233203, Tartu

50410

Investigational Site Number 233205, Tartu

57049

Investigational Site Number 840294, Dakota Dunes

60607

Investigational Site Number 840278, Chicago

60612

Investigational Site Number 840320, Chicago

62500

Investigational Site Number 203201, Brno

62704

Investigational Site Number 840276, Springfield

65691

Investigational Site Number 203205, Brno

66210

Investigational Site Number 840232, Overland Park

66606

Investigational Site Number 840287, Topeka

67100

Investigational Site Number 246202, Kokkola

68105

Investigational Site Number 840300, Omaha

68131

Investigational Site Number 840210, Omaha

Investigational Site Number 840263, Omaha

70006

Investigational Site Number 840348, Metairie

70119

Investigational Site Number 840290, New Orleans

72205

Investigational Site Number 840304, Little Rock

73069

Investigational Site Number 840229, Norman

73601

Investigational Site Number 203204, Havířov

75230

Investigational Site Number 840268, Dallas

Investigational Site Number 840292, Dallas

75231

Investigational Site Number 840315, Dallas

75246

Investigational Site Number 840242, Dallas

77002

Investigational Site Number 840338, Houston

77004

Investigational Site Number 840218, Houston

77074

Investigational Site Number 840328, Houston

77095

Investigational Site Number 840259, Houston

77584

Investigational Site Number 840327, Pearland

78229

Investigational Site Number 840282, San Antonio

78404

Investigational Site Number 840342, Corpus Christi

78539

Investigational Site Number 840326, Edinburg

80212

Investigational Site Number 840331, Denver

80907

Investigational Site Number 840249, Colorado Springs

83404

Investigational Site Number 840283, Idaho Falls

84107

Investigational Site Number 840343, Salt Lake City

84123

Investigational Site Number 840202, Murray

85028

Investigational Site Number 840211, Phoenix

85050

Investigational Site Number 840220, Peoria

Investigational Site Number 840207, Phoenix

85101

Investigational Site Number 703203, Bratislava

85206

Investigational Site Number 840217, Mesa

85224

Investigational Site Number 840273, Chandler

85282

Investigational Site Number 840264, Tempe

87106

Investigational Site Number 840269, Albuquerque

89117

Investigational Site Number 840349, Las Vegas

89119

Investigational Site Number 840201, Las Vegas

89148

Investigational Site Number 840256, Las Vegas

90100

Investigational Site Number 246207, Oulu

90201

Investigational Site Number 840347, Bell Gardens

90502

Investigational Site Number 840297, Torrance

90806

Investigational Site Number 840222, Long Beach

91942

Investigational Site Number 840235, La Mesa

Investigational Site Number 840274, La Mesa

91978

Investigational Site Number 840250, Spring Valley

92025

Investigational Site Number 840244, Escondido

92037

Investigational Site Number 840230, La Jolla

92262

Investigational Site Number 840243, Palm Springs

92591

Investigational Site Number 840209, Temecula

92648

Investigational Site Number 840267, Huntington Beach

92780

Investigational Site Number 840272, Tustin

93405

Investigational Site Number 703201, Levice

93720

Investigational Site Number 840257, Fresno

94598

Investigational Site Number 840223, Walnut Creek

94904

Investigational Site Number 840213, Greenbrae

95401

Investigational Site Number 703206, Levice

96814

Investigational Site Number 840236, Honolulu

97517

Investigational Site Number 703205, Banská Bystrica

97701

Investigational Site Number 840219, Bend

98055

Investigational Site Number 840246, Renton

98401

Investigational Site Number 703207, Lučenec

300133

Investigational Site Number 642206, Timișoara

300456

Investigational Site Number 642209, Timișoara

320076

Investigational Site Number 642207, Reşiţa

400006

Investigational Site Number 642202, Cluj-Napoca

410169

Investigational Site Number 642213, Oradea

540142

Investigational Site Number 642203, Târgu Mureş

Investigational Site Number 642204, Târgu Mureş

550371

Investigational Site Number 642205, Sibiu

600164

Investigational Site Number 642208, Bacau

Unknown

Investigational Site Number 840234, Tempe

Investigational Site Number 392214, Fujimi

Investigational Site Number 392215, Fujimi

Investigational Site Number 392206, Ise-Shi

Investigational Site Number 392217, Kitaazumi-Gun

Investigational Site Number 392208, Matsumoto

Investigational Site Number 392210, Matsumoto-Shi

Investigational Site Number 392205, Midori

Investigational Site Number 392203, Mito

Investigational Site Number 392216, Sakai

Investigational Site Number 392213, Shimotsuke

Investigational Site Number 392218, Shunan-Shi

Investigational Site Number 392204, Yamagata

02720

Investigational Site Number 840289, Fall River

08619

Investigational Site Number 840306, Hamilton

08750

Investigational Site Number 840203, Sea Girt

08081

Investigational Site Number 840295, Sicklerville

53209-0996

Investigational Site Number 840311, Milwaukee

L6R 3J5

Investigational Site Number 124204, Brampton

M9R 4E1

Investigational Site Number 124211, Etobicoke

H7T 2P5

Investigational Site Number 124208, Laval

N6A 5G6

Investigational Site Number 124214, London

H1Y 3L1

Investigational Site Number 124210, Montreal

H4N 3C5

Investigational Site Number 124218, Montreal

H9R 4S3

Investigational Site Number 124206, Pointe-Claire

H4T 1Z9

Investigational Site Number 124216, Saint-Laurent

J1H 1Z1

Investigational Site Number 124219, Sherbrooke

L4J 8L7

Investigational Site Number 124201, Thornhill

Investigational Site Number 124209, Thornhill

M9W 4L9

Investigational Site Number 124212, Toronto

LV-1002

Investigational Site Number 428203, Riga

LV-1050

Investigational Site Number 428205, Riga

LV-2150

Investigational Site Number 428202, Sigulda

LV-3601

Investigational Site Number 428201, Ventspils

LT-49456

Investigational Site Number 440204, Kaunas

LT-92253

Investigational Site Number 440201, Klaipėda

LT-92304

Investigational Site Number 440202, Klaipėda

LT-08661

Investigational Site Number 440205, Vilnius

1311 RL

Investigational Site Number 528204, Almere Stad

6191 JW

Investigational Site Number 528209, Beek

4811 SW

Investigational Site Number 528205, Breda

2352 RA

Investigational Site Number 528207, Leiderdorp

3021 HC

Investigational Site Number 528203, Rotterdam

6883 ES

Investigational Site Number 528202, Velp

00917

Investigational Site Number 840704, San Juan

Investigational Site Number 840710, San Juan

020359

Investigational Site Number 642212, Bucharest

085 01

Investigational Site Number 703202, Bardejov

211 52

Investigational Site Number 752206, Malmo

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