NCT01499095 - Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy | Biotech Hunter

Enrollment

811

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

November 30, 2013

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG

Lantus (Insulin glargine)

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

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 in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4 - 5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.

Trial Locations (213)

1032

Investigational Site Number 348005, Budapest

1139

Investigational Site Number 348003, Budapest

1145

Investigational Site Number 348010, Budapest

1204

Investigational Site Number 348009, Budapest

1459

Investigational Site Number 710002, Boksburg

1501

Investigational Site Number 710007, Benoni

2013

Investigational Site Number 710001, Johannesburg

3300

Investigational Site Number 348002, Eger

3980

Investigational Site Number 348007, Sátorlaljaújhely

4170

Investigational Site Number 710008, eMkhomazi

4200

Investigational Site Number 620004, Porto

6500

Investigational Site Number 348006, Baja

6900

Investigational Site Number 348001, Makó

7130

Investigational Site Number 710003, Cape Town

Investigational Site Number 710012, Somerset West

7500

Investigational Site Number 710010, Cape Town

8500

Investigational Site Number 348004, Pápa

9200

Investigational Site Number 348008, Mosonmagyaróvár

9301

Investigational Site Number 710006, Bloemfontein

Investigational Site Number 710014, Bloemfontein

11550

Investigational Site Number 484006, Mexico City

15401

Investigational Site Number 840005, Uniontown

16684

Investigational Site Number 840148, Tipton

17019

Investigational Site Number 250001, La Rochelle

20475

Investigational Site Number 642001, Bucharest

Investigational Site Number 642002, Bucharest

20852

Investigational Site Number 840031, Rockville

21237

Investigational Site Number 840034, Baltimore

Investigational Site Number 840150, Baltimore

22601

Investigational Site Number 840134, Winchester

23185

Investigational Site Number 840072, Williamsburg

23235

Investigational Site Number 840095, Richmond

23321

Investigational Site Number 840032, Chesapeake

23510

Investigational Site Number 840040, Norfolk

24534

Investigational Site Number 276003, Neumünster

27103

Investigational Site Number 840024, Winston-Salem

28401

Investigational Site Number 840047, Wilmington

28467

Investigational Site Number 840140, Calabash

28601

Investigational Site Number 840139, Hickory

Investigational Site Number 840153, Hickory

29010

Investigational Site Number 724003, Málaga

29651

Investigational Site Number 840076, Greer

29681

Investigational Site Number 840503, Simpsonville

31901

Investigational Site Number 840528, Columbus

32117

Investigational Site Number 840049, Daytona Beach

32258

Investigational Site Number 840008, Jacksonville

33015

Investigational Site Number 840520, Miami

33029

Investigational Site Number 840513, Pembroke Pines

33511

Investigational Site Number 840518, Brandon

34652

Investigational Site Number 840025, New Port Richey

34684

Investigational Site Number 840141, Palm Harbor

34761

Investigational Site Number 840011, Ocoee

35213

Investigational Site Number 840517, Birmingham

37404

Investigational Site Number 840038, Chattanooga

37620

Investigational Site Number 840028, Bristol

37912

Investigational Site Number 840042, Knoxville

38119

Investigational Site Number 840160, Memphis

38125

Investigational Site Number 840033, Memphis

39531

Investigational Site Number 840158, Biloxi

39670

Investigational Site Number 484009, Acapulco

41010

Investigational Site Number 724002, Seville

42003

Investigational Site Number 840041, Paducah

42060

Investigational Site Number 484004, Pachuca

43213

Investigational Site Number 840097, Columbus

43537

Investigational Site Number 840108, Maumee

44093

Investigational Site Number 250002, Nantes

44210

Investigational Site Number 484007, Guadalajara

44656

Investigational Site Number 484008, Guadalajara

45236

Investigational Site Number 840007, Cincinnati

45439

Investigational Site Number 840113, Dayton

46014

Investigational Site Number 724004, Valancia

46045

Investigational Site Number 276008, Oberhausen

46123

Investigational Site Number 840045, Avon

Investigational Site Number 840077, Avon

Investigational Site Number 840088, Avon

Investigational Site Number 840089, Avon

Investigational Site Number 840091, Avon

47714

Investigational Site Number 840130, Evansville

47904

Investigational Site Number 840142, Lafayette

48034

Investigational Site Number 840023, Southfield

48106

Investigational Site Number 840063, Ann Arbor

48124

Investigational Site Number 840064, Dearborn

48504

Investigational Site Number 840094, Flint

55122

Investigational Site Number 840066, Eagan

55416

Investigational Site Number 840081, Minneapolis

57701

Investigational Site Number 840048, Rapid City

58103

Investigational Site Number 840065, Fargo

59701

Investigational Site Number 840502, Butte

60050

Investigational Site Number 840021, McHenry

60612

Investigational Site Number 840199, Chicago

62704

Investigational Site Number 840020, Springfield

63017

Investigational Site Number 840526, Chesterfield

64020

Investigational Site Number 484001, Monterrey

64240

Investigational Site Number 484003, Monterrey

66780

Investigational Site Number 276007, Rehlingen-Siersburg

67000

Investigational Site Number 250009, Strasbourg

68025

Investigational Site Number 840084, Fremont

68130

Investigational Site Number 840085, Omaha

69200

Investigational Site Number 250003, Vénissieux

71200

Investigational Site Number 250004, Le Creusot

71913

Investigational Site Number 840015, Hot Springs

72143

Investigational Site Number 840027, Searcy

72205

Investigational Site Number 840014, Little Rock

Investigational Site Number 840114, Little Rock

72653

Investigational Site Number 840018, Mountain Home

75230

Investigational Site Number 840001, Dallas

75231

Investigational Site Number 840159, Dallas

75246

Investigational Site Number 840115, Dallas

77030

Investigational Site Number 840079, Houston

77074

Investigational Site Number 840514, Houston

78200

Investigational Site Number 250005, Mantes-la-Jolie

78229

Investigational Site Number 840525, San Antonio

78258

Investigational Site Number 840161, San Antonio

78404

Investigational Site Number 840519, Corpus Christi

78731

Investigational Site Number 840022, Austin

78758

Investigational Site Number 840078, Austin

80206

Investigational Site Number 840098, Denver

80906

Investigational Site Number 840104, Colorado Springs

80909

Investigational Site Number 840128, Colorado Springs

83404

Investigational Site Number 840050, Idaho Falls

83686

Investigational Site Number 840107, Nampa

84020

Investigational Site Number 840009, Draper

84058

Investigational Site Number 840037, Orem

84107

Investigational Site Number 840510, Salt Lake City

85028

Investigational Site Number 840069, Phoenix

85224

Investigational Site Number 840149, Chandler

85282

Investigational Site Number 840068, Tempe

85306

Investigational Site Number 840093, Glendale

85351

Investigational Site Number 840110, Sun City

88239

Investigational Site Number 276005, Wangen

89102

Investigational Site Number 840162, Las Vegas

89117

Investigational Site Number 840527, Las Vegas

89148

Investigational Site Number 840056, Las Vegas

90073

Investigational Site Number 840026, Los Angeles

90201

Investigational Site Number 840509, Bell Gardens

91345

Investigational Site Number 840090, Mission Hills

91942

Investigational Site Number 840003, La Mesa

92037

Investigational Site Number 840057, La Jolla

92161

Investigational Site Number 840004, San Diego

92262

Investigational Site Number 840099, Palm Springs

92780

Investigational Site Number 840012, Tustin

92801

Investigational Site Number 840074, Anaheim

93110

Investigational Site Number 840124, Santa Barbara

94550

Investigational Site Number 276004, Künzing

94904

Investigational Site Number 840060, Greenbrae

97504

Investigational Site Number 840080, Medford

98502

Investigational Site Number 840523, Olympia

99362

Investigational Site Number 840122, Walla Walla

100097

Investigational Site Number 642010, Ploieşti

123423

Investigational Site Number 643010, Moscow

129110

Investigational Site Number 643007, Moscow

194291

Investigational Site Number 643009, Saint Petersburg

194354

Investigational Site Number 643006, Saint Petersburg

Investigational Site Number 643014, Saint Petersburg

194358

Investigational Site Number 643008, Saint Petersburg

195112

Investigational Site Number 643013, Saint Petersburg

195257

Investigational Site Number 643004, Saint Petersburg

198013

Investigational Site Number 643001, Saint Petersburg

300133

Investigational Site Number 642012, Timișoara

300456

Investigational Site Number 642005, Timișoara

320076

Investigational Site Number 642004, Reşiţa

330084

Investigational Site Number 642006, Deva

331057

Investigational Site Number 642011, Hunedoara

394018

Investigational Site Number 643005, Voronezh

400006

Investigational Site Number 642014, Cluj-Napoca

410030

Investigational Site Number 643002, Saratov

410169

Investigational Site Number 642013, Oradea

443095

Investigational Site Number 643011, Samara

450000

Investigational Site Number 643016, Ufa

500365

Investigational Site Number 642009, Brasov

540142

Investigational Site Number 642007, Târgu Mureş

600164

Investigational Site Number 642008, Bacau

700547

Investigational Site Number 642015, Iași

2841959

Investigational Site Number 152012, Rancagua

4813299

Investigational Site Number 152006, Temuco

5311092

Investigational Site Number 152014, Osorno

7500010

Investigational Site Number 152005, Santiago

7500710

Investigational Site Number 152004, Santiago

7980378

Investigational Site Number 152001, Santiago

Investigational Site Number 152013, Santiago

8053095

Investigational Site Number 152007, Santiago

80004005

Investigational Site Number 152002, Santiago

07901

Investigational Site Number 840135, Summit

08721

Investigational Site Number 840145, Toms River

08753

Investigational Site Number 840087, Toms River

Unknown

Investigational Site Number 840504, Eugene

Investigational Site Number 152010, Santiago

Investigational Site Number 620007, Matosinhos Municipality

53209-0996

Investigational Site Number 840019, Milwaukee

L0R 1B0

Investigational Site Number 124024, Beamsville

L7M 4Y1

Investigational Site Number 124025, Burlington

T2N 4L7

Investigational Site Number 124020, Calgary

V2P 4M9

Investigational Site Number 124019, Chilliwack

V3K 3P4

Investigational Site Number 124018, Coquitlam

T5C 0A3

Investigational Site Number 124016, Edmonton

L8N 3Z5

Investigational Site Number 124014, Hamilton

J7J 2K8

Investigational Site Number 124004, Mirabel

L5M 2V8

Investigational Site Number 124026, Mississauga

T4N 6V7

Investigational Site Number 124002, Red Deer

J1H 5N4

Investigational Site Number 124013, Sherbrooke

M5C 2T2

Investigational Site Number 124011, Toronto

V8V 4A1

Investigational Site Number 124010, Victoria

R3E 3P4

Investigational Site Number 124022, Winnipeg

751-0009

Investigational Site Number 152003, Santiago

56 63

Investigational Site Number 152009, Valdivia

00290

Investigational Site Number 246001, Helsinki

01796

Investigational Site Number 276009, Pirna

Guadalajara

Investigational Site Number 484010, Guadalajara

020475

Investigational Site Number 642003, Bucharest

0001

Investigational Site Number 710005, Pretoria

08022

Investigational Site Number 724005, Barcelona

07198

Investigational Site Number 724006, Palma de Mallorca

08208

Investigational Site Number 724001, Sabadell