NCT02273180 - Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine | Biotech Hunter

Enrollment

507

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

July 31, 2016

Conditions

Type 1 Diabetes Mellitus

Interventions

DRUG

SAR342434

SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by deep subcutaneous (SC) injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour post prandial plasma glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.

DRUG

Humalog

Humalog 100 U/mL (dose range of 1 unit to 60 units) self-administered by deep SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycaemia.

DRUG

Insulin glargine HOE901

Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.

Trial Locations (89)

1023

Investigational Site Number 348002, Budapest

1033

Investigational Site Number 348005, Budapest

1062

Investigational Site Number 348003, Budapest

Investigational Site Number 348011, Budapest

1139

Investigational Site Number 348010, Budapest

1213

Investigational Site Number 348001, Budapest

4031

Investigational Site Number 348007, Debrecen

10003

Investigational Site Number 724001, Cáceres

10115

Investigational Site Number 276001, Berlin

11501

Investigational Site Number 840059, Mineola

14469

Investigational Site Number 276007, Potsdam

15006

Investigational Site Number 724002, A Coruña

20852

Investigational Site Number 840014, Rockville

21237

Investigational Site Number 840038, Baltimore

23321

Investigational Site Number 840011, Chesapeake

24534

Investigational Site Number 276003, Neumünster

25198

Investigational Site Number 724004, Lleida

27215

Investigational Site Number 840030, Burlington

27834

Investigational Site Number 840051, Greenville

28401

Investigational Site Number 840062, Wilmington

29010

Investigational Site Number 724005, Málaga

30076

Investigational Site Number 840045, Roswell

30159

Investigational Site Number 276006, Hanover

30318

Investigational Site Number 840036, Atlanta

33014

Investigational Site Number 840061, Miami Lakes

33016

Investigational Site Number 840057, Miami Lakes

33155

Investigational Site Number 840050, Miami

33162

Investigational Site Number 840013, North Miami Beach

33176

Investigational Site Number 840042, Miami

33952

Investigational Site Number 840031, Port Charlotte

34208

Investigational Site Number 840005, Bradenton

34295

Investigational Site Number 250003, Montpellier

34652

Investigational Site Number 840006, New Port Richey

44137

Investigational Site Number 276004, Dortmund

45631

Investigational Site Number 840018, Gallipolis

50314

Investigational Site Number 840004, Des Moines

54511

Investigational Site Number 250001, Vandœuvre-lès-Nancy

57049

Investigational Site Number 840007, Dakota Dunes

57701

Investigational Site Number 840027, Rapid City

59405

Investigational Site Number 840060, Great Falls

60050

Investigational Site Number 840012, McHenry

60607

Investigational Site Number 840019, Chicago

60612

Investigational Site Number 840033, Chicago

68114

Investigational Site Number 840026, Omaha

68131

Investigational Site Number 840040, Omaha

69115

Investigational Site Number 276002, Heidelberg

70006

Investigational Site Number 840021, Metairie

70072

Investigational Site Number 840043, Marrero

75230

Investigational Site Number 840041, Dallas

75231

Investigational Site Number 840029, Dallas

75246

Investigational Site Number 840034, Dallas

77090

Investigational Site Number 840002, Houston

78200

Investigational Site Number 250005, Mantes-la-Jolie

80209

Investigational Site Number 840003, Denver

80262

Investigational Site Number 840037, Denver

83404

Investigational Site Number 840020, Idaho Falls

85714

Investigational Site Number 840049, Tucson

87106

Investigational Site Number 840015, Albuquerque

87109

Investigational Site Number 840054, Albuquerque

90201

Investigational Site Number 840016, Bell Gardens

91100

Investigational Site Number 250002, Corbeil-Essonnes

91910

Investigational Site Number 840048, Chula Vista

92037

Investigational Site Number 840028, La Jolla

92237

Investigational Site Number 276005, Sulzbach-Rosenberg

93003

Investigational Site Number 840022, Ventura

93720

Investigational Site Number 840039, Fresno

94520

Investigational Site Number 840046, Concord

117036

Investigational Site Number 643003, Moscow

190068

Investigational Site Number 643004, Saint Petersburg

194354

Investigational Site Number 643001, Saint Petersburg

195257

Investigational Site Number 643005, Saint Petersburg

410030

Investigational Site Number 643002, Saratov

443041

Investigational Site Number 643006, Samara

634050

Investigational Site Number 643007, Tomsk

98415-0299

Investigational Site Number 840023, Tacoma

53209-0996

Investigational Site Number 840009, Milwaukee

01796

Investigational Site Number 276008, Pirna

Unknown

Investigational Site Number 392006, Chūōku

Investigational Site Number 392003, Higashiosaka-Shi

Investigational Site Number 392004, Izumisano

Investigational Site Number 392005, Kamakura-Shi

Investigational Site Number 392001, Shinjuku-Ku

Investigational Site Number 392002, Yamato-Shi

31-501

Investigational Site Number 616005, Krakow

60-834

Investigational Site Number 616001, Poznan

70-506

Investigational Site Number 616003, Szczecin

02-507

Investigational Site Number 616002, Warsaw

41-800

Investigational Site Number 616004, Zabrze

08208

Investigational Site Number 724003, Sabadell