Primary Objective:
To demonstrate non-inferiority of SAR342434 versus Humalog in HbA1c change in patients with
type 1 diabetes mellitus (T1DM) also using insulin glargine.
Secondary Objectives:
To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status
and antibody titers at baseline and during the course of the study.
To assess the relationship of anti-insulin antibodies with efficacy and safety including
during the safety extension.
To assess the efficacy of SAR342434 and Humalog in terms of proportion of patients reaching
target HbA1c (<7%) and on fasting plasma glucose (FPG), self-measured plasma glucose (SMPG)
profiles, and insulin dose.
To assess safety of SAR342434 and Humalog.
- The maximum study duration will then be 54 weeks per patient and a 1-day safety
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Investigational Site Number 250002, Corbeil Essonnes 91109, France
Investigational Site Number 250005, Mantes La Jolie 78200, France
Investigational Site Number 250003, Montpellier Cedex 5 34295, France
Investigational Site Number 250001, Vandoeuvre Les Nancy 54511, France
Investigational Site Number 276001, Berlin 10115, Germany
Investigational Site Number 276004, Dortmund 44137, Germany
Investigational Site Number 276006, Hannover 30159, Germany
Investigational Site Number 276002, Heidelberg 69115, Germany
Investigational Site Number 276003, NeumĂĽnster 24534, Germany
Investigational Site Number 276008, Pirna 01796, Germany
Investigational Site Number 276007, Potsdam 14469, Germany
Investigational Site Number 276005, Sulzbach-Rosenberg 92237, Germany
Investigational Site Number 348001, Budapest 1213, Hungary
Investigational Site Number 348002, Budapest 1023, Hungary
Investigational Site Number 348003, Budapest 1134, Hungary
Investigational Site Number 348005, Budapest 1033, Hungary
Investigational Site Number 348010, Budapest 1139, Hungary
Investigational Site Number 348011, Budapest 1062, Hungary
Investigational Site Number 348007, Debrecen 4031, Hungary
Investigational Site Number 392006, Chuo-Ku, Japan
Investigational Site Number 392003, Higashiosaka-Shi, Japan
Investigational Site Number 392004, Izumisano-Shi, Japan
Investigational Site Number 392005, Kamakura-Shi, Japan
Investigational Site Number 392001, Shinjuku-Ku, Japan
Investigational Site Number 392002, Yamato-Shi, Japan
Investigational Site Number 616005, Krakow 31-501, Poland
Investigational Site Number 616001, Poznan 60-834, Poland
Investigational Site Number 616003, Szczecin 70-506, Poland
Investigational Site Number 616002, Warszawa 02-507, Poland
Investigational Site Number 616004, Zabrze 41-800, Poland
Investigational Site Number 643003, Moscow 117036, Russian Federation
Investigational Site Number 643006, Samara 443067, Russian Federation
Investigational Site Number 643002, Saratov 410030, Russian Federation
Investigational Site Number 643001, St-Petersburg 194354, Russian Federation
Investigational Site Number 643004, St-Petersburg 190068, Russian Federation
Investigational Site Number 643005, St-Petersburg 195257, Russian Federation
Investigational Site Number 643007, Tomsk 634050, Russian Federation
Investigational Site Number 724001, Cáceres 10003, Spain
Investigational Site Number 724002, La Coruña 15006, Spain
Investigational Site Number 724004, LĂ©rida 25198, Spain
Investigational Site Number 724005, Málaga 29010, Spain
Investigational Site Number 724003, Sabadell 08208, Spain
Investigational Site Number 840049, Tucosn, Arizona 85714, United States
Investigational Site Number 840016, Bell Gardens, California 90201, United States
Investigational Site Number 840048, Chula Vista, California 91911, United States
Investigational Site Number 840046, Concord, California 94520, United States
Investigational Site Number 840039, Fresno, California 93720, United States
Investigational Site Number 840028, La Jolla, California 92037, United States
Investigational Site Number 840022, Ventura, California 93003, United States
Investigational Site Number 840003, Denver, Colorado 80209, United States
Investigational Site Number 840037, Denver, Colorado 80262, United States
Investigational Site Number 840005, Bradenton, Florida 34208, United States
Investigational Site Number 840057, Miami Lakes, Florida 33016, United States
Investigational Site Number 840061, Miami Lakes, Florida 33014, United States
Investigational Site Number 840042, Miami, Florida 33176, United States
Investigational Site Number 840050, Miami, Florida 33155, United States
Investigational Site Number 840006, New Port Richey, Florida 34652, United States
Investigational Site Number 840013, North Miami Beach, Florida 33162, United States
Investigational Site Number 840031, Port Charlotte, Florida 33952, United States
Investigational Site Number 840036, Atlanta, Georgia 30318, United States
Investigational Site Number 840045, Roswell, Georgia 30076, United States
Investigational Site Number 840020, Idaho Falls, Idaho 83404, United States
Investigational Site Number 840019, Chicago, Illinois 60607, United States
Investigational Site Number 840033, Chicago, Illinois 60612, United States
Investigational Site Number 840012, Mchenry, Illinois 60050, United States
Investigational Site Number 840004, Des Moines, Iowa 50314, United States
Investigational Site Number 840043, Marrero, Louisiana 70072, United States
Investigational Site Number 840021, Metairie, Louisiana 70006, United States
Investigational Site Number 840044, Monroe, Louisiana 71201, United States
Investigational Site Number 840038, Baltimore, Maryland 21237, United States
Investigational Site Number 840014, Rockville, Maryland 20852, United States
Investigational Site Number 840060, Great Falls, Montana 59405, United States
Investigational Site Number 840026, Omaha, Nebraska 68114, United States
Investigational Site Number 840040, Omaha, Nebraska 68131, United States
Investigational Site Number 840015, Albuquerque, New Mexico 87106, United States
Investigational Site Number 840054, Albuquerque, New Mexico 87109, United States
Investigational Site Number 840059, Mineola, New York 11501, United States
Investigational Site Number 840030, Burlington, North Carolina 27215, United States
Investigational Site Number 840051, Greenville, North Carolina 27834, United States
Investigational Site Number 840062, Wilmington, North Carolina 28401, United States
Investigational Site Number 840018, Gallipolis, Ohio 45631, United States
Investigational Site Number 840007, Dakota Dunes, South Dakota 57049, United States
Investigational Site Number 840027, Rapid City, South Dakota 57701, United States
Investigational Site Number 840029, Dallas, Texas 75231, United States
Investigational Site Number 840034, Dallas, Texas 75246, United States
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Investigational Site Number 840002, Houston, Texas 77090, United States
Investigational Site Number 840011, Chesapeake, Virginia 23321, United States
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Investigational Site Number 840009, Milwaukee, Wisconsin 53209-0996, United States