505
Participants
Start Date
January 31, 2015
Primary Completion Date
February 29, 2016
Study Completion Date
February 29, 2016
SAR342434
SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by subcutaneous (SC) injection, immediately (within 5 -10 minutes) before meals intake. Dose adjusted to achieve 2 hour post prandial glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.
Humalog
Humalog 100 U/ml (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meals 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 hypoglycemia.
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.
Investigational Site Number 348205, Budapest
Investigational Site Number 348202, Budapest
Investigational Site Number 348208, Komárom
Investigational Site Number 348209, Sátoraljaújhely
Investigational Site Number 348204, Debrecen
Investigational Site Number 032203, Salta
Investigational Site Number 348203, Szolnok
Investigational Site Number 348210, Nagykanizsa
Investigational Site Number 276201, Berlin
Investigational Site Number 276206, Potsdam
Investigational Site Number 840243, Uniontown
Investigational Site Number 840250, Tipton
Investigational Site Number 380202, Sesto San Giovanni
Investigational Site Number 380201, Milan
Investigational Site Number 840239, Rockville
Investigational Site Number 276202, Neumünster
Investigational Site Number 840232, Greensboro
Investigational Site Number 840211, Morehead City
Investigational Site Number 840228, Morganton
Investigational Site Number 724203, Málaga
Investigational Site Number 840253, Lawrenceville
Investigational Site Number 840207, Stockbridge
Investigational Site Number 840246, Miami
Investigational Site Number 840214, Boynton Beach
Investigational Site Number 840242, Port Charlotte
Investigational Site Number 792201, Istanbul
Investigational Site Number 840226, New Port Richey
Investigational Site Number 840206, Palm Harbor
Investigational Site Number 840205, Ocoee
Investigational Site Number 792202, Istanbul
Investigational Site Number 792204, Izmir
Investigational Site Number 792203, Izmir
Investigational Site Number 840237, Muscle Shoals
Investigational Site Number 840217, Foley
Investigational Site Number 840208, Chattanooga
Investigational Site Number 840215, Jackson
Investigational Site Number 380203, Bologna
Investigational Site Number 840221, Columbus
Investigational Site Number 840255, Dayton
Investigational Site Number 840204, Avon
Investigational Site Number 840257, Evansville
Investigational Site Number 840236, Troy
Investigational Site Number 840230, Des Moines
Investigational Site Number 840225, Fargo
Investigational Site Number 840248, Arlington Heights
Investigational Site Number 840216, Lincoln
Investigational Site Number 276204, Heidelberg
Investigational Site Number 276205, Stuttgart
Investigational Site Number 840212, Little Rock
Investigational Site Number 840258, Dallas
Investigational Site Number 840201, Dallas
Investigational Site Number 840203, Austin
Investigational Site Number 840219, Phoenix
Investigational Site Number 840227, Phoenix
Investigational Site Number 840220, Las Vegas
Investigational Site Number 840233, Las Vegas
Investigational Site Number 840234, Los Angeles
Investigational Site Number 840247, Long Beach
Investigational Site Number 840235, Northridge
Investigational Site Number 840241, El Cajon
Investigational Site Number 276203, Sulzbach-Rosenberg
Investigational Site Number 840251, Palm Springs
Investigational Site Number 840223, Temecula
Investigational Site Number 840231, Huntington Beach
Investigational Site Number 840249, Santa Ana
Investigational Site Number 840259, Tustin
Investigational Site Number 840238, Fresno
Investigational Site Number 840240, Walnut Creek
Investigational Site Number 840229, Greenbrae
Investigational Site Number 840222, Renton
Investigational Site Number 643201, Saint Petersburg
Investigational Site Number 643203, Saint Petersburg
Investigational Site Number 643204, Saint Petersburg
Investigational Site Number 643202, Saint Petersburg
Investigational Site Number 642203, Timișoara
Investigational Site Number 642204, Deva
Investigational Site Number 642206, Cluj-Napoca
Investigational Site Number 643205, Saratov
Investigational Site Number 642205, Oradea
Investigational Site Number 642207, Târgu Mureş
Investigational Site Number 642208, Târgu Mureş
Investigational Site Number 642209, Sibiu
Investigational Site Number 642210, Bacau
Investigational Site Number 170203, Armenia
Investigational Site Number 152202, Santiago
Investigational Site Number 152204, Santiago
Investigational Site Number 152201, Santiago
Investigational Site Number 840245, Chandler
Investigational Site Number 840224, Linden
Investigational Site Number 032205, Ciudad Autonoma de Buenos Aire
Investigational Site Number 840209, Milwaukee
Investigational Site Number 032201, Caba
Investigational Site Number 032206, Capital Federal
Investigational Site Number 032202, Capital Federal
Investigational Site Number 380204, Roma
Investigational Site Number 642201, Bucharest
Investigational Site Number 642202, Bucharest
Investigational Site Number 410202, Seoul
Investigational Site Number 410204, Seoul
Investigational Site Number 410205, Seoul
Investigational Site Number 410201, Wŏnju
Investigational Site Number 724201, Barcelona
Investigational Site Number 724202, Palma de Mallorca
Lead Sponsor
Sanofi
INDUSTRY