878
Participants
Start Date
August 31, 2012
Primary Completion Date
September 30, 2013
Study Completion Date
March 31, 2014
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 \[mg/dL\]).
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).
Investigational Site Number 246208, Helsinki
Investigational Site Number 840709, Cagua
Investigational Site Number 840703, San Juan
Investigational Site Number 840708, San Juan
Investigational Site Number 840706, Carolina
Investigational Site Number 428206, Riga
Investigational Site Number 348201, Budapest
Investigational Site Number 348207, Budapest
Investigational Site Number 348212, Budapest
Investigational Site Number 348210, Budapest
Investigational Site Number 100206, Sofia
Investigational Site Number 840253, Haverhill
Investigational Site Number 208207, København NV
Investigational Site Number 208206, Hvidovre
Investigational Site Number 348205, Balassagyarmat
Investigational Site Number 100205, Blagoevgrad
Investigational Site Number 208202, Herlev
Investigational Site Number 208209, Hellerup
Investigational Site Number 100201, Plovdiv
Investigational Site Number 100204, Plovdiv
Investigational Site Number 208201, Odense C
Investigational Site Number 208210, Kolding
Investigational Site Number 208203, Esbjerg
Investigational Site Number 100203, Byala
Investigational Site Number 348202, Úrhida
Investigational Site Number 208204, Viborg
Investigational Site Number 208205, Aalborg
Investigational Site Number 203203, Prague
Investigational Site Number 840310, New Hyde Park
Investigational Site Number 752201, Stockholm
Investigational Site Number 233204, Tallinn
Investigational Site Number 752204, Vällingby
Investigational Site Number 840308, Tipton
Investigational Site Number 203202, Prague
Investigational Site Number 840240, Philadelphia
Investigational Site Number 246205, Turku
Investigational Site Number 840206, Manassas
Investigational Site Number 642201, Bucharest
Investigational Site Number 840301, Rockville
Investigational Site Number 840208, Baltimore
Investigational Site Number 840239, Burke
Investigational Site Number 840296, Greensboro
Investigational Site Number 840275, Morganton
Investigational Site Number 840247, Asheville
Investigational Site Number 752205, Kristianstad
Investigational Site Number 840237, Spartanburg
Investigational Site Number 840252, Greer
Investigational Site Number 840323, Stockbridge
Investigational Site Number 840245, Atlanta
Investigational Site Number 840226, Jacksonville
Investigational Site Number 840318, Jacksonville
Investigational Site Number 840224, Jacksonville
Investigational Site Number 840216, Oviedo
Investigational Site Number 840291, Orlando
Investigational Site Number 840316, Orlando
Investigational Site Number 840204, Hialeah
Investigational Site Number 840248, Hollywood
Investigational Site Number 840288, Pembroke Pines
Investigational Site Number 246206, Tampere
Investigational Site Number 840212, Coral Gables
Investigational Site Number 840266, Coral Gables
Investigational Site Number 840337, Miami Beach
Investigational Site Number 840228, Miami
Investigational Site Number 840238, Miami
Investigational Site Number 840303, North Miami Beach
Investigational Site Number 840302, Miami
Investigational Site Number 840339, West Palm Beach
Investigational Site Number 840299, Boca Raton
Investigational Site Number 840285, Boynton Beach
Investigational Site Number 840251, Tampa
Investigational Site Number 840309, St. Petersburg
Investigational Site Number 840233, Clearwater
Investigational Site Number 840325, Port Charlotte
Investigational Site Number 840221, Bradenton
Investigational Site Number 840225, Ocala
Investigational Site Number 840227, New Port Richey
Investigational Site Number 840332, Palm Harbor
Investigational Site Number 840324, Montgomery
Investigational Site Number 840262, Chattanooga
Investigational Site Number 840260, Bristol
Investigational Site Number 840344, Lexington
Investigational Site Number 840231, Murray
Investigational Site Number 840307, Columbus
Investigational Site Number 840330, Cleveland
Investigational Site Number 840314, Avon
Investigational Site Number 840317, Avon
Investigational Site Number 840270, Madison Heights
Investigational Site Number 440203, Kaunas
Investigational Site Number 840214, Des Moines
Investigational Site Number 233203, Tartu
Investigational Site Number 233205, Tartu
Investigational Site Number 840294, Dakota Dunes
Investigational Site Number 840278, Chicago
Investigational Site Number 840320, Chicago
Investigational Site Number 203201, Brno
Investigational Site Number 840276, Springfield
Investigational Site Number 203205, Brno
Investigational Site Number 840232, Overland Park
Investigational Site Number 840287, Topeka
Investigational Site Number 246202, Kokkola
Investigational Site Number 840300, Omaha
Investigational Site Number 840210, Omaha
Investigational Site Number 840263, Omaha
Investigational Site Number 840348, Metairie
Investigational Site Number 840290, New Orleans
Investigational Site Number 840304, Little Rock
Investigational Site Number 840229, Norman
Investigational Site Number 203204, Havířov
Investigational Site Number 840268, Dallas
Investigational Site Number 840292, Dallas
Investigational Site Number 840315, Dallas
Investigational Site Number 840242, Dallas
Investigational Site Number 840338, Houston
Investigational Site Number 840218, Houston
Investigational Site Number 840328, Houston
Investigational Site Number 840259, Houston
Investigational Site Number 840327, Pearland
Investigational Site Number 840282, San Antonio
Investigational Site Number 840342, Corpus Christi
Investigational Site Number 840326, Edinburg
Investigational Site Number 840331, Denver
Investigational Site Number 840249, Colorado Springs
Investigational Site Number 840283, Idaho Falls
Investigational Site Number 840343, Salt Lake City
Investigational Site Number 840202, Murray
Investigational Site Number 840211, Phoenix
Investigational Site Number 840220, Peoria
Investigational Site Number 840207, Phoenix
Investigational Site Number 703203, Bratislava
Investigational Site Number 840217, Mesa
Investigational Site Number 840273, Chandler
Investigational Site Number 840264, Tempe
Investigational Site Number 840269, Albuquerque
Investigational Site Number 840349, Las Vegas
Investigational Site Number 840201, Las Vegas
Investigational Site Number 840256, Las Vegas
Investigational Site Number 246207, Oulu
Investigational Site Number 840347, Bell Gardens
Investigational Site Number 840297, Torrance
Investigational Site Number 840222, Long Beach
Investigational Site Number 840235, La Mesa
Investigational Site Number 840274, La Mesa
Investigational Site Number 840250, Spring Valley
Investigational Site Number 840244, Escondido
Investigational Site Number 840230, La Jolla
Investigational Site Number 840243, Palm Springs
Investigational Site Number 840209, Temecula
Investigational Site Number 840267, Huntington Beach
Investigational Site Number 840272, Tustin
Investigational Site Number 703201, Levice
Investigational Site Number 840257, Fresno
Investigational Site Number 840223, Walnut Creek
Investigational Site Number 840213, Greenbrae
Investigational Site Number 703206, Levice
Investigational Site Number 840236, Honolulu
Investigational Site Number 703205, Banská Bystrica
Investigational Site Number 840219, Bend
Investigational Site Number 840246, Renton
Investigational Site Number 703207, Lučenec
Investigational Site Number 642206, Timișoara
Investigational Site Number 642209, Timișoara
Investigational Site Number 642207, Reşiţa
Investigational Site Number 642202, Cluj-Napoca
Investigational Site Number 642213, Oradea
Investigational Site Number 642203, Târgu Mureş
Investigational Site Number 642204, Târgu Mureş
Investigational Site Number 642205, Sibiu
Investigational Site Number 642208, Bacau
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
Investigational Site Number 840289, Fall River
Investigational Site Number 840306, Hamilton
Investigational Site Number 840203, Sea Girt
Investigational Site Number 840295, Sicklerville
Investigational Site Number 840311, Milwaukee
Investigational Site Number 124204, Brampton
Investigational Site Number 124211, Etobicoke
Investigational Site Number 124208, Laval
Investigational Site Number 124214, London
Investigational Site Number 124210, Montreal
Investigational Site Number 124218, Montreal
Investigational Site Number 124206, Pointe-Claire
Investigational Site Number 124216, Saint-Laurent
Investigational Site Number 124219, Sherbrooke
Investigational Site Number 124201, Thornhill
Investigational Site Number 124209, Thornhill
Investigational Site Number 124212, Toronto
Investigational Site Number 428203, Riga
Investigational Site Number 428205, Riga
Investigational Site Number 428202, Sigulda
Investigational Site Number 428201, Ventspils
Investigational Site Number 440204, Kaunas
Investigational Site Number 440201, Klaipėda
Investigational Site Number 440202, Klaipėda
Investigational Site Number 440205, Vilnius
Investigational Site Number 528204, Almere Stad
Investigational Site Number 528209, Beek
Investigational Site Number 528205, Breda
Investigational Site Number 528207, Leiderdorp
Investigational Site Number 528203, Rotterdam
Investigational Site Number 528202, Velp
Investigational Site Number 840704, San Juan
Investigational Site Number 840710, San Juan
Investigational Site Number 642212, Bucharest
Investigational Site Number 703202, Bardejov
Investigational Site Number 752206, Malmo
Lead Sponsor
Sanofi
INDUSTRY