807
Participants
Start Date
December 31, 2011
Primary Completion Date
January 31, 2013
Study Completion Date
September 30, 2013
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 mealtime insulin analogue. 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.
Lantus (insulin glargine)
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
Investigational Site Number 348015, Budapest
Investigational Site Number 348013, Budapest
Investigational Site Number 348017, Budapest
Investigational Site Number 348009, Budapest
Investigational Site Number 710005, Alberton
Investigational Site Number 710006, Lenasia
Investigational Site Number 710003, Johannesburg
Investigational Site Number 348008, Eger
Investigational Site Number 348011, Sátorlaljaújhely
Investigational Site Number 348005, Debrecen
Investigational Site Number 348007, Nyiregyháza
Investigational Site Number 348018, Gyula
Investigational Site Number 348010, Baja
Investigational Site Number 348003, Szeged
Investigational Site Number 348014, Makó
Investigational Site Number 710004, Somerset West
Investigational Site Number 710001, Paarl
Investigational Site Number 710002, Observatory
Investigational Site Number 348004, Balatonfüred
Investigational Site Number 348001, Zalaegerszeg
Investigational Site Number 348012, Mosonmagyaróvár
Investigational Site Number 348006, Szombathely
Investigational Site Number 233004, Tallinn
Investigational Site Number 233006, Tallinn
Investigational Site Number 203008, Prague
Investigational Site Number 233003, Tallinn
Investigational Site Number 233001, Tallinn
Investigational Site Number 840007, Uniontown
Investigational Site Number 250004, La Rochelle
Investigational Site Number 840034, Rockville
Investigational Site Number 840036, Baltimore
Investigational Site Number 840155, Baltimore
Investigational Site Number 840075, Williamsburg
Investigational Site Number 840104, Richmond
Investigational Site Number 840035, Chesapeake
Investigational Site Number 840074, Norfolk
Investigational Site Number 840112, Norfolk
Investigational Site Number 840041, Norfolk
Investigational Site Number 203006, Beroun
Investigational Site Number 840045, Wilmington
Investigational Site Number 840145, Hickory
Investigational Site Number 840146, Asheville
Investigational Site Number 840079, Greer
Investigational Site Number 840055, Lawrenceville
Investigational Site Number 484007, Chihuahua City
Investigational Site Number 840049, Daytona Beach
Investigational Site Number 840086, Jacksonville
Investigational Site Number 840011, Jacksonville
Investigational Site Number 840009, Jacksonville
Investigational Site Number 840050, Hollywood
Investigational Site Number 840023, New Port Richey
Investigational Site Number 840148, Palm Harbor
Investigational Site Number 840012, Ocoee
Investigational Site Number 840039, Chattanooga
Investigational Site Number 840159, Knoxville
Investigational Site Number 840080, Lexington
Investigational Site Number 840042, Paducah
Investigational Site Number 484004, Pachuca
Investigational Site Number 840106, Columbus
Investigational Site Number 840119, Maumee
Investigational Site Number 840122, Mentor
Investigational Site Number 484006, Guadalajara
Investigational Site Number 840008, Cincinnati
Investigational Site Number 840123, Dayton
Investigational Site Number 840078, Avon
Investigational Site Number 840089, Avon
Investigational Site Number 840097, Avon
Investigational Site Number 840098, Avon
Investigational Site Number 840100, Avon
Investigational Site Number 840127, Vincennes
Investigational Site Number 840022, Southfield
Investigational Site Number 840065, Ann Arbor
Investigational Site Number 840066, Dearborn
Investigational Site Number 840103, Flint
Investigational Site Number 840126, Kalamazoo
Investigational Site Number 203003, Hradec Králové
Investigational Site Number 840116, Des Moines
Investigational Site Number 233005, Tartu
Investigational Site Number 840068, Eagan
Investigational Site Number 276003, Schwabenheim
Investigational Site Number 840143, Chaska
Investigational Site Number 840085, Minneapolis
Investigational Site Number 840048, Rapid City
Investigational Site Number 840067, Fargo
Investigational Site Number 840053, Kalispell
Investigational Site Number 840020, McHenry
Investigational Site Number 484001, Cuernavaca
Investigational Site Number 840019, Springfield
Investigational Site Number 484003, Monterrey
Investigational Site Number 250002, Strasbourg
Investigational Site Number 840003, Wichita
Investigational Site Number 840090, Fremont
Investigational Site Number 840091, Omaha
Investigational Site Number 276006, Heidelberg
Investigational Site Number 203002, Hodonín
Investigational Site Number 246005, Kuopio
Investigational Site Number 840016, Hot Springs
Investigational Site Number 840032, Searcy
Investigational Site Number 840015, Little Rock
Investigational Site Number 840124, Little Rock
Investigational Site Number 840001, Dallas
Investigational Site Number 840047, Dallas
Investigational Site Number 203007, Hranice
Investigational Site Number 840120, Hurst
Investigational Site Number 203009, Holešov
Investigational Site Number 840082, Houston
Investigational Site Number 203010, Olomouc
Investigational Site Number 840021, Austin
Investigational Site Number 840129, Austin
Investigational Site Number 840081, Austin
Investigational Site Number 203004, Krnov
Investigational Site Number 203005, Prostějov
Investigational Site Number 233002, Pärnu
Investigational Site Number 840092, Longmont
Investigational Site Number 840114, Colorado Springs
Investigational Site Number 840136, Colorado Springs
Investigational Site Number 840052, Idaho Falls
Investigational Site Number 840117, Nampa
Investigational Site Number 840010, Draper
Investigational Site Number 840060, Ogden
Investigational Site Number 840071, Phoenix
Investigational Site Number 840156, Chandler
Investigational Site Number 840070, Tempe
Investigational Site Number 840102, Glendale
Investigational Site Number 840121, Sun City
Investigational Site Number 840058, Las Vegas
Investigational Site Number 246002, Oulu
Investigational Site Number 840099, Mission Hills
Investigational Site Number 840133, Encino
Investigational Site Number 840004, La Mesa
Investigational Site Number 840059, La Jolla
Investigational Site Number 840005, San Diego
Investigational Site Number 840107, Palm Springs
Investigational Site Number 840057, Huntington Beach
Investigational Site Number 840013, Tustin
Investigational Site Number 840076, Anaheim
Investigational Site Number 840002, Walnut Creek
Investigational Site Number 840062, Greenbrae
Investigational Site Number 840083, Medford
Investigational Site Number 642007, Timișoara
Investigational Site Number 642002, Cluj-Napoca
Investigational Site Number 642003, Oradea
Investigational Site Number 642009, Târgu Mureş
Investigational Site Number 642001, Bacau
Investigational Site Number 642006, Bucharest
Investigational Site Number 642004, Iași
Investigational Site Number 642008, Iași
Investigational Site Number 840043, Brick
Investigational Site Number 840152, Toms River
Investigational Site Number 840084, Portland
Investigational Site Number 840018, Milwaukee
Investigational Site Number 124024, Beamsville
Investigational Site Number 124025, Burlington
Investigational Site Number 124023, Calgary
Investigational Site Number 124020, Calgary
Investigational Site Number 124019, Chatham
Investigational Site Number 124018, Coquitlam
Investigational Site Number 124021, Hamilton
Investigational Site Number 124014, Hamilton
Investigational Site Number 124006, Laval
Investigational Site Number 124009, London
Investigational Site Number 124008, Mississauga
Investigational Site Number 124015, Montreal
Investigational Site Number 124004, Montreal
Investigational Site Number 124005, Oshawa
Investigational Site Number 124026, Québec
Investigational Site Number 124002, Red Deer
Investigational Site Number 124017, Saint-Laurent
Investigational Site Number 124007, Thornhill
Investigational Site Number 124001, Toronto
Investigational Site Number 124011, Toronto
Investigational Site Number 124010, Victoria
Investigational Site Number 124022, Winnipeg
Investigational Site Number 203001, Břeclav
Investigational Site Number 246001, Helsinki
Investigational Site Number 276002, Riesa
Investigational Site Number 348002, Budapest
Investigational Site Number 428006, Jēkabpils
Investigational Site Number 428005, Ogre
Investigational Site Number 428002, Riga
Investigational Site Number 428001, Riga
Investigational Site Number 428004, Riga
Investigational Site Number 428003, Sigulda
Investigational Site Number 528009, Almelo
Investigational Site Number 528004, Eindhoven
Investigational Site Number 528007, Groningen
Investigational Site Number 528005, Hoogeveen
Investigational Site Number 528001, Hoorn
Investigational Site Number 528008, Leeuwarden
Investigational Site Number 528006, Utrecht
Investigational Site Number 528002, Venlo
Investigational Site Number 642005, Bucharest
Investigational Site Number 710008, Pretoria
Lead Sponsor
Sanofi
INDUSTRY