736
Participants
Start Date
January 31, 2014
Primary Completion Date
July 31, 2015
Study Completion Date
July 31, 2015
Insulin glargine/lixisenatide (HOE901/AVE0010)
"Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization.~Dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg."
Insulin glargine (HOE901)
"Insulin glargine was self-administered QD by SC injection at approximately the same time every day.~After screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L)."
Metformin (Background Drug)
Pharmaceutical form: Tablet; Route of administration: Oral administration
Investigational Site Number 348503, Budapest
Investigational Site Number 348501, Budapest
Investigational Site Number 348505, Budapest
Investigational Site Number 208505, København S
Investigational Site Number 208501, København NV
Investigational Site Number 036504, Parkville
Investigational Site Number 036501, Heidelberg
Investigational Site Number 036505, Box Hill
Investigational Site Number 703511, Ľubochňa
Investigational Site Number 348502, Debrecen
Investigational Site Number 208502, Kolding
Investigational Site Number 348506, Kaposvár
Investigational Site Number 208503, Aarhus C
Investigational Site Number 348504, Pápa
Investigational Site Number 208509, Horsens
Investigational Site Number 208504, Viborg
Investigational Site Number 724505, Cáceres
Investigational Site Number 233503, Tallinn
Investigational Site Number 840531, New Hyde Park
Investigational Site Number 840583, Jamaica
Investigational Site Number 752505, Stockholm
Investigational Site Number 203511, Prague
Investigational Site Number 724508, A Coruña
Investigational Site Number 203508, Prague
Investigational Site Number 724503, Ferrol
Investigational Site Number 840551, Smithfield
Investigational Site Number 752502, Vällingby
Investigational Site Number 840584, Tipton
Investigational Site Number 203509, Prague
Investigational Site Number 840610, Philadelphia
Investigational Site Number 840549, Wilmington
Investigational Site Number 840522, Rockville
Investigational Site Number 804502, Vinnytsia
Investigational Site Number 804508, Vinnytsia
Investigational Site Number 840520, Baltimore
Investigational Site Number 840560, Baltimore
Investigational Site Number 840606, Richmond
Investigational Site Number 840504, Chesapeake
Investigational Site Number 840561, Norfolk
Investigational Site Number 840625, Norfolk
Investigational Site Number 840608, Salem
Investigational Site Number 840515, Winston-Salem
Investigational Site Number 840541, Durham
Investigational Site Number 840604, Greenville
Investigational Site Number 840592, Salisbury
Investigational Site Number 840535, Wilmington
Investigational Site Number 840513, Morehead City
Investigational Site Number 840540, Hickory
Investigational Site Number 840622, Charleston
Investigational Site Number 840501, Lawrenceville
Investigational Site Number 840525, Roswell
Investigational Site Number 840594, Atlanta
Investigational Site Number 840614, Columbus
Investigational Site Number 840602, Ocala
Investigational Site Number 840521, New Port Richey
Investigational Site Number 840534, Palm Harbor
Investigational Site Number 840538, Ocoee
Investigational Site Number 203502, Cheb
Investigational Site Number 840607, Birmingham
Investigational Site Number 484508, Celaya
Investigational Site Number 724507, Segovia
Investigational Site Number 840516, Louisville
Investigational Site Number 484507, Pachuca
Investigational Site Number 840579, Columbus
Investigational Site Number 840503, Maumee
Investigational Site Number 484503, Guadalajara
Investigational Site Number 484504, Guadalajara
Investigational Site Number 752506, Stenungssund
Investigational Site Number 484506, Guadalajara
Investigational Site Number 840524, Dayton
Investigational Site Number 724502, Valencia
Investigational Site Number 840543, Avon
Investigational Site Number 840563, Indianapolis
Investigational Site Number 840507, Indianapolis
Investigational Site Number 724506, Alzira
Investigational Site Number 840565, Evansville
Investigational Site Number 840585, Evansville
Investigational Site Number 840615, Evansville
Investigational Site Number 840505, Dearborn
Investigational Site Number 440501, Kaunas
Investigational Site Number 840575, Flint
Investigational Site Number 440503, Kaunas
Investigational Site Number 233501, Tartu
Investigational Site Number 840564, Minneapolis
Investigational Site Number 840611, Rapid City
Investigational Site Number 804501, Chernivtsi
Investigational Site Number 840558, Butte
Investigational Site Number 840580, Arlington Heights
Investigational Site Number 840519, Chicago
Investigational Site Number 840612, Chicago
Investigational Site Number 484501, Cuernavaca
Investigational Site Number 840556, Springfield
Investigational Site Number 840506, Omaha
Investigational Site Number 484505, Puebla City
Investigational Site Number 840517, Little Rock
Investigational Site Number 840537, Little Rock
Investigational Site Number 840601, Dallas
Investigational Site Number 840586, Dallas
Investigational Site Number 840547, Dallas
Investigational Site Number 840530, Dallas
Investigational Site Number 840545, Dallas
Investigational Site Number 203504, Hranice
Investigational Site Number 840514, Hurst
Investigational Site Number 840617, N Richland Hill
Investigational Site Number 840544, Houston
Investigational Site Number 203503, Olomouc
Investigational Site Number 840502, Corpus Christi
Investigational Site Number 840554, Edinburg
Investigational Site Number 840553, Austin
Investigational Site Number 840598, Austin
Investigational Site Number 804513, Lviv
Investigational Site Number 840605, Amarillo
Investigational Site Number 203507, Krnov
Investigational Site Number 752504, Rättvik
Investigational Site Number 203505, Prostějov
Investigational Site Number 233502, Pärnu
Investigational Site Number 840582, Aurora
Investigational Site Number 840509, Denver
Investigational Site Number 840588, Idaho Falls
Investigational Site Number 840512, Draper
Investigational Site Number 840597, Orem
Investigational Site Number 840590, Salt Lake City
Investigational Site Number 840591, Murray
Investigational Site Number 840526, Ogden
Investigational Site Number 703505, Bratislava
Investigational Site Number 840570, Sun City
Investigational Site Number 840577, Tucson
Investigational Site Number 840576, Albuquerque
Investigational Site Number 840600, Henderson
Investigational Site Number 840532, Las Vegas
Investigational Site Number 840599, Las Vegas
Investigational Site Number 840626, Los Angeles
Investigational Site Number 840581, Los Angeles
Investigational Site Number 840568, Bell Gardens
Investigational Site Number 840511, Northridge
Investigational Site Number 840572, West Hills
Investigational Site Number 840569, Tarzana
Investigational Site Number 703504, Nové Mesto nad Váhom
Investigational Site Number 703513, Trnava
Investigational Site Number 840550, Chino
Investigational Site Number 840529, Chula Vista
Investigational Site Number 840573, Palm Springs
Investigational Site Number 840621, Mission Viejo
Investigational Site Number 840567, Santa Ana
Investigational Site Number 840623, Corona
Investigational Site Number 840559, Port Hueneme
Investigational Site Number 840578, Lancaster
Investigational Site Number 840566, Fresno
Investigational Site Number 703509, Nové Zámky
Investigational Site Number 840536, San Ramon
Investigational Site Number 840552, Greenbrae
Investigational Site Number 840618, Eugene
Investigational Site Number 840571, Federal Way
Investigational Site Number 840593, Spokane
Investigational Site Number 643512, Moscow
Investigational Site Number 643511, Arkhangelsk
Investigational Site Number 643501, Saint Petersburg
Investigational Site Number 643506, Saint Petersburg
Investigational Site Number 643503, Saint Petersburg
Investigational Site Number 643504, Saint Petersburg
Investigational Site Number 643505, Saint Petersburg
Investigational Site Number 643502, Saint Petersburg
Investigational Site Number 642504, Timișoara
Investigational Site Number 642503, Timișoara
Investigational Site Number 642506, Hunedoara
Investigational Site Number 643509, Voronezh
Investigational Site Number 643507, Saratov
Investigational Site Number 643514, Saratov
Investigational Site Number 642502, Oradea
Investigational Site Number 643508, Penza
Investigational Site Number 643513, Samara
Investigational Site Number 642507, Brasov
Investigational Site Number 642501, Târgu Mureş
Investigational Site Number 642511, Sibiu
Investigational Site Number 642505, Iași
Investigational Site Number 152513, Temuco
Investigational Site Number 152511, Puerto Varas
Investigational Site Number 152502, Santiago
Investigational Site Number 152501, Santiago
Investigational Site Number 152514, Santiago
Investigational Site Number 152503, Santiago
Investigational Site Number 840562, Tempe
Investigational Site Number 152507, Santiago
Investigational Site Number 152509, Talagante
Investigational Site Number 152504, Viña del Mar
Investigational Site Number 804511, Kyiv
Investigational Site Number 840510, Miami
Investigational Site Number 840595, Lewiston
Investigational Site Number 840539, Nashua
Investigational Site Number 840557, Syracuse
Investigational Site Number 840613, Burlington
Investigational Site Number 840609, Tacoma
Investigational Site Number 840546, Milwaukee
Investigational Site Number 124504, Beamsville
Investigational Site Number 124512, Brampton
Investigational Site Number 124502, Guelph
Investigational Site Number 124507, Kelowna
Investigational Site Number 124505, Montreal
Investigational Site Number 124511, Oakville
Investigational Site Number 124509, Saint Romuald
Investigational Site Number 124503, Toronto
Investigational Site Number 124510, Toronto
Investigational Site Number 124501, Vancouver
Investigational Site Number 124508, Victoria
Investigational Site Number 203506, Liberec
Investigational Site Number 203514, Pilsen
Investigational Site Number 203515, Pilsen
Investigational Site Number 440505, Kėdainiai
Investigational Site Number 440504, Klaipėda
Investigational Site Number 440502, Vilnius
Investigational Site Number 484509, México
Investigational Site Number 528505, Almere Stad
Investigational Site Number 616502, Bialystok
Investigational Site Number 616505, Krakow
Investigational Site Number 616506, Krakow
Investigational Site Number 616507, Płock
Investigational Site Number 616504, Szczecin
Investigational Site Number 616503, Warsaw
Investigational Site Number 616501, Warsaw
Investigational Site Number 642510, Bucharest
Investigational Site Number 642508, Bucharest
Investigational Site Number 642509, Bucharest
Investigational Site Number 703507, Bytča
Investigational Site Number 703502, Košice
Investigational Site Number 703512, Košice
Investigational Site Number 703510, Košice
Investigational Site Number 703508, Moldava nad Bodvou
Investigational Site Number 703501, Žilina
Investigational Site Number 724509, Alicante
Investigational Site Number 724504, Barcelona
Investigational Site Number 724510, Barcelona
Investigational Site Number 724501, Sabadell
Investigational Site Number 752501, Ljungby
Investigational Site Number 752503, Malmo
Investigational Site Number 804510, Kyiv
Investigational Site Number 804507, Kyiv
Lead Sponsor
Sanofi
INDUSTRY