894
Participants
Start Date
January 31, 2013
Primary Completion Date
December 31, 2014
Study Completion Date
December 31, 2014
Lixisenatide (AVE0010)
Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner.
Insulin glulisine QD
Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner).
Insulin glulisine TID
Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner).
Insulin Glargine (Mandatory background drug)
Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).
Metformin (Background drug)
Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.
Investigational Site Number 348107, Budapest
Investigational Site Number 348108, Budapest
Investigational Site Number 348102, Budapest
Investigational Site Number 348101, Eger
Investigational Site Number 348106, Sátoraljaújhely
Investigational Site Number 348104, Szeged
Investigational Site Number 348103, Pápa
Investigational Site Number 348105, Zalaegerszeg
Investigational Site Number 380104, Torino
Investigational Site Number 840029, New Hyde Park
Investigational Site Number 840060, Smithtown
Investigational Site Number 484103, Mexico City
Investigational Site Number 276108, Berlin
Investigational Site Number 233103, Tallinn
Investigational Site Number 233104, Tallinn
Investigational Site Number 203105, Prague
Investigational Site Number 203108, Prague
Investigational Site Number 724105, A Coruña
Investigational Site Number 840021, Pittsburgh
Investigational Site Number 724102, Ferrol
Investigational Site Number 250104, La Rochelle
Investigational Site Number 380101, Milan
Investigational Site Number 840017, Rockville
Investigational Site Number 804105, Vinnytsia
Investigational Site Number 804102, Vinnytsia
Investigational Site Number 840016, Baltimore
Investigational Site Number 840018, Norfolk
Investigational Site Number 840015, Salem
Investigational Site Number 276103, Neumünster
Investigational Site Number 203107, Beroun
Investigational Site Number 840011, Salisbury
Investigational Site Number 724103, Málaga
Investigational Site Number 840052, Myrtle Beach
Investigational Site Number 840045, Lawrenceville
Investigational Site Number 484108, Chihuahua City
Investigational Site Number 840012, Miami
Investigational Site Number 840061, Miami
Investigational Site Number 484111, Durango
Investigational Site Number 840033, Nashville
Investigational Site Number 840032, Chattanooga
Investigational Site Number 276119, Magdeburg
Investigational Site Number 380103, Bologna
Investigational Site Number 840047, Lexington
Investigational Site Number 724104, Seville
Investigational Site Number 840056, Paducah
Investigational Site Number 276102, Dortmund
Investigational Site Number 484104, Guadalajara
Investigational Site Number 484109, Guadalajara
Investigational Site Number 484107, Guadalajara
Investigational Site Number 484105, Guadalajara
Investigational Site Number 484110, Guadalajara
Investigational Site Number 840004, Avon
Investigational Site Number 840055, Avon
Investigational Site Number 840048, Dearborn
Investigational Site Number 840026, Kalamazoo
Investigational Site Number 840025, Buckley
Investigational Site Number 840027, Des Moines
Investigational Site Number 840010, Milwaukee
Investigational Site Number 804108, Mykolaiv
Investigational Site Number 203104, Trutnov
Investigational Site Number 250101, Vandœuvre-lès-Nancy
Investigational Site Number 804104, Chernivtsi
Investigational Site Number 840028, Fargo
Investigational Site Number 840009, Evanston
Investigational Site Number 276117, Frankfurt A.M.
Investigational Site Number 840024, Chicago
Investigational Site Number 484101, Cuernavaca
Investigational Site Number 484106, Monterrey
Investigational Site Number 804110, Odesa
Investigational Site Number 276109, Saint Ingbert-Oberwürzbach
Investigational Site Number 840006, Wichita
Investigational Site Number 276115, Speyer
Investigational Site Number 276113, Heidelberg
Investigational Site Number 250103, Vénissieux
Investigational Site Number 250106, Lyon
Investigational Site Number 250107, Lyon
Investigational Site Number 804111, Zaporizhia
Investigational Site Number 840022, Marrero
Investigational Site Number 233101, Viljandimaa
Investigational Site Number 840003, Little Rock
Investigational Site Number 840007, Oklahoma City
Investigational Site Number 840001, Dallas
Investigational Site Number 250102, Paris
Investigational Site Number 250108, Bois-Guillaume
Investigational Site Number 840020, Houston
Investigational Site Number 250109, Mantes-la-Jolie
Investigational Site Number 840034, Corpus Christi
Investigational Site Number 233102, Pärnu
Investigational Site Number 380105, Napoli
Investigational Site Number 840041, Denver
Investigational Site Number 804107, Donetsk
Investigational Site Number 804103, Donetsk
Investigational Site Number 840036, Nampa
Investigational Site Number 840042, Tempe
Investigational Site Number 840043, Sun City
Investigational Site Number 840049, Las Vegas
Investigational Site Number 250105, Corbeil-Essonnes
Investigational Site Number 840057, Northridge
Investigational Site Number 840023, West Hills
Investigational Site Number 840031, La Mesa
Investigational Site Number 840002, Temecula
Investigational Site Number 840005, Mission Viejo
Investigational Site Number 840035, Santa Ana
Investigational Site Number 840037, Walnut Creek
Investigational Site Number 380102, Catania
Investigational Site Number 276112, Bad Mergentheim
Investigational Site Number 642114, Ploieşti
Investigational Site Number 642112, Piteşti
Investigational Site Number 643111, Moscow
Investigational Site Number 643107, Moscow
Investigational Site Number 643105, Moscow
Investigational Site Number 643101, Saint Petersburg
Investigational Site Number 643104, Saint Petersburg
Investigational Site Number 643109, Saint Petersburg
Investigational Site Number 643106, Saint Petersburg
Investigational Site Number 643108, Saint Petersburg
Investigational Site Number 643103, Saint Petersburg
Investigational Site Number 642116, Timișoara
Investigational Site Number 642101, Timișoara
Investigational Site Number 642115, Timișoara
Investigational Site Number 642102, Reşiţa
Investigational Site Number 642106, Deva
Investigational Site Number 642107, Hunedoara
Investigational Site Number 642108, Cluj-Napoca
Investigational Site Number 643102, Saratov
Investigational Site Number 642103, Oradea
Investigational Site Number 642104, Oradea
Investigational Site Number 643110, Penza
Investigational Site Number 642109, Târgu Mureş
Investigational Site Number 642110, Târgu Mureş
Investigational Site Number 642111, Sibiu
Investigational Site Number 642105, Bacau
Investigational Site Number 642117, Iași
Investigational Site Number 642113, Galati
Investigational Site Number 152103, Santiago
Investigational Site Number 152107, Santiago
Investigational Site Number 152101, Santiago
Investigational Site Number 152105, Santiago
Investigational Site Number 152102, Santiago
Investigational Site Number 152106, Santiago
Investigational Site Number 152108, Santiago
Investigational Site Number 840030, Staten Island
Investigational Site Number 124008, Brampton
Investigational Site Number 124015, Burlington
Investigational Site Number 124018, Chatham
Investigational Site Number 124004, Coquitlam
Investigational Site Number 124016, Etobicoke
Investigational Site Number 124014, Hamilton
Investigational Site Number 124020, Montreal
Investigational Site Number 124011, Montreal
Investigational Site Number 124017, Newmarket
Investigational Site Number 124021, Québec
Investigational Site Number 124003, Red Deer
Investigational Site Number 124012, Saint Romuald
Investigational Site Number 124002, Sherbrooke
Investigational Site Number 124001, Toronto
Investigational Site Number 124010, Toronto
Investigational Site Number 124005, Vancouver
Investigational Site Number 124006, Victoria
Investigational Site Number 124007, Winnipeg
Investigational Site Number 152109, Santiago
Investigational Site Number 203103, Jílové u Prahy
Investigational Site Number 203101, Ostrava
Investigational Site Number 203110, Police nad Metují
Investigational Site Number 203102, Prague
Investigational Site Number 276120, Dresden
Investigational Site Number 276106, Dresden
Investigational Site Number 276116, Görlitz
Investigational Site Number 276118, Leipzig
Investigational Site Number 428103, Jelgava
Investigational Site Number 428104, Ogre
Investigational Site Number 428102, Riga
Investigational Site Number 428105, Riga
Investigational Site Number 428101, Sigulda
Investigational Site Number 440104, Jonava
Investigational Site Number 440103, Kaunas
Investigational Site Number 440102, Kaunas
Investigational Site Number 440101, Kaunas
Investigational Site Number 440105, Klaipėda
Investigational Site Number 484102, México
Investigational Site Number 616101, Bialystok
Investigational Site Number 616103, Bydgoszcz
Investigational Site Number 616102, Bytom
Investigational Site Number 616106, Krakow
Investigational Site Number 616104, Krakow
Investigational Site Number 616105, Puławy
Investigational Site Number 616107, Warsaw
Investigational Site Number 826006, Ashton-under-Lyne
Investigational Site Number 826002, Birmingham
Investigational Site Number 826007, Carmarthen
Investigational Site Number 826005, Chester
Investigational Site Number 826008, Coventry
Investigational Site Number 826009, Dundee
Investigational Site Number 826001, Durham
Investigational Site Number 826011, Haddington
Investigational Site Number 826012, Leicester
Investigational Site Number 826010, Plymouth
Investigational Site Number 826004, Sheffield
Investigational Site Number 826003, St Helens
Lead Sponsor
Sanofi
INDUSTRY