391
Participants
Start Date
July 31, 2010
Primary Completion Date
December 31, 2011
Study Completion Date
December 31, 2011
Lixisenatide (AVE0010)
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Placebo
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector
Metformin
Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24.
Sulfonylurea
Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c \<8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c \>=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.
Investigational Site Number 764002, Bangkok
Investigational Site Number 458001, Kelantan
Investigational Site Number 156031, Haikou
Investigational Site Number 458003, Kuala Lumpur
Investigational Site Number 458002, Putrajaya
Investigational Site Number 156011, Beijing
Investigational Site Number 156012, Beijing
Investigational Site Number 156019, Beijing
Investigational Site Number 156002, Beijing
Investigational Site Number 156003, Beijing
Investigational Site Number 156009, Beijing
Investigational Site Number 156001, Beijing
Investigational Site Number 156020, Shenyang
Investigational Site Number 156010, Dalian
Investigational Site Number 156036, Changchun
Investigational Site Number 156014, Harbin
Investigational Site Number 156007, Shanghai
Investigational Site Number 156030, Shanghai
Investigational Site Number 156035, Suzhou
Investigational Site Number 156029, Hefei
Investigational Site Number 156013, Qingdao
Investigational Site Number 156037, Tianjin
Investigational Site Number 156016, Changsha
Investigational Site Number 156015, Changsha
Investigational Site Number 156004, Guangzhou
Investigational Site Number 156008, Guangzhou
Investigational Site Number 156025, Guangzhou
Investigational Site Number 156006, Chengdu
Investigational Site Number 156032, Chengdu
Investigational Site Number 156022, Xi'an
Investigational Site Number 156023, Xi'an
Investigational Site Number 156033, Taiyuan
Investigational Site Number 344001, Hong Kong
Investigational Site Number 344003, Hong Kong
Investigational Site Number 344002, Shatin, Nt
Lead Sponsor
Sanofi
INDUSTRY