Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

PHASE3CompletedINTERVENTIONAL
Enrollment

447

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Lixisenatide (AVE0010)

"Pharmaceutical form:solution~Route of administration: subcutaneous injection"

DRUG

Placebo

"Pharmaceutical form:solution~Route of administration: subcutaneous injection"

Trial Locations (51)

100029

Investigational Site Number 156001, Beijing

100034

Investigational Site Number 156033, Beijing

100088

Investigational Site Number 156006, Beijing

100700

Investigational Site Number 156005, Beijing

100730

Investigational Site Number 156004, Beijing

100853

Investigational Site Number 156002, Beijing

110022

Investigational Site Number 156032, Shenyang

116027

Investigational Site Number 156034, Dalian

130041

Investigational Site Number 156016, Changchun

136000

Investigational Site Number 156036, Siping

150001

Investigational Site Number 156017, Harbin

194354

Investigational Site Number 643003, Saint Petersburg

Investigational Site Number 643004, Saint Petersburg

195112

Investigational Site Number 643005, Saint Petersburg

200003

Investigational Site Number 156028, Shanghai

200072

Investigational Site Number 156007, Shanghai

210008

Investigational Site Number 156019, Nanjing

210011

Investigational Site Number 156020, Nanjing

215004

Investigational Site Number 156010, Suzhou

250012

Investigational Site Number 156026, Jinan

250013

Investigational Site Number 156029, Jinan

266003

Investigational Site Number 156018, Qingdao

300052

Investigational Site Number 156008, Tianjin

354200

Investigational Site Number 156035, Fuzhou

380008

Investigational Site Number 356019, Ahmedabad

410011

Investigational Site Number 156025, Changsha

411001

Investigational Site Number 356008, Pune

430030

Investigational Site Number 156027, Wuhan

440012

Investigational Site Number 356015, Nagpur

443067

Investigational Site Number 643006, Samara

500003

Investigational Site Number 356021, Secunderabad

500004

Investigational Site Number 356002, Hyderabad

500063

Investigational Site Number 356024, Hyderabad

510515

Investigational Site Number 156021, Guangzhou

530002

Investigational Site Number 356023, Visakhapatnam

560092

Investigational Site Number 356026, Bangalore

570311

Investigational Site Number 156023, Haikou

610014

Investigational Site Number 643007, Kirov

610041

Investigational Site Number 156014, Chengdu

610072

Investigational Site Number 156013, Chengdu

710032

Investigational Site Number 156011, Xi'an

710061

Investigational Site Number 156012, Xi'an

751005

Investigational Site Number 356017, Bhubaneswar

050051

Investigational Site Number 156009, Shijiazhuang

202 002

Investigational Site Number 356018, Aligarh

705-703

Investigational Site Number 410003, Daegu

411-706

Investigational Site Number 410007, Goyang

130-872

Investigational Site Number 410006, Seoul

136-705

Investigational Site Number 410001, Seoul

139-872

Investigational Site Number 410005, Seoul

220-701

Investigational Site Number 410002, Wŏnju

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT01632163 - Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin | Biotech Hunter | Biotech Hunter