Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

PHASE3CompletedINTERVENTIONAL
Enrollment

321

Participants

Timeline

Start Date

May 9, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Insulin glargine/Lixisenatide (HOE901/AVE0010)

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

DRUG

Lixisenatide (AVE0010)

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

DRUG

Oral anti-diabetic drugs

"Pharmaceutical form: tablet~Route of administration: Oral"

Trial Locations (61)

Unknown

Investigational Site Number 392002, Adachi-Ku

Investigational Site Number 392009, Arakawa-Ku

Investigational Site Number 392025, Atsugi-Shi

Investigational Site Number 392060, Bunkyō City

Investigational Site Number 392024, Chiba

Investigational Site Number 392011, Chigasaki-Shi

Investigational Site Number 392013, Chiyoda-Ku

Investigational Site Number 392052, Chiyoda-Ku

Investigational Site Number 392003, Chūōku

Investigational Site Number 392017, Chūōku

Investigational Site Number 392008, Fujimi-Shi

Investigational Site Number 392054, Fukuoka

Investigational Site Number 392094, Fukuoka

Investigational Site Number 392059, Hachioji-Shi

Investigational Site Number 392083, Hakodate-Shi

Investigational Site Number 392048, Hamamatsu

Investigational Site Number 392079, Hiki-Gun

Investigational Site Number 392057, Iruma-Shi

Investigational Site Number 392022, Ise-Shi

Investigational Site Number 392023, Isehara-Shi

Investigational Site Number 392020, Izumisano

Investigational Site Number 392066, Kashiwa-Shi

Investigational Site Number 392006, Kasugai-Shi

Investigational Site Number 392053, Kawagoe-Shi

Investigational Site Number 392065, Kawagoe-Shi

Investigational Site Number 392007, Kawaguchi-Shi

Investigational Site Number 392062, Kawaguchi-Shi

Investigational Site Number 392077, Kawasaki-Shi

Investigational Site Number 392082, Kawasaki-Shi

Investigational Site Number 392031, Kitakyushu-Shi

Investigational Site Number 392041, Kitakyusyu-Shi

Investigational Site Number 392068, Kitakyusyu-Shi

Investigational Site Number 392044, Koga-Shi

Investigational Site Number 392001, Koriyama-Shi

Investigational Site Number 392032, Kurume-Shi

Investigational Site Number 392088, Maebashi

Investigational Site Number 392014, Mitaka-Shi

Investigational Site Number 392042, Mito

Investigational Site Number 392078, Mito

Investigational Site Number 392026, Nagoya

Investigational Site Number 392080, Okayama

Investigational Site Number 392040, Oyama-Shi

Investigational Site Number 392038, Sagamihara-Shi

Investigational Site Number 392069, Saijo-Shi

Investigational Site Number 392030, Saitama-Shi

Investigational Site Number 392047, Sapporo

Investigational Site Number 392015, Satsumasendai-Shi

Investigational Site Number 392004, Sendai

Investigational Site Number 392034, Shimotsuke-Shi

Investigational Site Number 392037, Shizuoka

Investigational Site Number 392081, Shizuoka

Investigational Site Number 392019, Shobara-Shi

Investigational Site Number 392018, Shunan-Shi

Investigational Site Number 392027, Suita-Shi

Investigational Site Number 392056, Taito-Ku

Investigational Site Number 392051, Takatsuki-Shi

Investigational Site Number 392061, Tokorozawa-Shi

Investigational Site Number 392029, Toyonaka-Shi

Investigational Site Number 392093, Ube-Shi

Investigational Site Number 392067, Yatsushiro-Shi

Investigational Site Number 392035, Zentsuji-Shi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY