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

PHASE3CompletedINTERVENTIONAL
Enrollment

521

Participants

Timeline

Start Date

May 23, 2016

Primary Completion Date

March 12, 2018

Study Completion Date

March 12, 2018

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Insulin glargine/lixisenatide (HOE901/AVE0010)

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

DRUG

Insulin glargine (HOE901)

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

DRUG

Oral anti-diabetic drugs

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

Trial Locations (113)

Unknown

Investigational Site Number 392002, Adachi-Ku

Investigational Site Number 392132, Annaka-Shi

Investigational Site Number 392009, Arakawa-Ku

Investigational Site Number 392025, Atsugi-Shi

Investigational Site Number 392024, Chiba

Investigational Site Number 392151, 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 392055, Chūōku

Investigational Site Number 392155, Chūōku

Investigational Site Number 392008, Fujimi-Shi

Investigational Site Number 392143, Fujisawa-Shi

Investigational Site Number 392054, Fukuoka

Investigational Site Number 392094, Fukuoka

Investigational Site Number 392147, Fukuoka

Investigational Site Number 392100, Gifu

Investigational Site Number 392059, Hachioji-Shi

Investigational Site Number 392083, Hakodate-Shi

Investigational Site Number 392048, Hamamatsu

Investigational Site Number 392102, Hamamatsu

Investigational Site Number 392079, Hiki-Gun

Investigational Site Number 392112, Hirosaki-Shi

Investigational Site Number 392109, Hofu-Shi

Investigational Site Number 392057, Iruma-Shi

Investigational Site Number 392022, Ise-Shi

Investigational Site Number 392020, Izumisano

Investigational Site Number 392139, Kagoshima

Investigational Site Number 392136, Kamogawa-Shi

Investigational Site Number 392066, Kashiwa-Shi

Investigational Site Number 392045, Kashiwara-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 392091, Kawasaki-Shi

Investigational Site Number 392142, Kawasaki-Shi

Investigational Site Number 392133, Kitaazumi-Gun

Investigational Site Number 392129, Kitakyushu-Shi

Investigational Site Number 392041, Kitakyusyu-Shi

Investigational Site Number 392068, Kitakyusyu-Shi

Investigational Site Number 392114, Kitamoto-Shi

Investigational Site Number 392086, Kobe

Investigational Site Number 392044, Koga-Shi

Investigational Site Number 392119, Kokubunji-Shi

Investigational Site Number 392001, Koriyama-Shi

Investigational Site Number 392028, Kumamoto

Investigational Site Number 392092, Kumamoto

Investigational Site Number 392108, Kumamoto

Investigational Site Number 392075, Kure-Shi

Investigational Site Number 392032, Kurume-Shi

Investigational Site Number 392118, Kushiro

Investigational Site Number 392107, Kyoto

Investigational Site Number 392088, Maebashi

Investigational Site Number 392113, Matsumoto-Shi

Investigational Site Number 392122, Minatoku

Investigational Site Number 392076, Misato-Shi

Investigational Site Number 392042, Mito

Investigational Site Number 392078, Mito

Investigational Site Number 392148, Nagano

Investigational Site Number 392026, Nagoya

Investigational Site Number 392101, Nagoya

Investigational Site Number 392128, Nagoya

Investigational Site Number 392131, Nagoya

Investigational Site Number 392134, Nagoya

Investigational Site Number 392154, Naka

Investigational Site Number 392127, Niigata

Investigational Site Number 392050, Niihama-Shi

Investigational Site Number 392115, Ogawa-Machi, Hikigun

Investigational Site Number 392071, Okayama

Investigational Site Number 392095, Onga-Gun

Investigational Site Number 392117, Osaka

Investigational Site Number 392144, Osaka

Investigational Site Number 392040, Oyama-Shi

Investigational Site Number 392084, Saga

Investigational Site Number 392069, Saijo-Shi

Investigational Site Number 392030, Saitama-Shi

Investigational Site Number 392074, Sanda-Shi

Investigational Site Number 392047, Sapporo

Investigational Site Number 392089, Sapporo

Investigational Site Number 392150, Sapporo

Investigational Site Number 392097, Sasebo-Shi

Investigational Site Number 392004, Sendai

Investigational Site Number 392103, Sendai

Investigational Site Number 392070, Shimonoseki-Shi

Investigational Site Number 392034, Shimotsuke-Shi

Investigational Site Number 392110, Shinagawa-Ku

Investigational Site Number 392021, Shinjuku-Ku

Investigational Site Number 392098, Shinjuku-Ku

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 392146, Takamatsu

Investigational Site Number 392051, Takatsuki-Shi

Investigational Site Number 392061, Tokorozawa-Shi

Investigational Site Number 392111, Tomakomai-Shi

Investigational Site Number 392029, Toyonaka-Shi

Investigational Site Number 392073, Tsu

Investigational Site Number 392063, Ube-Shi

Investigational Site Number 392093, Ube-Shi

Investigational Site Number 392039, Yamato-Shi

Investigational Site Number 392067, Yatsushiro-Shi

Investigational Site Number 392012, Yokohama

Investigational Site Number 392126, Yokohama

Investigational Site Number 392035, Zentsuji-Shi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY