Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

PHASE3CompletedINTERVENTIONAL
Enrollment

513

Participants

Timeline

Start Date

May 17, 2016

Primary Completion Date

October 4, 2018

Study Completion Date

October 4, 2018

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Insulin glargine/Lixisenatide (HOE901/AVE0010)

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

DRUG

Insulin glargine U100 (HOE901)

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

DRUG

Metformin

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

Trial Locations (122)

Unknown

Investigational Site Number 392002, Adachi-Ku

Investigational Site Number 392132, Annaka-Shi

Investigational Site Number 392009, Arakawa-Ku

Investigational Site Number 392152, Asahikawa-Shi

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 392008, Fujimi-Shi

Investigational Site Number 392143, Fujisawa-Shi

Investigational Site Number 392094, Fukuoka

Investigational Site Number 392147, Fukuoka

Investigational Site Number 392100, Gifu

Investigational Site Number 392059, Hachioji-Shi

Investigational Site Number 392048, Hamamatsu

Investigational Site Number 392102, Hamamatsu

Investigational Site Number 392123, Higashiosaka-Shi

Investigational Site Number 392135, Higashiosaka-Shi

Investigational Site Number 392079, Hiki-Gun

Investigational Site Number 392141, Himeji-Shi

Investigational Site Number 392057, Iruma-Shi

Investigational Site Number 392022, Ise-Shi

Investigational Site Number 392020, Izumisano

Investigational Site Number 392036, Kamakura-Shi

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 392149, 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 392090, Kawaguchi-Shi

Investigational Site Number 392077, Kawasaki-Shi

Investigational Site Number 392082, Kawasaki-Shi

Investigational Site Number 392142, Kawasaki-Shi

Investigational Site Number 392010, Kisarazu-Shi

Investigational Site Number 392016, Kisarazu-Shi

Investigational Site Number 392031, Kitakyushu-Shi

Investigational Site Number 392068, Kitakyushu-Shi

Investigational Site Number 392041, Kitakyusyu-Shi

Investigational Site Number 392086, Kobe

Investigational Site Number 392044, Koga-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 392116, Kumamoto

Investigational Site Number 392099, Kushiro

Investigational Site Number 392049, Kyoto

Investigational Site Number 392107, Kyoto

Investigational Site Number 392088, Maebashi

Investigational Site Number 392158, Maebashi

Investigational Site Number 392121, Matsuyama

Investigational Site Number 392122, Minatoku

Investigational Site Number 392076, Misato-Shi

Investigational Site Number 392014, Mitaka-Shi

Investigational Site Number 392042, Mito

Investigational Site Number 392043, Mito

Investigational Site Number 392078, Mito

Investigational Site Number 392046, Miyazaki

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 392137, Nagoya

Investigational Site Number 392140, Nagoya

Investigational Site Number 392154, Naka

Investigational Site Number 392050, Niihama-Shi

Investigational Site Number 392159, Obihiro-Shi

Investigational Site Number 392145, Ogaki-Shi

Investigational Site Number 392005, Okawa-Shi

Investigational Site Number 392071, Okayama

Investigational Site Number 392080, Okayama

Investigational Site Number 392095, Onga-Gun

Investigational Site Number 392105, Osaka

Investigational Site Number 392117, Osaka

Investigational Site Number 392144, Osaka

Investigational Site Number 392125, Osaki-Shi

Investigational Site Number 392157, Ota-Shi

Investigational Site Number 392040, Oyama-Shi

Investigational Site Number 392153, Ōita

Investigational Site Number 392120, Ōta-ku

Investigational Site Number 392038, Sagamihara-Shi

Investigational Site Number 392069, Saijo-Shi

Investigational Site Number 392030, Saitama-Shi

Investigational Site Number 392058, Saitama-Shi

Investigational Site Number 392074, Sanda-Shi

Investigational Site Number 392047, Sapporo

Investigational Site Number 392106, Sapporo

Investigational Site Number 392097, Sasebo-Shi

Investigational Site Number 392015, Satsumasendai-Shi

Investigational Site Number 392004, Sendai

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 392104, Shiogama-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 392156, Takatsuki-Shi

Investigational Site Number 392061, Tokorozawa-Shi

Investigational Site Number 392111, Tomakomai-Shi

Investigational Site Number 392073, Tsu

Investigational Site Number 392063, Ube-Shi

Investigational Site Number 392124, Ushiku-Shi

Investigational Site Number 392067, Yatsushiro-Shi

Investigational Site Number 392085, Yokohama

Investigational Site Number 392126, Yokohama

Investigational Site Number 392035, Zentsuji-Shi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY