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Clinical Trial Details

Trial ID: L3984
Source ID: NCT01368081
Associated Drug: Metformin
Title: Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01368081/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin|DRUG: BI 10773|DRUG: Placebo (low dose)|DRUG: BI 10773|DRUG: Placebo (high dose)
Outcome Measures: Primary: Number of Patients With Drug Related Adverse Events, Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days, After the first drug intake until 7 days after the last treatment administration, up to 383 days | Secondary: Change From Baseline in HbA1c, Change from baseline in HbA1c after 52 weeks of treatment, Baseline and 52 weeks | Other: Confirmed Hypoglycaemic Adverse Events, Number of patients with confirmed hypoglycaemic adverse events, After the first drug intake until 7 days after the last treatment administration, up to 383 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1162
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2011-05
Completion Date: 2013-04
Results First Posted: 2014-06-17
Last Update Posted: 2014-06-17
Locations: 1245.52.023 Boehringer Ingelheim Investigational Site, Adachi-ku, Tokyo, Japan|1245.52.048 Boehringer Ingelheim Investigational Site, Aki-gun, Hiroshima, Japan|1245.52.012 Boehringer Ingelheim Investigational Site, Annaka, Gunma, Japan|1245.52.087 Boehringer Ingelheim Investigational Site, Atami, Shizuoka, Japan|1245.52.008 Boehringer Ingelheim Investigational Site, Beppu, Oita, Japan|1245.52.073 Boehringer Ingelheim Investigational Site, Chiyoda-ku, Tokyo, Japan|1245.52.002 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1245.52.020 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1245.52.021 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1245.52.031 Boehringer Ingelheim Investigational Site, Fujisawa, Kanagawa, Japan|1245.52.077 Boehringer Ingelheim Investigational Site, Fukuoka, Fukuoka, Japan|1245.52.086 Boehringer Ingelheim Investigational Site, Hadano, Kanagawa, Japan|1245.52.037 Boehringer Ingelheim Investigational Site, Hamamatsu, Shizuoka, Japan|1245.52.046 Boehringer Ingelheim Investigational Site, Himeji, Hyogo, Japan|1245.52.047 Boehringer Ingelheim Investigational Site, Hiroshima, Hiroshima, Japan|1245.52.051 Boehringer Ingelheim Investigational Site, Imabari, Ehime, Japan|1245.52.016 Boehringer Ingelheim Investigational Site, Iruma,Saitama, Japan|1245.52.033 Boehringer Ingelheim Investigational Site, Isehara, Kanagawa, Japan|1245.52.011 Boehringer Ingelheim Investigational Site, Isesaki, Gunma, Japan|1245.52.045 Boehringer Ingelheim Investigational Site, Izumisano,Osaka, Japan|1245.52.088 Boehringer Ingelheim Investigational Site, Kamakura, Kanagawa, Japan|1245.52.072 Boehringer Ingelheim Investigational Site, Kamakura,Kanagawa, Japan|1245.52.034 Boehringer Ingelheim Investigational Site, Kanazawa, Ishikawa, Japan|1245.52.058 Boehringer Ingelheim Investigational Site, Kanoya, Kagoshima, Japan|1245.52.019 Boehringer Ingelheim Investigational Site, Kashiwa, Chiba, Japan|1245.52.039 Boehringer Ingelheim Investigational Site, Kasugai, Aichi, Japan|1245.52.027 Boehringer Ingelheim Investigational Site, Kawasaki, Kanagawa, Japan|1245.52.018 Boehringer Ingelheim Investigational Site, Kita-adachi-gun, Saitama, Japan|1245.52.022 Boehringer Ingelheim Investigational Site, Kita-ku, Tokyo, Japan|1245.52.052 Boehringer Ingelheim Investigational Site, Kitakyushu, Fukuoka, Japan|1245.52.076 Boehringer Ingelheim Investigational Site, Kobe, Hyogo, Japan|1245.52.026 Boehringer Ingelheim Investigational Site, Kodaira, Tokyo, Japan|1245.52.069 Boehringer Ingelheim Investigational Site, Koriyama, Fukushima, Japan|1245.52.071 Boehringer Ingelheim Investigational Site, Koriyama, Fukushima, Japan|1245.52.014 Boehringer Ingelheim Investigational Site, Koshigaya, Saitama, Japan|1245.52.074 Boehringer Ingelheim Investigational Site, Kuki, Saitama, Japan|1245.52.055 Boehringer Ingelheim Investigational Site, Kumamoto, Kumamoto, Japan|1245.52.049 Boehringer Ingelheim Investigational Site, Kure, Hiroshima, Japan|1245.52.040 Boehringer Ingelheim Investigational Site, Kyoto, Kyoto, Japan|1245.52.010 Boehringer Ingelheim Investigational Site, Maebashi, Gunma, Japan|1245.52.080 Boehringer Ingelheim Investigational Site, Maebashi, Gunma, Japan|1245.52.050 Boehringer Ingelheim Investigational Site, Matsuyama, Ehime, Japan|1245.52.075 Boehringer Ingelheim Investigational Site, Meguro-ku, Tokyo, Japan|1245.52.056 Boehringer Ingelheim Investigational Site, Miyazaki, Miyazaki, Japan|1245.52.057 Boehringer Ingelheim Investigational Site, Miyazaki, Miyazaki, Japan|1245.52.079 Boehringer Ingelheim Investigational Site, Morioka, Iwate, Japan|1245.52.003 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1245.52.004 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1245.52.005 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1245.52.038 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan|1245.52.059 Boehringer Ingelheim Investigational Site, Naha, Okinawa, Japan|1245.52.066 Boehringer Ingelheim Investigational Site, Naha, Okinawa, Japan|1245.52.065 Boehringer Ingelheim Investigational Site, Nanjyo, Okinawa, Japan|1245.52.007 Boehringer Ingelheim Investigational Site, Oita, Oita, Japan|1245.52.053 Boehringer Ingelheim Investigational Site, Okawa, Fukuoka, Japan|1245.52.068 Boehringer Ingelheim Investigational Site, Okinawa, Okinawa, Japan|1245.52.042 Boehringer Ingelheim Investigational Site, Osaka,Osaka, Japan|1245.52.089 Boehringer Ingelheim Investigational Site, Osaki, Miyagi, Japan|1245.52.024 Boehringer Ingelheim Investigational Site, Ota-ku, Tokyo, Japan|1245.52.054 Boehringer Ingelheim Investigational Site, Saga, Saga, Japan|1245.52.032 Boehringer Ingelheim Investigational Site, Sagamihara, Kanagawa, Japan|1245.52.085 Boehringer Ingelheim Investigational Site, Sagamihara, Kanagawa, Japan|1245.52.013 Boehringer Ingelheim Investigational Site, Saitama, Saitama, Japan|1245.52.015 Boehringer Ingelheim Investigational Site, Sakado, Saitama, Japan|1245.52.044 Boehringer Ingelheim Investigational Site, Sakai, Osaka, Japan|1245.52.035 Boehringer Ingelheim Investigational Site, Saku, Nagano, Japan|1245.52.009 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1245.52.025 Boehringer Ingelheim Investigational Site, Setagaya-ku, Tokyo, Japan|1245.52.063 Boehringer Ingelheim Investigational Site, Shimajiri-gun, Okinawa, Japan|1245.52.064 Boehringer Ingelheim Investigational Site, Shimajiri-gun, Okinawa, Japan|1245.52.001 Boehringer Ingelheim Investigational Site, Shinjuku-ku. Tokyo, Japan|1245.52.036 Boehringer Ingelheim Investigational Site, Shizuoka, Shizuoka, Japan|1245.52.006 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan|1245.52.043 Boehringer Ingelheim Investigational Site, Takatsuki, Osaka, Japan|1245.52.017 Boehringer Ingelheim Investigational Site, Tokorozawa, Saitama, Japan|1245.52.070 Boehringer Ingelheim Investigational Site, Tokorozawa, Saitama, Japan|1245.52.061 Boehringer Ingelheim Investigational Site, Tomigusuku, Okinawa, Japan|1245.52.062 Boehringer Ingelheim Investigational Site, Tomigusuku, Okinawa, Japan|1245.52.041 Boehringer Ingelheim Investigational Site, Uji, Kyoto, Japan|1245.52.067 Boehringer Ingelheim Investigational Site, Uruma, Okinawa, Japan|1245.52.028 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan|1245.52.029 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan|1245.52.030 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan|1245.52.081 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan|1245.52.082 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan|1245.52.083 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan|1245.52.084 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan
URL: https://clinicaltrials.gov/show/NCT01368081

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details