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Clinical Trial Details

Trial ID: L4487
Source ID: NCT01193218
Associated Drug: Placebo (Low Dose)
Title: Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01193218/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo (low dose)|DRUG: Placebo (low dose)|DRUG: Placebo (mid dose)|DRUG: Placebo (high dose)|DRUG: BI 10773|DRUG: Placebo (mid dose)|DRUG: Placebo (high dose)|DRUG: Placebo (high dose)|DRUG: BI 10773|DRUG: BI 10773|DRUG: Placebo (mid dose)|DRUG: Placebo (high dose)|DRUG: Placebo (low dose)|DRUG: Placebo (low dose)|DRUG: BI 10773|DRUG: Placebo (mid dose)
Outcome Measures: Primary: Change From Baseline in HbA1c After 12 Weeks of Treatment., The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment., baseline and 12 weeks | Secondary: Occurrence of Treat to Target Efficacy Response, Occurrence of treat to target efficacy response, that is an HbA1c of \<7.0% after 12 weeks of treatment, baseline and 12 weeks|Change From Baseline in FPG, Change from baseline in FPG after 12 weeks of treatment, baseline and 12 weeks | Other: Confirmed Hypoglycaemic Adverse Events, Number of patients with confirmed hypoglycaemic adverse events, between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 547
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2010-09
Completion Date: 2012-06
Results First Posted: 2014-06-17
Last Update Posted: 2014-06-17
Locations: 1245.38.016 Boehringer Ingelheim Investigational Site, Chiyoda-ku, Tokyo, Japan|1245.38.001 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1245.38.003 Boehringer Ingelheim Investigational Site, Chuo-ku, Tokyo, Japan|1245.38.002 Boehringer Ingelheim Investigational Site, Hachioji, Tokyo, Japan|1245.38.010 Boehringer Ingelheim Investigational Site, Hanamaki, Iwate, Japan|1245.38.005 Boehringer Ingelheim Investigational Site, Kamakura, Kanagawa, Japan|1245.38.020 Boehringer Ingelheim Investigational Site, Kanazawa, Ishikawa, Japan|1245.38.013 Boehringer Ingelheim Investigational Site, Kashiwa, Chiba, Japan|1245.38.019 Boehringer Ingelheim Investigational Site, Katsushika-ku, Tokyo, Japan|1245.38.021 Boehringer Ingelheim Investigational Site, Kyoto, Kyoto, Japan|1245.38.024 Boehringer Ingelheim Investigational Site, Matsuyama, Ehime, Japan|1245.38.004 Boehringer Ingelheim Investigational Site, Minato-ku, Tokyo, Japan|1245.38.011 Boehringer Ingelheim Investigational Site, Moriya, Ibaraki, Japan|1245.38.030 Boehringer Ingelheim Investigational Site, Naha, Okinawa, Japan|1245.38.032 Boehringer Ingelheim Investigational Site, Okawa, Fukuoka, Japan|1245.38.031 Boehringer Ingelheim Investigational Site, Okinawa, Okinawa, Japan|1245.38.025 Boehringer Ingelheim Investigational Site, Saga, Saga, Japan|1245.38.014 Boehringer Ingelheim Investigational Site, Saitama, Saitama, Japan|1245.38.006 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1245.38.007 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1245.38.008 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1245.38.009 Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido, Japan|1245.38.012 Boehringer Ingelheim Investigational Site, Sasima-gun, Ibaraki, Japan|1245.38.015 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo, Japan|1245.38.018 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo, Japan|1245.38.017 Boehringer Ingelheim Investigational Site, Suginami-ku, Tokyo, Japan|1245.38.022 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan|1245.38.023 Boehringer Ingelheim Investigational Site, Ube, Yamaguchi, Japan|1245.38.026 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa, Japan|1245.38.027 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa, Japan|1245.38.028 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa, Japan|1245.38.029 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa, Japan
URL: https://clinicaltrials.gov/show/NCT01193218

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