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Clinical Trial Details

Trial ID: L3222
Source ID: NCT02589639
Associated Drug: Empagliflozin
Title: Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02589639/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Empagliflozin|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment., The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment. The term "baseline" refers to the last observation prior to the administration of any randomised study drug. Means presented are the adjusted means., Baseline and 16 weeks | Secondary: Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs), Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented, From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 269
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-10-28
Completion Date: 2018-01-05
Results First Posted: 2019-03-27
Last Update Posted: 2019-03-27
Locations: Nakayama Clinic, Aichi, 456-0058, Japan|Kashiwa City Hospital, Chiba, Kashiwa, 277-0825, Japan|Saiseikai Fukuoka General Hospital, Fukuoka, Fukuoka, 810-0001, Japan|Seiwakai Medical Corporation Nagata Hospital, Fukuoka, Yanagawa, 832-0059, Japan|Kunisaki Makoto Clinic, Fukuoka, 819-0168, Japan|Saiseikai Maebashi Hospital, Gunma, Maebashi, 371-0821, Japan|Nippon Kokan Fukuyama Hospital, Hiroshima, Fukuyama, 721-0927, Japan|Jiyugaoka Yokoyama Naika Clinic, Hokkaido, Obihiro, 080-0016, Japan|Jiyugaoka Yamada Clinic, Hokkaido, Obihiro, 080-0848, Japan|Souen Diabetes Clinic, Hokkaido, Sapporo, 060-0011, Japan|Kotani Diabetes Clinic, Hyogo, Kobe, 657-0028, Japan|Nishinomiya Municipal Central Hospital, Hyogo, Nishinomiya, 663-8014, Japan|Noritake Clinic, Ibaraki, Ushiku, 300-1207, Japan|Yokoi Medical Clinic, Kagawa, I.M., Kagawa, 761-8075, Japan|Izuro Imamura Hospital, Kagoshima, Kagoshima, 892-0824, Japan|Wakamatsu Memorial Hospital, Kagoshima, Satsumasendai, 895-0052, Japan|Fukumoto clinic, Kagoshima, 891-0401, Japan|STOP DM SUZUKI DIABETES CLINIC, Kanagawa, I.M., Kanagawa, Atsugi, 243-0035, Japan|Takai Naika Clinic, Kanagawa, Kamakura, 247-0056, Japan|Kokan Clinic, Kanagawa, Kawasaki, 210-0852, Japan|Yoshimasa Diabetes & Endocrine Clinic, Kyoto, Kyoto, 604-8151, Japan|Medical Corporation KEISEIKAI Kajiyama clinic, Kyoto, kyoto, 615-0035, Japan|Saka General Clinic, Miyagi, Tagajo, 985-0835, Japan|North Alps Medical Center Azumi Hospital, Nagano, Kitaazumi-gun, 399-8695, Japan|Asama Nanroku Komoro Medical center, Nagano, Komoro, 384-8588, Japan|Abe Clinic, Oita, Oita, 870-0039, Japan|Tsuyama Chuo Hospital, Okayama, Tsuyama, 708-0841, Japan|Medical Corporation Kyojinkai Clinic Komatsu, Osaka, Neyagawa, 572-8567, Japan|Minamiosaka Hospital, Osaka, Osaka, 559-0012, Japan|OCROM Clinic, Osaka, Suita, 565-0853, Japan|AMC Nishi-umeda Clinic, Osaka, 530-0001, Japan|Shiraiwa Medical Clinic, Osaka, 582-0005, Japan|Ageo Central General Hospital, Saitama, Ageo, 362-8588, Japan|Medical Corporation Kaishinkai Masunaga Clinic, Saitama, Fujimi, 354-0031, Japan|Medical Corporation Fusa Shimizu Clinic Fusa, Saitama, Saitama, 336-0963, Japan|Seiwa Clinic, Tokyo, Adachi-ku, 123-0845, Japan|Juntendo University Hospital, Tokyo, Bunkyo-ku, 113-8431, Japan|Chiyoda Houjin Clinic, Tokyo, Chiyoda-ku, 101-0024, Japan|HDC Atlas Clinic, Tokyo, Chiyoda-ku, 102-0082, Japan|Fukuwa Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Tokyo-Eki Center-building Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Tokyo Center Clinic, Tokyo, Chuo-ku, 103-0028, Japan|Shin Clinic, Tokyo, Ota-ku, 144-0051, Japan|Shinjuku Research Park Clinic, Tokyo, Shinjuku-ku, 169-0073, Japan|Sumida Chuou Hospital, Tokyo, Sumida-ku, 131-0046, Japan|Sagae City Hospital, Yamagata, Sagae, 991-8508, Japan|Clinic Sugiyama, Yamagata, Yamagata, 990-0885, Japan|Yamanashi Prefectural Central Hospital, Yamanashi, Kofu, 400-8506, Japan
URL: https://clinicaltrials.gov/show/NCT02589639

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