Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
NCT ID: NCT02589639
Last Updated: 2019-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
269 participants
INTERVENTIONAL
2015-10-28
2018-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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empagliflozin 10 mg
Empagliflozin
Placebo
For blinding purposes
empagliflozin 25 mg
Empagliflozin
Placebo
For blinding purposes
placebo
Placebo
Placebo
For blinding purposes
Interventions
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Empagliflozin
Placebo
Placebo
For blinding purposes
Eligibility Criteria
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Inclusion Criteria
* Patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening
* Fasting C-peptide must be \> 0.5 ng/mL
* HbA1c at screening in Patients who are treated with insulin alone must be \>=7.5% and \<=10.0%
* HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD) must be \>=7.0% and \<=9.5% at screening, and \>=7.5% and \<=10.0% at placebo run-in period
* Age at informed consent must be \>=20 and \<75 years
* BMI at screening must be \>22 and \<=40 kg/m2
Exclusion Criteria
* Patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (SGLT-2) inhibitor
* Patients with recent cardiovascular and/or stroke events
* Patients with hepatic and/or renal dysfunction
* Patients who received anti-obesity drugs or other treatment leading to unstable body weight
* Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin
* Pre-menopausal women who are nursing or pregnant
20 Years
74 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Nakayama Clinic
Aichi, , Japan
Kashiwa City Hospital
Chiba, Kashiwa, , Japan
Kunisaki Makoto Clinic
Fukuoka, , Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, , Japan
Seiwakai Medical Corporation Nagata Hospital
Fukuoka, Yanagawa, , Japan
Saiseikai Maebashi Hospital
Gunma, Maebashi, , Japan
Nippon Kokan Fukuyama Hospital
Hiroshima, Fukuyama, , Japan
Jiyugaoka Yokoyama Naika Clinic
Hokkaido, Obihiro, , Japan
Jiyugaoka Yamada Clinic
Hokkaido, Obihiro, , Japan
Souen Diabetes Clinic
Hokkaido, Sapporo, , Japan
Kotani Diabetes Clinic
Hyogo, Kobe, , Japan
Nishinomiya Municipal Central Hospital
Hyogo, Nishinomiya, , Japan
Noritake Clinic
Ibaraki, Ushiku, , Japan
Yokoi Medical Clinic, Kagawa, I.M.
Kagawa, , Japan
Fukumoto clinic
Kagoshima, , Japan
Izuro Imamura Hospital
Kagoshima, Kagoshima, , Japan
Wakamatsu Memorial Hospital
Kagoshima, Satsumasendai, , Japan
STOP DM SUZUKI DIABETES CLINIC, Kanagawa, I.M.
Kanagawa, Atsugi, , Japan
Takai Naika Clinic
Kanagawa, Kamakura, , Japan
Kokan Clinic
Kanagawa, Kawasaki, , Japan
Yoshimasa Diabetes & Endocrine Clinic
Kyoto, Kyoto, , Japan
Medical Corporation KEISEIKAI Kajiyama clinic
Kyoto, Kyoto, , Japan
Saka General Clinic
Miyagi, Tagajo, , Japan
North Alps Medical Center Azumi Hospital
Nagano, Kitaazumi-gun, , Japan
Asama Nanroku Komoro Medical center
Nagano, Komoro, , Japan
Abe Clinic
Oita, Oita, , Japan
Tsuyama Chuo Hospital
Okayama, Tsuyama, , Japan
AMC Nishi-umeda Clinic
Osaka, , Japan
Shiraiwa Medical Clinic
Osaka, , Japan
Medical Corporation Kyojinkai Clinic Komatsu
Osaka, Neyagawa, , Japan
Minamiosaka Hospital
Osaka, Osaka, , Japan
OCROM Clinic
Osaka, Suita, , Japan
Ageo Central General Hospital
Saitama, Ageo, , Japan
Medical Corporation Kaishinkai Masunaga Clinic
Saitama, Fujimi, , Japan
Medical Corporation Fusa Shimizu Clinic Fusa
Saitama, Saitama, , Japan
Seiwa Clinic
Tokyo, Adachi-ku, , Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, , Japan
Chiyoda Houjin Clinic
Tokyo, Chiyoda-ku, , Japan
HDC Atlas Clinic
Tokyo, Chiyoda-ku, , Japan
Fukuwa Clinic
Tokyo, Chuo-ku, , Japan
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, , Japan
Tokyo Center Clinic
Tokyo, Chuo-ku, , Japan
Shin Clinic
Tokyo, Ota-ku, , Japan
Shinjuku Research Park Clinic
Tokyo, Shinjuku-ku, , Japan
Sumida Chuou Hospital
Tokyo, Sumida-ku, , Japan
Sagae City Hospital
Yamagata, Sagae, , Japan
Clinic Sugiyama
Yamagata, Yamagata, , Japan
Yamanashi Prefectural Central Hospital
Yamanashi, Kofu, , Japan
Countries
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References
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Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1245.107
Identifier Type: -
Identifier Source: org_study_id
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