Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT02589639
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description empagliflozin 10 mg Empagliflozin - empagliflozin 10 mg Placebo - empagliflozin 25 mg Empagliflozin - empagliflozin 25 mg Placebo - placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment. Baseline and 16 weeks 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.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs) From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented
Trial Locations
- Locations (48)
Nishinomiya Municipal Central Hospital
🇯🇵Hyogo, Nishinomiya, Japan
North Alps Medical Center Azumi Hospital
🇯🇵Nagano, Kitaazumi-gun, Japan
Chiyoda Houjin Clinic
🇯🇵Tokyo, Chiyoda-ku, Japan
Kokan Clinic
🇯🇵Kanagawa, Kawasaki, Japan
AMC Nishi-umeda Clinic
🇯🇵Osaka, Japan
Fukuwa Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Noritake Clinic
🇯🇵Ibaraki, Ushiku, Japan
Kunisaki Makoto Clinic
🇯🇵Fukuoka, Japan
STOP DM SUZUKI DIABETES CLINIC, Kanagawa, I.M.
🇯🇵Kanagawa, Atsugi, Japan
Saka General Clinic
🇯🇵Miyagi, Tagajo, Japan
Asama Nanroku Komoro Medical center
🇯🇵Nagano, Komoro, Japan
Abe Clinic
🇯🇵Oita, Oita, Japan
Medical Corporation Kyojinkai Clinic Komatsu
🇯🇵Osaka, Neyagawa, Japan
Yoshimasa Diabetes & Endocrine Clinic
🇯🇵Kyoto, Kyoto, Japan
Medical Corporation KEISEIKAI Kajiyama clinic
🇯🇵Kyoto, kyoto, Japan
Ageo Central General Hospital
🇯🇵Saitama, Ageo, Japan
Medical Corporation Kaishinkai Masunaga Clinic
🇯🇵Saitama, Fujimi, Japan
Seiwa Clinic
🇯🇵Tokyo, Adachi-ku, Japan
Minamiosaka Hospital
🇯🇵Osaka, Osaka, Japan
OCROM Clinic
🇯🇵Osaka, Suita, Japan
Shiraiwa Medical Clinic
🇯🇵Osaka, Japan
Medical Corporation Fusa Shimizu Clinic Fusa
🇯🇵Saitama, Saitama, Japan
Juntendo University Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
HDC Atlas Clinic
🇯🇵Tokyo, Chiyoda-ku, Japan
Shin Clinic
🇯🇵Tokyo, Ota-ku, Japan
Tokyo Center Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Shinjuku Research Park Clinic
🇯🇵Tokyo, Shinjuku-ku, Japan
Sagae City Hospital
🇯🇵Yamagata, Sagae, Japan
Sumida Chuou Hospital
🇯🇵Tokyo, Sumida-ku, Japan
Clinic Sugiyama
🇯🇵Yamagata, Yamagata, Japan
Yamanashi Prefectural Central Hospital
🇯🇵Yamanashi, Kofu, Japan
Jiyugaoka Yamada Clinic
🇯🇵Hokkaido, Obihiro, Japan
Nakayama Clinic
🇯🇵Aichi, Japan
Kashiwa City Hospital
🇯🇵Chiba, Kashiwa, Japan
Seiwakai Medical Corporation Nagata Hospital
🇯🇵Fukuoka, Yanagawa, Japan
Saiseikai Fukuoka General Hospital
🇯🇵Fukuoka, Fukuoka, Japan
Nippon Kokan Fukuyama Hospital
🇯🇵Hiroshima, Fukuyama, Japan
Saiseikai Maebashi Hospital
🇯🇵Gunma, Maebashi, Japan
Jiyugaoka Yokoyama Naika Clinic
🇯🇵Hokkaido, Obihiro, Japan
Souen Diabetes Clinic
🇯🇵Hokkaido, Sapporo, Japan
Kotani Diabetes Clinic
🇯🇵Hyogo, Kobe, Japan
Yokoi Medical Clinic, Kagawa, I.M.
🇯🇵Kagawa, Japan
Izuro Imamura Hospital
🇯🇵Kagoshima, Kagoshima, Japan
Fukumoto clinic
🇯🇵Kagoshima, Japan
Wakamatsu Memorial Hospital
🇯🇵Kagoshima, Satsumasendai, Japan
Takai Naika Clinic
🇯🇵Kanagawa, Kamakura, Japan
Tsuyama Chuo Hospital
🇯🇵Okayama, Tsuyama, Japan