Clinical trial NCT02589639: Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
Official title: A 52-week Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Empagliflozin Once Daily, as an add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2015-10-28
Enrollment: 269
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus
* 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
* Further inclusion criteria apply

Exclusion criteria:

* Patients who experience uncontrolled hyperglycaemia before randomization
* 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
* Further exclusion criteria apply

Primary outcomes:
measure: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs)
timeFrame: From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Nakayama Clinic
city: Chiba, Kashiwa
country: Japan
facility: Kashiwa City Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Fukuoka, Yanagawa
country: Japan
facility: Seiwakai Medical Corporation Nagata Hospital
city: Fukuoka
country: Japan
facility: Kunisaki Makoto Clinic
city: Gunma, Maebashi
country: Japan
facility: Saiseikai Maebashi Hospital
city: Hiroshima, Fukuyama
country: Japan
facility: Nippon Kokan Fukuyama Hospital
city: Hokkaido, Obihiro
country: Japan
facility: Jiyugaoka Yokoyama Naika Clinic
city: Hokkaido, Obihiro
country: Japan
facility: Jiyugaoka Yamada Clinic
city: Hokkaido, Sapporo
country: Japan
facility: Souen Diabetes Clinic
city: Hyogo, Kobe
country: Japan
facility: Kotani Diabetes Clinic
city: Hyogo, Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central Hospital
city: Ibaraki, Ushiku
country: Japan
facility: Noritake Clinic
city: Kagawa
country: Japan
facility: Yokoi Medical Clinic, Kagawa, I.M.
city: Kagoshima, Kagoshima
country: Japan
facility: Izuro Imamura Hospital
city: Kagoshima, Satsumasendai
country: Japan
facility: Wakamatsu Memorial Hospital
city: Kagoshima
country: Japan
facility: Fukumoto clinic
city: Kanagawa, Atsugi
country: Japan
facility: STOP DM SUZUKI DIABETES CLINIC, Kanagawa, I.M.
city: Kanagawa, Kamakura
country: Japan
facility: Takai Naika Clinic
city: Kanagawa, Kawasaki
country: Japan
facility: Kokan Clinic
city: Kyoto, Kyoto
country: Japan
facility: Yoshimasa Diabetes & Endocrine Clinic
city: Kyoto, kyoto
country: Japan
facility: Medical Corporation KEISEIKAI Kajiyama clinic
city: Miyagi, Tagajo
country: Japan
facility: Saka General Clinic
city: Nagano, Kitaazumi-gun
country: Japan
facility: North Alps Medical Center Azumi Hospital
city: Nagano, Komoro
country: Japan
facility: Asama Nanroku Komoro Medical center
city: Oita, Oita
country: Japan
facility: Abe Clinic
city: Okayama, Tsuyama
country: Japan
facility: Tsuyama Chuo Hospital
city: Osaka, Neyagawa
country: Japan
facility: Medical Corporation Kyojinkai Clinic Komatsu
city: Osaka, Osaka
country: Japan
facility: Minamiosaka Hospital
city: Osaka, Suita
country: Japan
facility: OCROM Clinic
city: Osaka
country: Japan
facility: AMC Nishi-umeda Clinic
city: Osaka
country: Japan
facility: Shiraiwa Medical Clinic
city: Saitama, Ageo
country: Japan
facility: Ageo Central General Hospital
city: Saitama, Fujimi
country: Japan
facility: Medical Corporation Kaishinkai Masunaga Clinic
city: Saitama, Saitama
country: Japan
facility: Medical Corporation Fusa Shimizu Clinic Fusa
city: Tokyo, Adachi-ku
country: Japan
facility: Seiwa Clinic
city: Tokyo, Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Tokyo, Chiyoda-ku
country: Japan
facility: Chiyoda Houjin Clinic
city: Tokyo, Chiyoda-ku
country: Japan
facility: HDC Atlas Clinic
city: Tokyo, Chuo-ku
country: Japan
facility: Fukuwa Clinic
city: Tokyo, Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo, Chuo-ku
country: Japan
facility: Tokyo Center Clinic
city: Tokyo, Ota-ku
country: Japan
facility: Shin Clinic
city: Tokyo, Shinjuku-ku
country: Japan
facility: Shinjuku Research Park Clinic
city: Tokyo, Sumida-ku
country: Japan
facility: Sumida Chuou Hospital
city: Yamagata, Sagae
country: Japan
facility: Sagae City Hospital
city: Yamagata, Yamagata
country: Japan
facility: Clinic Sugiyama
city: Yamanashi, Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.