Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
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
1 other identifier
interventional
269
1 country
48
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Oct 2015
Typical duration for phase_4 diabetes-mellitus-type-2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedStudy Start
First participant enrolled
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2018
CompletedResults Posted
Study results publicly available
March 27, 2019
CompletedMarch 27, 2019
December 1, 2018
1.5 years
October 27, 2015
December 11, 2018
December 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
empagliflozin 10 mg
EXPERIMENTALempagliflozin 25 mg
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (48)
Nakayama Clinic
Aichi, 456-0058, Japan
Kashiwa City Hospital
Chiba, Kashiwa, 277-0825, Japan
Kunisaki Makoto Clinic
Fukuoka, 819-0168, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, 810-0001, Japan
Seiwakai Medical Corporation Nagata Hospital
Fukuoka, Yanagawa, 832-0059, 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
Fukumoto clinic
Kagoshima, 891-0401, Japan
Izuro Imamura Hospital
Kagoshima, Kagoshima, 892-0824, Japan
Wakamatsu Memorial Hospital
Kagoshima, Satsumasendai, 895-0052, 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
AMC Nishi-umeda Clinic
Osaka, 530-0001, Japan
Shiraiwa Medical Clinic
Osaka, 582-0005, 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
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
Related Publications (1)
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.
PMID: 35472672DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2015
First Posted
October 28, 2015
Study Start
October 28, 2015
Primary Completion
April 18, 2017
Study Completion
January 5, 2018
Last Updated
March 27, 2019
Results First Posted
March 27, 2019
Record last verified: 2018-12