Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589639
• Other study ID #: 1245.107
• Status: Completed
• Phase: Phase 4
• Start date: October 28, 2015
• Est. completion date: January 5, 2018

Study information

• Verified date: December 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: January 5, 2018
• Est. primary completion date: April 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Empagliflozin

• Placebo

• Placebo
For blinding purposes

Locations

Country	Name	City	State
Japan	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 Yamada Clinic	Hokkaido, Obihiro
Japan	Jiyugaoka Yokoyama Naika 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	Medical Corporation KEISEIKAI Kajiyama clinic	Kyoto, kyoto
Japan	Yoshimasa Diabetes & Endocrine 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 Center Clinic	Tokyo, Chuo-ku
Japan	Tokyo-Eki Center-building 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

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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

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