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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Empagliflozin
Placebo
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nakayama Clinic
  • Kashiwa City Hospital
  • Saiseikai Fukuoka General Hospital
  • Seiwakai Medical Corporation Nagata Hospital
  • Kunisaki Makoto Clinic
  • Saiseikai Maebashi Hospital
  • Nippon Kokan Fukuyama Hospital
  • Jiyugaoka Yokoyama Naika Clinic
  • Jiyugaoka Yamada Clinic
  • Souen Diabetes Clinic
  • Kotani Diabetes Clinic
  • Nishinomiya Municipal Central Hospital
  • Noritake Clinic
  • Yokoi Medical Clinic, Kagawa, I.M.
  • Izuro Imamura Hospital
  • Wakamatsu Memorial Hospital
  • Fukumoto clinic
  • STOP DM SUZUKI DIABETES CLINIC, Kanagawa, I.M.
  • Takai Naika Clinic
  • Kokan Clinic
  • Yoshimasa Diabetes & Endocrine Clinic
  • Medical Corporation KEISEIKAI Kajiyama clinic
  • Saka General Clinic
  • North Alps Medical Center Azumi Hospital
  • Asama Nanroku Komoro Medical center
  • Abe Clinic
  • Tsuyama Chuo Hospital
  • Medical Corporation Kyojinkai Clinic Komatsu
  • Minamiosaka Hospital
  • OCROM Clinic
  • AMC Nishi-umeda Clinic
  • Shiraiwa Medical Clinic
  • Ageo Central General Hospital
  • Medical Corporation Kaishinkai Masunaga Clinic
  • Medical Corporation Fusa Shimizu Clinic Fusa
  • Seiwa Clinic
  • Juntendo University Hospital
  • Chiyoda Houjin Clinic
  • HDC Atlas Clinic
  • Fukuwa Clinic
  • Tokyo-Eki Center-building Clinic
  • Tokyo Center Clinic
  • Shin Clinic
  • Shinjuku Research Park Clinic
  • Sumida Chuou Hospital
  • Sagae City Hospital
  • Clinic Sugiyama
  • Yamanashi Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

empagliflozin 10 mg

empagliflozin 25 mg

placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs)
Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented

Full Information

First Posted
October 27, 2015
Last Updated
December 11, 2018
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02589639
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 28, 2015 (Actual)
Primary Completion Date
April 18, 2017 (Actual)
Study Completion Date
January 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
empagliflozin 10 mg
Arm Type
Experimental
Arm Title
empagliflozin 25 mg
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
For blinding purposes
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.
Description
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.
Time Frame
Baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs)
Description
Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented
Time Frame
From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Nakayama Clinic
City
Aichi
ZIP/Postal Code
456-0058
Country
Japan
Facility Name
Kashiwa City Hospital
City
Chiba, Kashiwa
ZIP/Postal Code
277-0825
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
Seiwakai Medical Corporation Nagata Hospital
City
Fukuoka, Yanagawa
ZIP/Postal Code
832-0059
Country
Japan
Facility Name
Kunisaki Makoto Clinic
City
Fukuoka
ZIP/Postal Code
819-0168
Country
Japan
Facility Name
Saiseikai Maebashi Hospital
City
Gunma, Maebashi
ZIP/Postal Code
371-0821
Country
Japan
Facility Name
Nippon Kokan Fukuyama Hospital
City
Hiroshima, Fukuyama
ZIP/Postal Code
721-0927
Country
Japan
Facility Name
Jiyugaoka Yokoyama Naika Clinic
City
Hokkaido, Obihiro
ZIP/Postal Code
080-0016
Country
Japan
Facility Name
Jiyugaoka Yamada Clinic
City
Hokkaido, Obihiro
ZIP/Postal Code
080-0848
Country
Japan
Facility Name
Souen Diabetes Clinic
City
Hokkaido, Sapporo
ZIP/Postal Code
060-0011
Country
Japan
Facility Name
Kotani Diabetes Clinic
City
Hyogo, Kobe
ZIP/Postal Code
657-0028
Country
Japan
Facility Name
Nishinomiya Municipal Central Hospital
City
Hyogo, Nishinomiya
ZIP/Postal Code
663-8014
Country
Japan
Facility Name
Noritake Clinic
City
Ibaraki, Ushiku
ZIP/Postal Code
300-1207
Country
Japan
Facility Name
Yokoi Medical Clinic, Kagawa, I.M.
City
Kagawa
ZIP/Postal Code
761-8075
Country
Japan
Facility Name
Izuro Imamura Hospital
City
Kagoshima, Kagoshima
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Wakamatsu Memorial Hospital
City
Kagoshima, Satsumasendai
ZIP/Postal Code
895-0052
Country
Japan
Facility Name
Fukumoto clinic
City
Kagoshima
ZIP/Postal Code
891-0401
Country
Japan
Facility Name
STOP DM SUZUKI DIABETES CLINIC, Kanagawa, I.M.
City
Kanagawa, Atsugi
ZIP/Postal Code
243-0035
Country
Japan
Facility Name
Takai Naika Clinic
City
Kanagawa, Kamakura
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Kokan Clinic
City
Kanagawa, Kawasaki
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Yoshimasa Diabetes & Endocrine Clinic
City
Kyoto, Kyoto
ZIP/Postal Code
604-8151
Country
Japan
Facility Name
Medical Corporation KEISEIKAI Kajiyama clinic
City
Kyoto, kyoto
ZIP/Postal Code
615-0035
Country
Japan
Facility Name
Saka General Clinic
City
Miyagi, Tagajo
ZIP/Postal Code
985-0835
Country
Japan
Facility Name
North Alps Medical Center Azumi Hospital
City
Nagano, Kitaazumi-gun
ZIP/Postal Code
399-8695
Country
Japan
Facility Name
Asama Nanroku Komoro Medical center
City
Nagano, Komoro
ZIP/Postal Code
384-8588
Country
Japan
Facility Name
Abe Clinic
City
Oita, Oita
ZIP/Postal Code
870-0039
Country
Japan
Facility Name
Tsuyama Chuo Hospital
City
Okayama, Tsuyama
ZIP/Postal Code
708-0841
Country
Japan
Facility Name
Medical Corporation Kyojinkai Clinic Komatsu
City
Osaka, Neyagawa
ZIP/Postal Code
572-8567
Country
Japan
Facility Name
Minamiosaka Hospital
City
Osaka, Osaka
ZIP/Postal Code
559-0012
Country
Japan
Facility Name
OCROM Clinic
City
Osaka, Suita
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
AMC Nishi-umeda Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Shiraiwa Medical Clinic
City
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Facility Name
Ageo Central General Hospital
City
Saitama, Ageo
ZIP/Postal Code
362-8588
Country
Japan
Facility Name
Medical Corporation Kaishinkai Masunaga Clinic
City
Saitama, Fujimi
ZIP/Postal Code
354-0031
Country
Japan
Facility Name
Medical Corporation Fusa Shimizu Clinic Fusa
City
Saitama, Saitama
ZIP/Postal Code
336-0963
Country
Japan
Facility Name
Seiwa Clinic
City
Tokyo, Adachi-ku
ZIP/Postal Code
123-0845
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Chiyoda Houjin Clinic
City
Tokyo, Chiyoda-ku
ZIP/Postal Code
101-0024
Country
Japan
Facility Name
HDC Atlas Clinic
City
Tokyo, Chiyoda-ku
ZIP/Postal Code
102-0082
Country
Japan
Facility Name
Fukuwa Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Tokyo Center Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Shin Clinic
City
Tokyo, Ota-ku
ZIP/Postal Code
144-0051
Country
Japan
Facility Name
Shinjuku Research Park Clinic
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Sumida Chuou Hospital
City
Tokyo, Sumida-ku
ZIP/Postal Code
131-0046
Country
Japan
Facility Name
Sagae City Hospital
City
Yamagata, Sagae
ZIP/Postal Code
991-8508
Country
Japan
Facility Name
Clinic Sugiyama
City
Yamagata, Yamagata
ZIP/Postal Code
990-0885
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Yamanashi, Kofu
ZIP/Postal Code
400-8506
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35472672
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

Learn more about this trial

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

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