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A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance (EMPIRE-01)

Primary Purpose

Insulin Resistance - Type A, Insulin Resistance - Type B, Lipoatrophic Diabetes Mellitus

Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Empagliflozin Tablets
Sponsored by
Kobe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance - Type A focused on measuring insulin resistance, refractory diabetes mellitus

Eligibility Criteria

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

Inclusion Criteria:

  • 1) A patient who has been diagnosed with insulin resistance syndrome (type A, type B, type non-A non-B) or lipoatrophic diabetes mellitus prior to obtaining consent
  • 2) A patient who has received consistent dosage and administration of drugs aiming a hypoglycemic effect and consistent instructions of diet therapy/exercise therapy for more than 12 weeks before enrollment
  • 3) A patient with >= 7.0 % of HbA1c at the time of screening
  • 4) A patient, if taking other SGLT2 inhibitor than empagliflozin, whose SGLT2 inhibitor can be washed out for more than 12 weeks prior to starting empagliflozin
  • 5) A patient at the age of >=20 years at the time of consent
  • 6) A patient who has received sufficient explanation with regard to information such as the objectives and details of this study, expected drug efficacy/pharmacological action, and risks, and has given written consent by her/himself.

Exclusion Criteria:

  • 1) A patient with a medical history of acute coronary syndrome (including non-ST-elevation myocardial infarction, ST-elevation myocardial infarction, and unstable angina pectoris), stroke or transient ischemic attack (TIA) within 3 months before obtaining consent
  • 2) A patient with suspected hepatic dysfunction, that either of serum ALT, AST or alkaline phosphatase in the screening period is exceeding 3-fold of upper limit of normal rang
  • 3) A patient who is receiving a systemic steroid at the time of consent (except for type B)
  • 4) A patient whose thyroid hormone product dose has been changed within 6 weeks before obtaining consent
  • 5) A patient with unstable endocrine diseases other than diabetes mellitus
  • 6) A patient with hemolysis or blood diseases that destabilize erythrocytic cells and other various disorders (e.g., malaria, babesiosis, hemolytic anemia).
  • 7) A premenopausal female patient (the latest menstruation was within 1 year before obtaining consent), a lactating or pregnant patient, or a patient who may be pregnant (without hysterectomy or ovariectomy) who has no intention to use efficacious contraception defined in this study during the treatment period and would not agree to receive regular pregnancy tests during the treatment period
  • 8) A patient who has experienced alcohol abuse or drug abuse within 3 months before obtaining consent, which may disturb the study participation
  • 9) A patient who is in the condition that makes it difficult to administer the study drug
  • 10) A patient with renal dysfunction of eGFR (MDRD calculating formula) < 45 mL/min/1.73 m2 in the screening period
  • 11) A patient who indicates a hypersensitivity response to empagliflozin or its excipients, or a patient with lactose-intolerance
  • 12) A patient with severe ketosis, diabetic coma or precoma, severe infection, perioperative status, or serious trauma
  • 13) A patient that the investigator and/or subinvestigator, etc., has judged to be ineligible to this study for other reasons

Sites / Locations

  • Kobe University Hospital
  • Tohoku University Hospital
  • Jichi Medical University Hospital
  • NIhon University Hospital
  • Okayama University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment of empagliflozin

Arm Description

Empagliflozin 10 mg is to be continuously administered once daily for 12 weeks. Measure an HbA1c level after 12 weeks and determine the dose (Week 13 to Week 24). In case of <7.0%, 10 mg will be continued: in case of >=7.0%, it will be increased to 25 mg.

Outcomes

Primary Outcome Measures

HbA1c change at Week 24 of the treatment from baseline
With regard to the HbA1c change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.

Secondary Outcome Measures

HbA1c change rate at Week 24 of the treatment from baseline
With regard to the HbA1c change rate at Week 24 of the treatment from baseline, change rates will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.
HbA1c change at Week 12 of the treatment from baseline
With regard to the HbA1c change at Week 12 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.
HbA1c over time
The HbA1c level at measurement time point is tabulated by patient, as well as plotting the HbA1c level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of HbA1c at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph.
Fasting plasma glucose (FPG) over time
The FPG level at measurement time point is tabulated by patient, as well as plotting the FPG level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of FPG at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph.
FPG change at Week 24 of the treatment from baseline
With regard to the FPG change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.
Change of insulin dose
The insulin dose of each patient will be tabulated by time point.
Postprandial glucose for 2 hours over time
The postprandial glucose for 2 hours at measurement time point is tabulated by patient, and the glucose level over time is plotted by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of postprandial glucose for 2 hours at each time point will be tabulated, and the mean at each measurement time point with an error bar of standard deviation will be displayed by line graph.

Full Information

First Posted
July 10, 2019
Last Updated
March 1, 2021
Sponsor
Kobe University
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04018365
Brief Title
A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance
Acronym
EMPIRE-01
Official Title
A Multicenter, Open-label, Single-arm Study With Regard to the Efficacy and Safety of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kobe University
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A multicenter, open-label, single-arm study with regard to the efficacy and safety of empagliflozin in patients with refractory diabetes mellitus with insulin resistance
Detailed Description
To evaluate the clinical efficacy of a treatment with empagliflozin in refractory diabetes mellitus patients with insulin resistance (insulin resistance syndrome, lipoatrophic diabetes mellitus) by using the HbA1c change at Week 24 of treatment from baseline

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance - Type A, Insulin Resistance - Type B, Lipoatrophic Diabetes Mellitus, Insulin Resistance Syndrome
Keywords
insulin resistance, refractory diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment of empagliflozin
Arm Type
Experimental
Arm Description
Empagliflozin 10 mg is to be continuously administered once daily for 12 weeks. Measure an HbA1c level after 12 weeks and determine the dose (Week 13 to Week 24). In case of <7.0%, 10 mg will be continued: in case of >=7.0%, it will be increased to 25 mg.
Intervention Type
Drug
Intervention Name(s)
Empagliflozin Tablets
Other Intervention Name(s)
BI10773
Intervention Description
The administration is oral administration with water before or after breakfast.
Primary Outcome Measure Information:
Title
HbA1c change at Week 24 of the treatment from baseline
Description
With regard to the HbA1c change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.
Time Frame
at Week 24 of the treatment from baseline
Secondary Outcome Measure Information:
Title
HbA1c change rate at Week 24 of the treatment from baseline
Description
With regard to the HbA1c change rate at Week 24 of the treatment from baseline, change rates will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.
Time Frame
at Week 24 of the treatment from baseline
Title
HbA1c change at Week 12 of the treatment from baseline
Description
With regard to the HbA1c change at Week 12 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.
Time Frame
at Week 12 of the treatment from baseline
Title
HbA1c over time
Description
The HbA1c level at measurement time point is tabulated by patient, as well as plotting the HbA1c level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of HbA1c at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph.
Time Frame
at Week 24 of the treatment from baseline
Title
Fasting plasma glucose (FPG) over time
Description
The FPG level at measurement time point is tabulated by patient, as well as plotting the FPG level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of FPG at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph.
Time Frame
at Week 24 of the treatment from baseline
Title
FPG change at Week 24 of the treatment from baseline
Description
With regard to the FPG change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.
Time Frame
at Week 24 of the treatment from baseline
Title
Change of insulin dose
Description
The insulin dose of each patient will be tabulated by time point.
Time Frame
at Week 24 of the treatment from baseline
Title
Postprandial glucose for 2 hours over time
Description
The postprandial glucose for 2 hours at measurement time point is tabulated by patient, and the glucose level over time is plotted by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of postprandial glucose for 2 hours at each time point will be tabulated, and the mean at each measurement time point with an error bar of standard deviation will be displayed by line graph.
Time Frame
2 Weeks from Day0 and Day140

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) A patient who has been diagnosed with insulin resistance syndrome (type A, type B, type non-A non-B) or lipoatrophic diabetes mellitus prior to obtaining consent 2) A patient who has received consistent dosage and administration of drugs aiming a hypoglycemic effect and consistent instructions of diet therapy/exercise therapy for more than 12 weeks before enrollment 3) A patient with >= 7.0 % of HbA1c at the time of screening 4) A patient, if taking other SGLT2 inhibitor than empagliflozin, whose SGLT2 inhibitor can be washed out for more than 12 weeks prior to starting empagliflozin 5) A patient at the age of >=20 years at the time of consent 6) A patient who has received sufficient explanation with regard to information such as the objectives and details of this study, expected drug efficacy/pharmacological action, and risks, and has given written consent by her/himself. Exclusion Criteria: 1) A patient with a medical history of acute coronary syndrome (including non-ST-elevation myocardial infarction, ST-elevation myocardial infarction, and unstable angina pectoris), stroke or transient ischemic attack (TIA) within 3 months before obtaining consent 2) A patient with suspected hepatic dysfunction, that either of serum ALT, AST or alkaline phosphatase in the screening period is exceeding 3-fold of upper limit of normal rang 3) A patient who is receiving a systemic steroid at the time of consent (except for type B) 4) A patient whose thyroid hormone product dose has been changed within 6 weeks before obtaining consent 5) A patient with unstable endocrine diseases other than diabetes mellitus 6) A patient with hemolysis or blood diseases that destabilize erythrocytic cells and other various disorders (e.g., malaria, babesiosis, hemolytic anemia). 7) A premenopausal female patient (the latest menstruation was within 1 year before obtaining consent), a lactating or pregnant patient, or a patient who may be pregnant (without hysterectomy or ovariectomy) who has no intention to use efficacious contraception defined in this study during the treatment period and would not agree to receive regular pregnancy tests during the treatment period 8) A patient who has experienced alcohol abuse or drug abuse within 3 months before obtaining consent, which may disturb the study participation 9) A patient who is in the condition that makes it difficult to administer the study drug 10) A patient with renal dysfunction of eGFR (MDRD calculating formula) < 45 mL/min/1.73 m2 in the screening period 11) A patient who indicates a hypersensitivity response to empagliflozin or its excipients, or a patient with lactose-intolerance 12) A patient with severe ketosis, diabetic coma or precoma, severe infection, perioperative status, or serious trauma 13) A patient that the investigator and/or subinvestigator, etc., has judged to be ineligible to this study for other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wataru Ogawa
Organizational Affiliation
Kobe University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
NIhon University Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance

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