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

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ClinicalTrials.gov Identifier: NCT04018365
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Wataru Ogawa, Kobe University

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

Condition or disease Intervention/treatment Phase
Insulin Resistance - Type A Insulin Resistance - Type B Lipoatrophic Diabetes Mellitus Insulin Resistance Syndrome Drug: Empagliflozin Tablets Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : May 31, 2021


Arm Intervention/treatment
Experimental: Treatment of empagliflozin
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.
Drug: Empagliflozin Tablets
The administration is oral administration with water before or after breakfast.
Other Name: BI10773




Primary Outcome Measures :
  1. HbA1c change at Week 24 of the treatment from baseline [ Time Frame: 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 :
  1. HbA1c change rate at Week 24 of the treatment from baseline [ Time Frame: 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.

  2. HbA1c change at Week 12 of the treatment from baseline [ Time Frame: 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.

  3. HbA1c over time [ Time Frame: at Week 24 of the treatment from baseline ]
    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.

  4. Fasting plasma glucose (FPG) over time [ Time Frame: at Week 24 of the treatment from baseline ]
    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.

  5. FPG change at Week 24 of the treatment from baseline [ Time Frame: 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.

  6. Change of insulin dose [ Time Frame: at Week 24 of the treatment from baseline ]
    The insulin dose of each patient will be tabulated by time point.

  7. Postprandial glucose for 2 hours over time [ Time Frame: 2 Weeks from Day0 and Day140 ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018365


Contacts
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Contact: Yasumasa Kakei 81-78-382-5400 ctrcpj-empire@med.kobe-u.ac.jp
Contact: Hisayo Morioka 81-6-6202-5375 prj-empire-epcr@eps.co.jp

Locations
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Japan
Tohoku University Hospital Not yet recruiting
Sendai, Miyagi, Japan, 980-8574
Contact: Junta Imai, Associ.Prof.    81-22-717-7000      
Jichi Medical University Hospital Not yet recruiting
Shimotsuke, Tochigi, Japan, 329-0498
Contact: Ken Ebihara, Associ.Prof.    81-285-44-2111      
NIhon University Hospital Not yet recruiting
Chiyoda-ku, Tokyo, Japan, 101-8309
Contact: Tatsuhiko Urakami, Professor    81-3-3293-1711      
Okayama University Hospital Not yet recruiting
Okayama, Japan, 700-8558
Contact: Jun Wada, Professor    81-86-223-7151      
Sponsors and Collaborators
Kobe University
Boehringer Ingelheim
Investigators
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Study Chair: Wataru Ogawa Kobe University Hospital

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Responsible Party: Wataru Ogawa, Professor, Division of Diabetes and Endocrinology, Kobe University
ClinicalTrials.gov Identifier: NCT04018365     History of Changes
Other Study ID Numbers: 190012
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Wataru Ogawa, Kobe University:
insulin resistance
refractory diabetes mellitus

Additional relevant MeSH terms:
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Lipodystrophy, Congenital Generalized
Diabetes Mellitus
Insulin Resistance
Metabolic Syndrome
Diabetes Mellitus, Lipoatrophic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Diabetes Mellitus, Type 2
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Insulin
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action