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A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 ) (EMPIRE-02)

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ClinicalTrials.gov Identifier: NCT04221152
Recruitment Status : Active, not recruiting
First Posted : January 9, 2020
Last Update Posted : June 3, 2021
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Wataru Ogawa, Kobe University

Brief Summary:
A multicenter, open-label, single-arm, extension study with regard to the safety and efficacy 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 determine the safety and efficacy of oral administration of empagliflozin 10 mg or 25 mg once daily for 28 weeks (52 weeks of the EMPIRE-01 study) in subjects who participated in the EMPIRE-01 study, which was conducted on refractory diabetes mellitus patients with insulin resistance (insulin resistance syndrome, lipoatrophic diabetes mellitus) in a multicenter, open-label, single-arm, extension study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single-arm, Extension Study With Regard to the Safety and Efficacy of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance (EMPIRE-02)
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : May 31, 2022


Arm Intervention/treatment
Experimental: Treatment of empagliflozin

The study treatment shall be started from the next day of the Week 24 visit of the EMPIRE-01 study after enrollment. The investigational drug shall be administered at the same dosage as that of the empagliflozin tablet administered from Week 12 to Week 24 of the treatment period in the EMPIRE-01 study.

The administration is oral administration with water once daily before or after breakfast.

Drug: Empagliflozin Tablets
The administration is oral administration with water before or after breakfast.
Other Name: BI10773




Primary Outcome Measures :
  1. Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs [ Time Frame: until Week 28 (Week 52 of the EMPIRE-01 study) ]
    Presence/absence of adverse events, adverse drug reactions, and use of rescue treatment drugs


Secondary Outcome Measures :
  1. HbA1c change rate at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline [ Time Frame: at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline ]
    The HbA1c change rate at Week 28 (52) from baseline is defined as HbA1c change from baseline divided by baseline HbA1c of the EMPIRE-01 study and multiplied by 100.

  2. HbA1c change at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline [ Time Frame: at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline ]
    The HbA1c change at Week 28 (52) of the treatment from baseline is defined as the difference in HbA1c levels between Week 28 (52) and baseline of the EMPIRE-01 study.

  3. HbA1c at each time point [ Time Frame: at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation. ]
    The HbA1c at each time point is defined as the HbA1c levels at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.

  4. Fasting plasma glucose (FPG) at each time point [ Time Frame: at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation. ]
    The FPG at each time point is defined as the FPG levels at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.

  5. Fasting plasma glucose (FPG) change at Week 28 (52) of the treatment from baseline [ Time Frame: between Week 28 (52) and baseline of the EMPIRE-01 study. ]
    The FPG change at Week 28 (52) of the treatment from baseline is defined as the difference in the FPG levels between Week 28 (52) and baseline of the EMPIRE-01 study.

  6. Insulin dose at each time point (TDD, TBD) [ Time Frame: at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation. ]
    The TDD and TBD at each time point are defined as the insulin doses at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.

  7. Postprandial glucose for 2 hours over time [ Time Frame: for 14 days starting from Week 12 (36) ]
    Postprandial glucose for 2 hours shall be measured for 14 days starting from Week 12 (36) by using FreeStyle Librae ProTM.



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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 completed the preceding EMPIRE-01 study and does not meet any discontinuation criteria
  2. 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 is exceeding 3-fold of upper limit of normal range prior to starting extension study treatment (Day 0)
  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 study period and would not agree to receive regular pregnancy tests during the study 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 prior to starting extension study treatment (Day 0)
  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 coinvestigator, 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): NCT04221152


Locations
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Japan
Kobe University Hospital
Kobe, Hyogo, Japan, 650-0017
Tohoku University Hospita
Sendai, Miyagi, Japan, 980-8574
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan, 329-0498
NIhon University Hospital
Chiyoda-ku, Tokyo, Japan, 101-8309
Okayama University Hospital
Okayama, Japan, 700-8558
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: NCT04221152    
Other Study ID Numbers: 190020
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: June 2021
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
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
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs