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

NCT ID: NCT04221152

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-05-31

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.

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.

Conditions

Insulin Resistance - Type A; Insulin Resistance - Type B; Lipoatrophic Diabetes Mellitus; Insulin Resistance Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Empagliflozin Tablets

Intervention Type: DRUG

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

Interventions

Empagliflozin Tablets

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

Intervention Type: DRUG

Other Intervention Names

BI10773

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Kobe University

INDUSTRY

Sponsor Role: lead

Responsible Party

Wataru Ogawa

Professor, Division of Diabetes and Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wataru Ogawa

Role: STUDY_CHAIR

Kobe University Hospital

Locations

Kobe University Hospital

Kobe, Hyōgo, Japan

Tohoku University Hospita

Sendai, Miyagi, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

NIhon University Hospital

Chiyoda-ku, Tokyo, Japan

Okayama University Hospital

Okayama, , Japan

Countries

Japan

Other Identifiers

190020

Identifier Type: -

Identifier Source: org_study_id