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

NCT ID: NCT04018365

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-10-30

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

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

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.

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 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

• 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 Hospital

Sendai, Miyagi, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

NIhon University Hospital

Chiyoda-ku, Tokyo, Japan

Okayama University Hospital

Okayama, , Japan

Countries

Japan

References

Hirota Y, Kakei Y, Imai J, Katagiri H, Ebihara K, Wada J, Suzuki J, Urakami T, Omori T, Ogawa W. A Multicenter, Open-Label, Single-Arm Trial of the Efficacy and Safety of Empagliflozin Treatment for Refractory Diabetes Mellitus with Insulin Resistance (EMPIRE-01). Diabetes Ther. 2024 Feb;15(2):533-545. doi: 10.1007/s13300-023-01526-x. Epub 2024 Jan 13.

Reference Type: DERIVED

PMID: 38216831 (View on PubMed)

Other Identifiers

190012

Identifier Type: -

Identifier Source: org_study_id