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

NCT04221152 | Unknown Phase 3

• 1 other identifier: 190020
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

insulin resistance; refractory diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs

  Presence/absence of adverse events, adverse drug reactions, and use of rescue treatment drugs

  until Week 28 (Week 52 of the EMPIRE-01 study)

Secondary Outcomes (7)

• HbA1c change rate at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline

  at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline

• HbA1c change at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline

  at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline

• HbA1c at each time point

  at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.

• Fasting plasma glucose (FPG) at each time point

  at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.

• Fasting plasma glucose (FPG) change at Week 28 (52) of the treatment from baseline

  between Week 28 (52) and baseline of the EMPIRE-01 study.

Study Arms (1)

Treatment of empagliflozin

EXPERIMENTAL

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

Interventions

Empagliflozin Tablets DRUG

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

Also known as: BI10773

Treatment of empagliflozin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient who completed the preceding EMPIRE-01 study and does not meet any discontinuation criteria
• 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

You may not qualify if:

• 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
• 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)
• A patient who is receiving a systemic steroid at the time of consent (except for type B)
• A patient whose thyroid hormone product dose has been changed within 6 weeks before obtaining consent
• A patient with unstable endocrine diseases other than diabetes mellitus
• A patient with hemolysis or blood diseases that destabilize erythrocytic cells and other various disorders (e.g., malaria, babesiosis, hemolytic anemia)
• 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
• A patient who has experienced alcohol abuse or drug abuse within 3 months before obtaining consent, which may disturb the study participation
• A patient who is in the condition that makes it difficult to administer the study drug
• A patient with renal dysfunction of eGFR (MDRD calculating formula) \<45 mL/min/1.73 m2 prior to starting extension study treatment (Day 0)
• A patient who indicates a hypersensitivity response to empagliflozin or its excipients, or a patient with lactose-intolerance
• A patient with severe ketosis, diabetic coma or precoma, severe infection, perioperative status, or serious trauma
• A patient that the investigator and/or coinvestigator, etc., has judged to be ineligible to this study for other reasons

Sponsors & Collaborators

• Kobe University: lead
• Boehringer Ingelheim: collaborator

Study Sites (5)

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Tohoku University Hospita

Sendai, Miyagi, 980-8574, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

Location

NIhon University Hospital

Chiyoda-ku, Tokyo, 101-8309, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Insulin-Resistant, with Acanthosis Nigricans; Diabetes Mellitus, Lipoatrophic; Metabolic Syndrome; Insulin Resistance; Diabetes Mellitus

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Wataru Ogawa

  Kobe University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Diabetes and Endocrinology

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: February 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: May 31, 2022
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)