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

Primary Purpose

Insulin Resistance - Type A, Insulin Resistance - Type B, Lipoatrophic Diabetes Mellitus

Status

Unknown status

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Empagliflozin Tablets

About this trial

This is an interventional treatment trial for Insulin Resistance - Type A focused on measuring insulin resistance, refractory diabetes mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Kobe University Hospital
Tohoku University Hospita
Jichi Medical University Hospital
NIhon University Hospital
Okayama University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment of empagliflozin

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c change rate 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.

HbA1c change 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.

HbA1c at each time point

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.

Fasting plasma glucose (FPG) at each time point

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.

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

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.

Insulin dose at each time point (TDD, TBD)

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.

Postprandial glucose for 2 hours over time

Postprandial glucose for 2 hours shall be measured for 14 days starting from Week 12 (36) by using FreeStyle Librae ProTM.

Full Information

NCT ID

NCT04221152

First Posted

January 6, 2020

Last Updated

June 2, 2021

Sponsor

Kobe University

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT04221152

Brief Title

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

Acronym

EMPIRE-02

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

February 1, 2022 (Anticipated)

Study Completion Date

May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kobe University

Collaborators

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

insulin resistance, refractory diabetes mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment of empagliflozin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Empagliflozin Tablets

Other Intervention Name(s)

BI10773

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

HbA1c at each time point

Description

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.

Time Frame

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

Title

Fasting plasma glucose (FPG) at each time point

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

Insulin dose at each time point (TDD, TBD)

Description

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.

Time Frame

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

Title

Postprandial glucose for 2 hours over time

Description

Postprandial glucose for 2 hours shall be measured for 14 days starting from Week 12 (36) by using FreeStyle Librae ProTM.

Time Frame

for 14 days starting from Week 12 (36)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wataru Ogawa

Organizational Affiliation

Kobe University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Kobe University Hospital

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Tohoku University Hospita

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

Jichi Medical University Hospital

City

Shimotsuke

State/Province

Tochigi

ZIP/Postal Code

329-0498

Country

Japan

Facility Name

NIhon University Hospital

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

101-8309

Country

Japan

Facility Name

Okayama University Hospital

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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