NCT04018365

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

July 10, 2019

Last Update Submit

March 1, 2021

Conditions

Insulin Resistance - Type AInsulin Resistance - Type BLipoatrophic Diabetes MellitusInsulin Resistance Syndrome

Keywords

insulin resistancerefractory diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c change at Week 24 of the treatment from baseline

    With regard to the HbA1c change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum.

    at Week 24 of the treatment from baseline

Secondary Outcomes (7)

  • HbA1c change rate at Week 24 of the treatment from baseline

    at Week 24 of the treatment from baseline

  • HbA1c change at Week 12 of the treatment from baseline

    at Week 12 of the treatment from baseline

  • HbA1c over time

    at Week 24 of the treatment from baseline

  • Fasting plasma glucose (FPG) over time

    at Week 24 of the treatment from baseline

  • FPG change at Week 24 of the treatment from baseline

    at Week 24 of the treatment from baseline

  • +2 more secondary outcomes

Study Arms (1)

Treatment of empagliflozin

EXPERIMENTAL

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.

Drug: Empagliflozin Tablets

Interventions

Empagliflozin TabletsDRUG

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

Also known as: BI10773
Treatment of empagliflozin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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
  • \) 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
  • \) A patient with \>= 7.0 % of HbA1c at the time of screening
  • \) 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
  • \) A patient at the age of \>=20 years at the time of consent
  • \) 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 in the screening period is exceeding 3-fold of upper limit of normal rang
  • \) 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 treatment period and would not agree to receive regular pregnancy tests during the treatment 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 in the screening period
  • \) 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 subinvestigator, etc., has judged to be ineligible to this study for other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Tohoku University Hospital

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

Related Publications (1)

  • 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.

    PMID: 38216831DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Insulin-Resistant, with Acanthosis NigricansDiabetes Mellitus, LipoatrophicMetabolic SyndromeInsulin ResistanceDiabetes Mellitus

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

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

July 10, 2019

First Posted

July 12, 2019

Study Start

September 1, 2019

Primary Completion

July 31, 2021

Study Completion

October 30, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(5)