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Insulin Resistance - Type APhase 3EMPIRE-01NCT04018365

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

A Phase 3 study testing Empagliflozin Tablets in people with Insulin Resistance - Type A and Insulin Resistance - Type B, run by Kobe University at 5 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Empagliflozin Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
5 sitesJapan
Study dates
1 Sep 2019to 30 Oct 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 13Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Japan5 sites

  • NIhon University Hospital

    Chiyoda-ku, Tokyo, 101-8309

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Okayama University Hospital

    Okayama, 700-8558

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

Other trials in Japan

About this study

Official title: 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

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

Read the 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

Being tested
Empagliflozin Tablets
Keywords
insulin resistance, refractory diabetes mellitus
Medical subject headings
Diabetes Mellitus, Insulin-Resistant, with Acanthosis Nigricans, Diabetes Mellitus, Lipoatrophic, Metabolic Syndrome, Insulin Resistance, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin TabletsDrug

    Also called BI10773

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

Study groups in NCT04018365
Study groupRoleWhat they receive
Treatment of empagliflozinExperimentalEmpagliflozin 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.
Receives: Drug: Empagliflozin Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at Week 24 of the treatment from baseline

Secondary outcomes (7)

  1. HbA1c change rate at Week 24 of the treatment from baseline

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

    Measured: at Week 24 of the treatment from baseline

  2. HbA1c change at Week 12 of the treatment from baseline

    With regard to the HbA1c change at Week 12 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.

    Measured: at Week 12 of the treatment from baseline

  3. HbA1c over time

    The HbA1c level at measurement time point is tabulated by patient, as well as plotting the HbA1c level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of HbA1c at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph.

    Measured: at Week 24 of the treatment from baseline

  4. Fasting plasma glucose (FPG) over time

    The FPG level at measurement time point is tabulated by patient, as well as plotting the FPG level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of FPG at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph.

    Measured: at Week 24 of the treatment from baseline

  5. FPG change at Week 24 of the treatment from baseline

    With regard to the FPG 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.

    Measured: at Week 24 of the treatment from baseline

  6. Change of insulin dose

    The insulin dose of each patient will be tabulated by time point.

    Measured: at Week 24 of the treatment from baseline

  7. Postprandial glucose for 2 hours over time

    The postprandial glucose for 2 hours at measurement time point is tabulated by patient, and the glucose level over time is plotted by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of postprandial glucose for 2 hours at each time point will be tabulated, and the mean at each measurement time point with an error bar of standard deviation will be displayed by line graph.

    Measured: 2 Weeks from Day0 and Day140

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2019
  2. Study start1 Sep 2019
  3. Primary completion31 Jul 2021 (estimated)
  4. Study completion30 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04018365
Sponsor's protocol ID
190012
Acronym
EMPIRE-01
Status last verified
Mar 2021
First submitted
10 Jul 2019
Last updated
3 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38216831

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin Tablets in people with Insulin Resistance - Type A and Insulin Resistance - Type B, run by Kobe University at 5 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c change at Week 24 of the treatment from baseline (time frame: at Week 24 of the treatment from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04018365, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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