Insulin Resistance - Type APhase 3EMPIRE-02NCT04221152
A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )
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.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Insulin Resistance - Type A, Insulin Resistance - Type B, Lipoatrophic Diabetes Mellitus
- 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 Feb 2020to 31 May 2022
- 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
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
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 Hospita
Sendai, Miyagi, 980-8574
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
About this study
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)
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.
Read the 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.
- Conditions
- Insulin Resistance - Type A, Insulin Resistance - Type B, Lipoatrophic Diabetes Mellitus, Insulin Resistance Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Empagliflozin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
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.
Measured: at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: for 14 days starting from Week 12 (36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Feb 2020
- Primary completion1 Feb 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Resistance - Type AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Wataru Ogawa, Kobe University
- Investigators
- Wataru Ogawa, Study chair, Kobe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221152
- Sponsor's protocol ID
- 190020
- Acronym
- EMPIRE-02
- Status last verified
- Jun 2021
- First submitted
- 6 Jan 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04221152
- Acronym / sponsor ID
- EMPIRE-02 / 190020
- Conditions
- Insulin Resistance - Type A, Insulin Resistance - Type B, Lipoatrophic Diabetes Mellitus, Insulin Resistance Syndrome
- Keywords
- insulin resistance, refractory diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of empagliflozin | Experimental | Drug: Empagliflozin TabletsThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin TabletsAlso: BI10773The administration is oral administration with water before or after breakfast. | Drug | Treatment of empagliflozin |
Primary outcome
Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs
Time frame: until Week 28 (Week 52 of the EMPIRE-01 study)
Presence/absence of adverse events, adverse drug reactions, and use of rescue treatment drugs
7 secondary outcomes
HbA1c change rate at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline
Time frame: 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
Time frame: at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline
HbA1c at each time point
Time frame: at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.
Fasting plasma glucose (FPG) at each time point
Time frame: 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
Time frame: between Week 28 (52) and baseline of the EMPIRE-01 study.
Insulin dose at each time point (TDD, TBD)
Time frame: at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.
Postprandial glucose for 2 hours over time
Time frame: for 14 days starting from Week 12 (36)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wataru Ogawa study chair
Kobe University Hospital
5 sites in 1 country: see every site and its status.
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 2 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 Jun 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?
Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs (time frame: until Week 28 (Week 52 of the EMPIRE-01 study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2021.