Clinical trial NCT04221152: A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Insulin Resistance - Type A
Insulin Resistance - Type B
Lipoatrophic Diabetes Mellitus
Insulin Resistance Syndrome
Keywords: insulin resistance
refractory diabetes mellitus
Lead sponsor: Kobe University
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2020-01-09
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. A patient who completed the preceding EMPIRE-01 study and does not meet any discontinuation criteria
2. 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:

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 is exceeding 3-fold of upper limit of normal range prior to starting extension study treatment (Day 0)
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)
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 study period and would not agree to receive regular pregnancy tests during the study 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 prior to starting extension study treatment (Day 0)
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 coinvestigator, etc., has judged to be ineligible to this study for other reasons

Primary outcomes:
measure: Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs
timeFrame: until Week 28 (Week 52 of the EMPIRE-01 study)
Secondary outcomes:
measure: HbA1c change rate at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline
timeFrame: at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline
measure: HbA1c change at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline
timeFrame: at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline
measure: HbA1c at each time point
timeFrame: at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.
measure: Fasting plasma glucose (FPG) at each time point
timeFrame: at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.
measure: Fasting plasma glucose (FPG) change at Week 28 (52) of the treatment from baseline
timeFrame: between Week 28 (52) and baseline of the EMPIRE-01 study.
measure: Insulin dose at each time point (TDD, TBD)
timeFrame: at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.
measure: Postprandial glucose for 2 hours over time
timeFrame: for 14 days starting from Week 12 (36)
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Sendai
country: Japan
facility: Tohoku University Hospita
state: Miyagi
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: NIhon University Hospital
state: Tokyo
city: Okayama
country: Japan
facility: Okayama University Hospital
Study officials:
affiliation: Kobe University Hospital
name: Wataru Ogawa
role: STUDY_CHAIR
References: