Clinical trial NCT04018365: A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance
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
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: 2019-07-12
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 study with regard to the efficacy and safety of empagliflozin in patients with refractory diabetes mellitus with insulin resistance

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

Eligibility criteria: Inclusion Criteria:

* 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.

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 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).
* 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

Primary outcomes:
measure: HbA1c change at Week 24 of the treatment from baseline
timeFrame: at Week 24 of the treatment from baseline
Secondary outcomes:
measure: HbA1c change rate at Week 24 of the treatment from baseline
timeFrame: at Week 24 of the treatment from baseline
measure: HbA1c change at Week 12 of the treatment from baseline
timeFrame: at Week 12 of the treatment from baseline
measure: HbA1c over time
timeFrame: at Week 24 of the treatment from baseline
measure: Fasting plasma glucose (FPG) over time
timeFrame: at Week 24 of the treatment from baseline
measure: FPG change at Week 24 of the treatment from baseline
timeFrame: at Week 24 of the treatment from baseline
measure: Change of insulin dose
timeFrame: at Week 24 of the treatment from baseline
measure: Postprandial glucose for 2 hours over time
timeFrame: 2 Weeks from Day0 and Day140
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Sendai
country: Japan
facility: Tohoku University Hospital
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: