A multi-center study of empagliflozin in patients with refractory diabetes mellitus with insulin resistance

JRCT ID: jRCT2051190029

Registered date:26/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insulin resistance syndrome (type A, type B, type non-A non-B), Lipoatrophic diabetes mellitus
• Date of first enrollment: 10/10/2019
• Target sample size: 8
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: HbA1c change at Week 24 of the treatment from baseline

Secondary Outcome

(1)HbA1c change rate at Week 24 of the treatment from baseline
(2)HbA1c change at Week 12 of the treatment from baseline
(3)HbA1c over time
(4)Fasting plasma glucose (FPG) over time
(5)FPG change at Week 24 of the treatment from baseline
(6)Change of insulin dose (TDD, TBD)
(7) Postprandial glucose for 2 hours over time

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ogawa Wataru
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co ., Ltd.
• Secondary ID(s): NCT04018365