A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance (NCT04018365) | Clinical Trial Compass
UnknownPhase 3
A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance
Japan8 participantsStarted 2019-09-01
Plain-language 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
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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\) …
What they're measuring
1
HbA1c change at Week 24 of the treatment from baseline
Timeframe: at Week 24 of the treatment from baseline