A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Res… (NCT04221152) | Clinical Trial Compass
UnknownPhase 3
A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )
Japan8 participantsStarted 2020-02-01
Plain-language 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.
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
✓. 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
Exclusion criteria
✕. 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)
✕. 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
What they're measuring
1
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)