Study protocol
BLOOD
Medical history, concomitant therapies, smoking status, and working status were collected during the baseline visit. A physical examination including body mass index (BMI), waist circumference, blood pressure and heart rate was performed. Blood samples were collected after 12 h of fasting. Subsequently, every patient proceeded with a 2-hour oral glucose tolerance test (OGTT). A CMR imaging was performed after completion of the OGTT. Thereafter, patients were randomized to either 25 mg of empagliflozin once daily or placebo. All patients received a diary together with equipment for self-monitoring of blood glucose and were scheduled for follow-up at the outpatient clinic one and three months later. Seven months after randomization all investigations performed during the baseline visit were repeated. Thereafter, the study drug was stopped and three months later (i.e., ten months after randomization) all patients returned for a final visit including all investigations; this off-drug period was carried out to investigate whether the potential impact of the drug was long-lasting.A safety evaluation during the time on study drug was conducted on all patients.
Changes in plasma glucose levels and HbA1c from baseline to after seven months on study drug. Legend: HbA1c: glycated haemoglobin A1c