We are pleased to share the results of our recently concluded ‘EASE’ clinical trial. This trial was testing the use of empagliflozin alongside insulin as a treatment for Type 1 Diabetes. Empagliflozin was already approved for use in patients with Type 2 Diabetes, so this study was testing it’s effectiveness in Type 1 patients. It was therefore a requirement of the study that participants needed to have Type 1 Diabetes and taking regular daily doses of insulin, either through multiple daily injections (MDI) or via an insulin pump.
The EASE study was conducted worldwide, with 12 volunteers recruited at Hunter Diabetes Centre. Participants received treatment over a 1 year period, randomly assigned to one of three treatment arms – 10mg empagliflozin, 25mg empagliflozin, and a placebo. The placebo arm of a study acts as a ‘control’, and is necessary for non-bias results. The study was also double-blinded, meaning neither the patient nor our staff knew which arm of the study a patient had been allocated to.
Patients attended our centre regularly throughout this period for assessment, which included checking of vital signs and measurements, any new illnesses or lifestyle changes, any changes in medication, and adherence to taking regular doses of the study medication. All this data was collected, and together with the other sites participating worldwide, contributed to the findings presented by study sponsor, Boehringer Ingelheim.
The main conclusion drawn from the EASE study was that empagliflozin improved glycemic control and weight in Type 1 Diabetes without increasing hypoglycemia. It was also noted that Ketoacidosis (DKA) rate was comparable between empagliflozin 2.5 mg and placebo but increased with 10 mg and 25 mg (ketone monitoring for early ketoacidosis detection and intervention and lower empagliflozin doses may help to reduce this risk). There was a plethora of other findings through the EASE study; to read the full study paper, click the link below. We’d like to thank all those participants who volunteered their time and energy to help us conduct this study. Your involvement helps us improve medical therapies and treatment for Diabetes.