Trials with SGLT2 inhibitor in addition to insulin meet primary efficacy endpoint in type 1 diabetes patients
Two trials in the EASE phase III program evaluating the efficacy of empagliflozin in combination with insulin therapy met their primary endpoint of change from baseline in HbA1c after 26 weeks of treatment in type 1 diabetes (T1DM) patients. This was the case for all investigated doses of empagliflozin (2.5, 10 and 25 mg).
The safety profile of empagliflozin appeared to be similar to that in other trials with a higher number of patients with ketoacidosis events in patients with 10 and 25 mg empagliflozin compared to the placebo group.
The Empagliflozin as Adjunctive to inSulin thErapy (EASE) phase III program includes two multinational, double-blinded, placebo-controlled phase III clinical trials investigating the efficacy, safety and tolerability of once-daily empagliflozin in combination with insulin in T1DM patients. EASE-2 evaluated 10 and 25 mg doses empagliflozin vs placebo for 52 weeks in 720 patients. EASE-3 compared 2.5, 10 and 25 mg doses empagliflozin vs placebo for 26 weeks in 960 patients.
The full results from the EASE phase III programme will be presented at the European Association for the Study of Diabetes Annual Meeting on 4th October, 2018 in Berlin, Germany. Empagliflozin is currently not approved for use in T1DM patients.
“Despite recent advances in insulin therapy and patient care, optimal glucose control is difficult to achieve in people with type 1 diabetes. Empagliflozin is an effective and well-established medicine used to treat adults with type 2 diabetes, and our comprehensive clinical trial programme continues to investigate the potential benefits it may offer to a range of adults with diabetes”, said Dr. Jyothis George, Global Head of Clinical Development, Therapeutic Area CardioMetabolism, Boehringer Ingelheim.