Eli Lilly and Co. and Boehringer Ingelheim GmbH said their medicine Jardiance was effective in changing blood sugar levels compared to placebo in patients with type 1 diabetes, according to full results of two phase 3 studies.
Patients with type 1 diabetes do not produce enough insulin and must administer insulin to regulate blood sugar levels.
Jardiance, or empagliflozin, is already approved to treat type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes, but is not approved for treatment of type 1 diabetes. The companies evaluated Jardiance versus placebo as an additional treatment to insulin therapy in two phase 3 studies called Ease-2 and Ease-3, according to an Oct. 4 press release. The goal of the Ease program was to determine if the drug could benefit type 1 diabetes patients.
Indianapolis-based Lilly and Germany's Boehringer reported initial data from these studies in June.
The Ease-2 study treated 720 patients with 10-milligram and 25-milligram doses of Jardiance over 52 weeks, while the Ease-3 study treated 960 patients with 2.5-milligram, 10-milligram, and 25-milligram doses. Both studies met their main goal of a change in A1C, a blood test that shows average blood glucose levels over the past three months, after 26 weeks of treatment.
The companies, however, said the number of events of diabetic ketoacidosis — a potentially life-threatening complication of diabetes — was higher in Jardiance 10-milligram and 25-milligram doses than placebo. Cases of diabetic ketoacidosis were comparable between Jardiance 2.5 milligrams and placebo. The companies said given the risk of diabetic ketoacidosis for people with type 1 diabetes, the 2.5-milligram Jardiance dose "warrants consideration" for treatment of type 1 diabetes because the medicine balances glycemic and metabolic improvements that are relevant to patients without increasing their risk of diabetic ketoacidosis or other serious adverse events.
Boehringer said that based on the complete data, it has initiated regulatory discussions for Jardiance as an adjunct treatment to insulin for adults with type 1 diabetes.