FDA Approves Two New Treatments for Diabetes

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The FDA on Friday approved two formulations of insulin degludec injection to improve glucose control in adults with type 1 or type 2 diabetes. The long-acting insulin analog by itself will be marketed as Tresiba; when combined with insulin aspart, it will be marketed as Ryzodeg 70/30.

Tresiba should be taken subcutaneously once daily. The treatment, in combination with mealtime insulin, was tested in some 1100 adults with type 1 diabetes. It was also evaluated combined with mealtime insulin or oral diabetes drugs in roughly 2700 patients with type 2 diabetes. Ryzodeg combined with mealtime insulin was tested in some 360 adults with type 1 diabetes; its use once or twice daily was tested in nearly 1000 patients with type 2 diabetes.

Among trial patients with inadequate glucose control at baseline, both medications conferred hemoglobin A1c levels reductions similar to those seen with other long-acting insulins.

Tresiba and Ryzodeg should not be used in patients with diabetic ketoacidosis, the FDA notes.

Results from an ongoing cardiovascular outcomes trial of insulin degludec are expected in 2016, Reuters reports. The FDA originally rejected the insulin in 2013, asking for more data about its cardiovascular risks.