The FDA has approved two new insulins — Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) — for the improvement of blood glucose control in adults with diabetes, according to a press release from the agency.
Tresiba is a long-acting insulin analog indicated for the improvement of glycemic control in adults with type 1 and type 2 diabetes. The drug is administered subcutaneously once daily at any time of day, and dosing should be tailored to the individual patient.
Researchers evaluated the safety and efficacy of Tresiba in combination with mealtime insulin in patients with type 1 diabetes in two 26-week and one 52-week active-controlled clinical trials. A total of 1,102 participants received Tresiba.
Similarly, Tresiba was evaluated in combination with mealtime insulin or as an add-on to common background oral antidiabetes drugs in patients with type 2 diabetes in four 26-week and two 52-week active-controlled clinical trials. A total of 2,702 participants received Tresiba.
Participants with type 1 and type 2 diabetes who had inadequate glycemic control at study initiation achieved reductions in HbA1c when treated with Tresiba that were comparable to those seen with other previously approved long-acting insulins, according to the agency release.
The second drug to receive FDA approval, Ryzodeg 70/30, which combines a long-acting insulin analog (insulin degludec) with a rapid-acting human insulin analog (insulin aspart), is also indicated for improvement of glycemic control in adults with diabetes.
Researchers assessed the safety and efficacy of Ryzodeg 70/30 in combination with mealtime insulin in patients with type 1 diabetes in one 26-week active-controlled clinical trial involving 362 participants who received Ryzodeg 70/30.
Additionally, safety and efficacy of Ryzodeg 70/30 administered once or twice daily in patients with type 2 diabetes were evaluated in four active-controlled 26-week clinical trials. A total of 998 participants received Ryzodeg 70/30.
Results showed that, in patients with type 1 and type 2 diabetes who had inadequate glycemic control at study entry, Ryzodeg 70/30 yielded reductions in HbA1c that were on par with those observed with previously approved long-acting or pre-mixed insulin.
Hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, edema and weight gain were the most common adverse events associated with Tresiba and Ryzodeg in clinical trials.
“Long-acting insulins play an essential role in the treatment of patients with type 1 diabetes and in patients with type 2 diabetes with advanced disease,” Jean-Marc Guettier, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in the release.
“The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”
The agency stated that Tresiba and Ryzodeg should not be used in those with diabetic ketoacidosis and that the drugs may cause hypoglycemia. As with all insulin regimens, patients and caregivers should carefully monitor blood glucose.