FDA approves Tresiba, Ryzodeg for type 1, type 2 diabetes

The FDA has approved Tresiba and Ryzodeg for glucose control in adults with type 1 or type 2 diabetes.

Tresiba (insulin degludec injection, Novo Nordisk) is a long-acting insulin analogue indicated to improve glycemic control in adults with type 1or 2 diabetes when administered subcutaneously once daily at any time of day. In a meta-analysis of five phase 3a randomized intention-to-treat trials comparing once-daily insulin degludec (n = 2,262) with insulin glargine (n = 1,110) in patients with type 2 diabetes, researchers found that insulin degludec was associated with a 27% lower rate of recurrent hypoglycemia in patients treated with basal-bolus therapy. Additionally, insulin degludec did not increase the risk for hypoglycemia among those treated with oral medications.

Ryzodeg 70/30 (insulin degludec/insulin aspart injection, Novo Nordisk) is a mixture of insulin degludec, a long-acting insulin analogue, and insulin aspart, a rapid-acting human insulin analogue, also designed to improve glycemic control. Ryzodeg can be administered once or twice daily with any meal.

The FDA cautioned that both drugs can cause hypoglycemia and should not be used in adults with increased ketones in their blood or urine.

The most common adverse events associated with the two drugs in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema and weight gain.