FDA Approves Two New Treatment Alternatives for Diabetics

FDA Approves Two New Treatment Alternatives for Diabetics
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September 28, 2015

The U.S. Food and Drug Administration (FDA) has approved two new drugs to treat diabetes mellitus.

Late last week, the agency announced that both Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) had received approvals to improve blood sugar control in adults suffering from the condition.

"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, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in a written statement. "The FDA remains committed to support the development of innovative therapies for the treatment of diabetes."

Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Dosing should be individualized based on the patient's needs. Tresiba is administered subcutaneously once daily at any time of day.

The efficacy and safety of Tresiba was evaluated in controlled trials involving more than 3,800 participants suffering from either type-1 or type-2 diabetes. Treatment with the drug provided reductions in glycosylated hemoglobin, a measure of blood sugar control, in line with reductions achieved with other, previously approved long-acting insulin.

Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus.

Ryzodeg was tested in more than 1,300 patients with type-1 or type-2 diabetes who had inadequate blood sugar control at trial entry. Treatment provided reductions in glycosylated hemoglobin equivalent to reductions achieved with other, previously approved long-acting or pre-mixed insulin.

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

Both treatments options were developed by health care company Novo Nordisk.