The US Food and Drug Administration (FDA) has approved two new drug treatments for diabetes: Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection).
The first newly-approved treatment, Tresiba, is a long-acting analogue insulin, injected once a day into the subcutaneous fat.
Tresiba was approved after a trial involving 1,102 participants. Each participant used Tresiba in combination with mealtime insulin for 26 and 52 weeks. A separate group of studies tested the effectiveness of Tresiba for people with type 2 diabetes. That study involved 2,702 participants.
Tresiba led to lower HbA1c levels in participants who struggled to control their blood glucose levels.
Ryzodeg 70/30, a mixture of insulin degludec (long-acting analogue insulin) and insulin aspart (rapid-acting human insulin analogue) was approved after similar trials. It was tested on 362 patients with type 1 diabetes over a 26-week trial, and on 998 patients with type 2 diabetes. Like Tresiba, Ryzodeg 70/30 improved HbA1c levels in people with type 1 and type 2 diabetes who had previously struggled to control their blood glucose levels.
The FDA approved the treatments, but noted that neither is suitable for people with diabetes who have increased ketones levels in their blood or urine.
Both drugs are manufactured by Novo Nordisk.
“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,” said Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Centre for Drug Evaluation and Research.
“The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”

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