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Positive Results Reported for Insulin Degludec/Insulin Aspart (Ryzodeg) in Phase III Diabetes Trial

Combo therapy requires fewer injections than basal–bolus regimen

Data presented at the 50th annual meeting of the European Association for the Study of Diabetes (EASD) have shown that Ryzodeg (insulin degludec/insulin aspart, Novo Nordisk) administered twice daily provides successful glycemic control with fewer injections than a basal–bolus regimen.

Ryzodeg is a combination of two insulin analogues (insulin degludec and insulin aspart in a ratio of 70% and 30%, respectively), making it the first combination of a basal insulin with an ultra-long duration of action and a well-established mealtime insulin in one pen for patients with type-2 diabetes.

The study presented at EASD was a 26-week randomized phase IIIb trial in which 30 patients previously treated with basal insulin were randomly assigned to receive either twice-daily Ryzodeg or a basal–bolus regimen of once-daily insulin degludec plus two to four injections of insulin aspart.

The study did not meet its primary endpoint of non-inferiority; however, the results showed that hemoglobin A1c (HbA1c) was reduced in patients receiving either regimen — to 7.0% and 6.8% respectively — with no significant difference between the two regimens. Patients who received Ryzodeg experienced a numerically lower rate of overall and nocturnal confirmed hypoglycemic episodes (19% and 20% less, respectively). They also gained significantly less weight (P P

Type-2 diabetes is a progressive disease, which means that some patients will need to intensify insulin treatment by adding mealtime insulin (bolus therapy) to achieve or maintain their glycemic targets over time. Studies have shown that more than 50% of patients with type-2 diabetes receiving basal insulin alone do not achieve their glycemic targets, as measured by HbA1c. Complications from diabetes caused by failing to maintain optimal glycemic control can be serious and may include problems such as heart disease, stroke, blindness, kidney disease, nerve damage, and premature mortality.

Source: Novo Nordisk; September 18, 2014.

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