More Good News on Degludec

Type 1 diabetes patients who took a new combined formulation of insulins degludec and aspart (IDegAsp) at their main meal, with insulin aspart (IAsp) at other meals, had better nocturnal glycemic control than patients on basal-bolus therapy with insulin detemir (IDet) and IAsp.

Patients in the IDegAsp group took IAsp at breakfast, with another injection at lunch, if necessary. Overall, they needed fewer injections, and had fewer episodes of nocturnal hypoglycemia, compared to the insulin detemir group, the researchers said.

Dr. Irl B. Hirsch, who led the study stated that, "While it is important this was shown with the coformulation, meaning this degree of glycemic control can be achieved with fewer injections than the traditional basal bolus therapy used in type 1 diabetes, I don't believe a co-formulation will become the standard of care in this population where we generally prefer more flexibility with the prandial insulin."

Novo Nordisk is hoping to market IDegAsp as Ryzodeg and has submitted the product for regulatory review in North America, Europe, Japan, South Africa, India, Australia, Brazil, and Russia. In June, the U.S. Food and Drug Administration extended its review period for Ryzodeg; some action is expected later this quarter.

In the meantime, in an August 28 paper in Diabetes Care, Dr. Hirsch of the University of Washington Medical Center-Roosevelt, Seattle, and colleagues noted that standard basal-bolus therapy typically requires four to five daily injections.

They randomly assigned 548 patients to therapy with IDegAsp or IDet. After 26 weeks of treatment, hemoglobin A1C decreased in both treatment groups to 7.6%. Patients in the IDegAsp group improved by a mean of 0.75%, and the IDet patients improved by a mean 0.70%.

There were no significant differences in the rates of severe hypoglycemia or of overall confirmed hypoglycemia between groups. However, the confirmed nocturnal hypoglycemia rate was a significant 37% lower with IDegAsp vs IDet (3.71 vs 5.72 episodes per patient-year).

There were fewer daily injections with IDegAsp (three vs four to five), and the total insulin dose was 13% lower. However, weight gain was 1 kg greater at 26 weeks (2.3 vs 1.3 kg).

There were no differences in Health-Related Quality of Life or lab measurements, or in adverse events.

The researchers conclude that the approach "is as efficacious and well tolerated as a standard basal-bolus regimen, with the added benefits of a significantly lower risk of nocturnal hypoglycemia and fewer daily injections."

But, Dr. Hirsch added, "We can't comment how this coformulation would perform with tighter levels of glucose control and A1C levels less than 7%. Nevertheless, for some type 1 patients who may do better with a coformulation of degludec with insulin aspart, the same benefit of reduced nocturnal hypoglycemia can be expected."

Diabetes Care Sept. 2012