NEW YORK (Reuters Health) – Insulin degludec, an ultra-long-acting basal insulin, provides glycemic control in type 1 diabetes similar to that of insulin glargine but with lower occurrence of hypoglycemia, according to the results of a phase II trial reported in Diabetes Care online January 26.

Meanwhile, confirmatory results from two phase III trials have set the stage for a launch of Degludec and DegludecPlus in 2013. “We have said that we will submit in both Europe and the U.S. new drug applications for these products simultaneously if at all possible towards the end of next year,” Novo Nordisk chief science officer Mads Krogsgaard Thomsen said in a Reuters report at the end of last December. “And that is still the case,” he said, adding results from the remaining trials in the phase III program would be released early in February.

The ultra-long effect of insulin degludec results from the slow release of insulin monomers from soluble multihexamers that form after subcutaneous injection, the authors of the current report explain. This produces a long half-life and a smooth and stable pharmacokinetic profile at steady state.

For their phase II study, Dr. Kare I. Birkeland, at Oslo University Hospital, Norway, and colleagues conducted a 16-week open-label trial in 178 patients with type 1 diabetes in five countries. They were randomized to receive insulin degludec 600 micromol/L or 900 micromol/L, or insulin glargine, injected subcutaneously daily before bedtime. All took insulin aspart at mealtimes.

At the end of the study, A1C was similar in the three arms at 7.8%, 8.0% and 7.6%, respectively. Fasting plasma glucose levels were 8.3, 8.3 and 8.9 mmol/L, respectively, according to the report.

The rate ratio for confirmed hypoglycemia was 0.72 for the lower-strength insulin degludec and 0.90 for the higher-strength formulation, compared to insulin glargine. Corresponding rate ratios for nocturnal hypoglycemia were 0.42 and 0.71.

As for side effects, “The frequency and pattern of adverse events was similar between insulin treatments,” the investigators found.

The results “strongly support” the continued clinical development of the 600-micromol/L formulation of insulin degludec, the authors say, but clinical development of the 900-micromol/L formulation has been discontinued.

In summary,” Dr. Birkeland and colleagues conclude, “this clinical trial showed that insulin degludec, used in combination with mealtime insulin aspart, is a well-tolerated and efficacious treatment when used in people with type 1 diabetes, providing comparable glycemic control to insulin glargine at comparable doses, but with lower rates of hypoglycemia.”

Reference:

Insulin Degludec in Type 1 Diabetes
A randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine


Diabetes Care 2011.