Insulin analogs less likely to cause hypoglycemia in type 1 diabetes

By Will Boggs MD

NEW YORK (Reuters Health) - Insulin analogs (detemir/aspart) are less likely than human insulins (NPH/regular) to cause non-severe hypoglycemia in patients with type 1 diabetes who are prone to severe hypoglycemia, according to results from the industry-sponsored HypoAna trial.

"I believe that this study provides evidence for the clinical practice of using insulin analogs in the treatment of the approximately 20% of subjects with type 1 diabetes that suffer from recurrent severe hypoglycemia," Dr. Rikke M. Agesen from Nordsjaellands University Hospital, Hillerod, Denmark, told Reuters Health by email.

Such patients are usually excluded from clinical trials for safety reasons, so the effect of insulin analogs has not been previously addressed in them.

Dr. Agesen and colleagues investigated whether all-analog-insulin therapy in comparison with all-human-insulin therapy could reduce the rate of hypoglycemia events in a crossover study of 159 high-risk type 1 diabetes patients who experienced two or more episodes of severe hypoglycemia per year.

During analog insulin treatment, there was a small (1.4 mmol/L, 0.13%) but statistically significant reduction in HbA1c, the researchers report in Diabetes & Metabolism, online April 7.

In a per-protocol analysis of 114 patients, the rate of non-severe hypoglycemia events was significantly lower with insulin analog therapy than with human insulin therapy (53.3 vs. 57.9 events/patient-year).

Non-severe nocturnal episodes of hypoglycemia were also significantly less frequent with insulin analog therapy than with human insulin therapy (6.4 vs. 10.6 events/patient-year). Symptomatic nocturnal hypoglycemias declined by 48%, and asymptomatic nocturnal hypoglycemias declined by 28%.

"Only one previous trial has compared all-analog-insulin treatment with all-human-insulin treatment, and it was hypothesized that patients with recurrent hypoglycemia may also benefit from analog-based therapy," Dr. Agesen said. "The HypoAna trial verifies this hypothesis, both concerning the occurrence of severe and non-severe hypoglycemia, and, importantly, shows the size of the effect in relative and absolute terms in these high-risk patients."

"Studies in high-risk patients are feasible and may provide outcomes that compared to conventional randomized controlled trials are far more relevant for clinical practice as well as for regulatory authorities in the pharmacoeconomic assessment of new insulins," Dr. Agesen added. "We hope that the HypoAna trial may serve as an inspiration for future studies of new analogs. Presently, we are conducting a similar trial on insulin degludec in high-risk patients."

The study was funded by Novo Nordisk A/S. Several authors reported financial ties to the company.

SOURCE: http://bit.ly/1r1FpNd

Diabetes Metab 2016.

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