Nasal Spray Effective in Hypoglycemia Rescue

An intranasal glucagon spray is as good as injectable glucagon for treating hypoglycemia in patients with type 1 diabetes, according to a new study.

Researchers at the University of Pennsylvania (Philadelphia, PA, USA), Yale University (New Haven, CT, USA), and other institutions conducted a randomized crossover non-inferiority study involving 75 adults volunteers with type 1 diabetes (mean age 33 years, with diabetes for a median of 18 years). Study participants underwent two glucagon dosing visits, scheduled 1-4 weeks apart. In the first visit they were randomly assigned to receive either 3 mg of intranasal glucagon or 1 mg of intramuscular glucagon, with the other preparation given during the second visit in a crossover fashion.

Each visit was conducted after an overnight fast, following which the investigators induced hypoglycemia by an infusion of insulin. Once glucose concentration dropped to less than 60 mg/dL, the insulin infusion was stopped. Five minutes later, the investigators administered the glucagon, and collected blood samples for glucose at regular intervals for 90 minutes. Insulin levels were measured upon administration of glucagon and 30 and 60 minutes afterward. The investigators also assessed hypoglycemic symptoms at baseline and at regular intervals.

The results showed that success criteria were met in all the intramuscular and in all but one of the intranasal administrations; in the one initially unsuccessful intranasal case, success criteria were reached at 40 minutes instead of the pre-specified 30 minutes. The rise in glucose concentrations after intranasal glucagon lagged behind that of intramuscular by about 3 minutes. Symptoms of hypoglycemia were greater in the intranasal group for the first 45 minutes after administration but were similar after that, while plasma insulin levels were similar in both groups. The study was published on December 17, 2015, in Diabetes Care.

“A needle-free intranasal preparation is likely to be preferred due to its relative simplicity compared with injectable formulations, particularly since individuals who must administer rescue glucagon are usually not trained medical professionals,” said lead author Michael Rickels, MD, of the University of Pennsylvania. “The slight delay in glycemic response would likely be clinically inconsequential and in many circumstances might be offset by the time required, errors, and failures to deliver among nonmedical caregivers in preparing and administering the injectable intramuscular formulation.”

Glucagon is a peptide hormone produced naturally by alpha cells of the pancreas that raises the concentration of glucose in the bloodstream. Its effect is opposite that of insulin, which lowers the glucose concentration. As a result, glucagon and insulin are part of a feedback system that keeps blood glucose levels at a stable level. The intranasal glucagon used in the study came in a single-use device designed to shoot a dry powder up the nasal passages when a plunger is depressed.

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University of Pennsylvania
Yale University