Trial participants also reported that the experimental glucagon was easy to use in the two late-phase trials.
Data from two new studies provide evidence that nasal glucagon could be an effective treatment for hypoglycemia in a real-world setting.
The two Phase III studies, funded by Eli Lilly and Locemia Solutions, aimed to gauge whether loved ones of people with type 1 diabetes could use nasal glucagon to treat moderate to severe lows in everyday life. Locemia and Lilly have partnered to develop the ready-to-use nasal glucagon powder as an alternative to injectable glucagon.
For the first study, 74 adults with type 1 diabetes and their loved ones were instructed to administer 3 mg of experimental nasal glucagon to treat moderate to severe bouts of hypoglycemia. During the study period, 69 of the trial participants had 157 hypoglycemic events; twelve of those bouts of hypoglycemia were considered severe.
Researchers found that nasal glucagon successfully resolved hypoglycemic events within 30 minutes for almost 96 percent of those trial participants who went low; this means that participants either regained consciousness or returned to a “normal state” within that timeframe. For all 12 bouts of severe lows (29 mg/dL to 60 mg/dL), participants regained consciousness or returned to “normality” within 15 minutes after the nasal glucagon was used.
It’s not immediately clear from the study text how researchers define “normal,” but we can be fairly certain that researchers are measuring more than just “normal” blood glucose levels. We know this because of the six bouts of hypoglycemia which did not meet this target within 30 minutes, four were because participants reported “headaches” or “nasal irritation” after that 30-minute window.
In the second, smaller study, researchers instructed caregivers of a small group of children and teens with type 1 diabetes to administer the nasal glucagon and then tracked how they used it to treat moderate to severe lows. During the study period, researchers gathered data from 33 moderate lows experienced by 14 children and teens with type 1; none of the minors experienced a severe low during the study period. All 33 of those lows resolved with the 30-minute window, with the minors returning to a “normal state,” as judged by the caregiver, and more than half of the lows resolved with 10 minutes.
Both studies tracked negative outcomes of nasal glucagon use. While there were no severe adverse events reported in either study, there were minor adverse events reported. The chief complaint among these reported events, by far, was “nasal irritation.”
Previous studies have found that nasal glucagon performed comparably to injectable glucagon for raising blood glucose levels. While the writeups of the two studies discussed how the nasal glucagon successfully raised blood glucose levels during the hypoglycemic events, the focus of the late-phase studies appeared to be on whether people could use the glucagon effectively in real-world situations and whether they felt satisfied with the outcomes after the glucagon was used.
Glucagon may be a great treatment option for hypoglycemia, but it often isn’t utilized during the most severe lows because people around people with type 1 diabetes do not feel comfortable injecting it when their loved ones are incapacitated. If nasal glucagon, or another easier-to-use glucagon, gains FDA approval in the future, it may find an eager market among the type 1 diabetes community.