SAN DIEGO — Giving one puff of a dry glucagon powder inside the nose of an adult with type 1 diabetes who was having a moderate to severe hypoglycemic episode was easy for a caregiver to do and led to recovery within 30 minutes in almost all patients in a phase 3 study.
Specifically, the treated patients recovered from hypoglycemia within a half hour in 96% of cases, and 90% of the caregivers (typically a spouse) found the product easy to use, Elizabeth R Seaquist, MD, University of Minnesota School of Medicine, Minneapolis, reported at the recent American Diabetes Association (ADA) 2017 Scientific Sessions.
“We conclude that this 3-mg dose of nasal glucagon in a needle-free, user-friendly package provides a potential alternative to currently available injectable recombinant glucagon,” she said.
“It really does look like [this investigational product] could be a good alternative to [intramuscular injectable] glucagon for treating severe hypoglycemia away from a hospital setting,” she reiterated to Medscape Medical News.
Even after caregivers are taught how to prepare and use injectable glucagon, “they don’t usually use it” and may feel powerless waiting for the paramedics to arrive, according to Dr Seaquist.
Session chair Raimund I Herzog, MD, from the Yale School of Medicine, New Haven, Connecticut, agreed. It would be “very exciting” to have this new option to treat hypoglycemia, he said.
In October 2015, Eli Lilly acquired the global rights for the nasal product, which was originally developed by the Canadian company Locemia Solutions.
Lilly plans to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) in the first half of 2018, which will include the current study, Chad Grothen, global brand development lead, Lilly Diabetes, told Medscape Medical News in an email.
“It is premature to comment on when the product will be available in the US,” he cautioned, but if the NDA is approved, “we are excited to bring this product to market as quickly as possible.”
Preparing Injectable Glucagon Can Be Confusing
Treatment for severe hypoglycemia outside of a hospital setting is “limited to injectable glucagon, [which] requires several steps, including reconstitution, and is prone to error,” explained Dr Seaquist during her presentation. “People can’t [easily] put together the injectable glucagon, [and they] get very confused about doing that.”
Intranasal glucagon, on the other hand, was designed to be simple to administer.
Previous studies have demonstrated successful use of intranasal glucagon in children with type 1 diabetes and in adults when administered by trained laypeople, and it has been shown to be effective for normalizing blood glucose in a trial that compared it with intramuscular glucagon for hypoglycemia.
The current study aimed to evaluate efficacy (recovery within 30 minutes) and ease of use of 3 mg of this nasal product when patients experienced hypoglycemic episodes in a real-world setting.
For patients with severe hypoglycemia, who were unconscious or having seizures, recovery was defined as awakening. For patients with moderate hypoglycemia, who had a blood glucose of about 60 mg/dL or less, recovery was defined as a return to a normal state.
The study enrolled patients at multiple sites in the United States and Canada who were 18 to 75 years old and had type 1 diabetes.
The efficacy analysis included 69 patients with complete information, and the safety analysis also included five other patients with missing time-to-response information.
On average, the patients were in their mid-40s and had had diabetes for 27 years. Half were using insulin pumps and the others were using multiple daily injections of insulin.
One in five patients had had severe hypoglycemia in the 30 days before enrollment, and only 8% had never had severe hypoglycemia.
The 69 patients experienced 157 hypoglycemia episodes during the course of the study.
In 151 hypoglycemic events (96% of cases), the patients returned to normal or awakened within 30 minutes. In five of the six other cases, the patients recovered at 30 to 45 minutes. The remaining patient had a headache that persisted for a longer time.
The patients had a mean blood glucose of 48 mg/dL at hypoglycemia onset that rose to 113 mg/dL by 30 minutes and continued to rise.
Seven patients had convulsions and three patients were unconscious, but these patients all awoke or returned to a normal state within 30 minutes.
Caregivers Did Not Need to Phone 911
“Importantly, in this study, 911 was not called for any of the episodes of severe…or moderate hypoglycemia,” said Dr Seaquist.
The adverse events were mild to moderate and transient and included nausea and vomiting (which is known to occur with glucagon) and nasal irritation related to the route of administration.
Most caregivers were very satisfied and speedily administered the nasal glucagon: 97% reported that they could deliver the drug in under 2 minutes, and three-quarters could do this in 30 seconds.
Almost all caregivers found that the kit instructions were easy to understand (96%) and the drug was easy to administer (90%), and they were satisfied with the product (94%).
The same dose has been tested in children with type 1 diabetes, and the product could potentially also be used by patients with type 2 diabetes who take insulin and could have severe hypoglycemia, Dr Seaquist said.
The study was funded by Eli Lilly. Dr Seaquist is a consultant and author for Eli Lilly and Novo Nordisk. Disclosures for the coauthors are listed in the abstract.
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American Diabetes Association 2017 Scientific Sessions; June 12, 2016; San Diego, California. Abstract 357-OR
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