麻豆传媒

SAN DIEGO -- A novel formulation of glucagon administered as a dry mist nasal spray showed real-world effectiveness when administered to treat moderate or severe hypoglycemia in adults with type 1 diabetes, researchers reported here.

In the efficacy population, 69 patients had a total of 157 hypoglycemic episodes treated with nasal glucagon, with blood glucose levels ranging from 21.6 to 73.9 mg/dL, said Elizabeth Seaquist, MD, of the University of Minnesota in Minneapolis, and colleagues.

For most hypoglycemic episodes (96.2%), patients recovered within 30 minutes and there were no emergency calls, Seaquist reported in a presentation at the American Diabetes Association meeting.

The researchers found just six episodes in which the recovery did not occur within 30 minutes: five events where patients recovered within 30 to 45 minutes and four events where blood glucose was ≥70 mg/dL at 30 minutes.

Seaquist, who is also a consultant for Eli Lilly, explained that hormone glucagon raises blood glucose levels and is used in response to life-threatening hypoglycemia, an event which sends nearly 300,000 Americans to the emergency department each year. Nasal glucagon could be a potential alternative to injectable glucagon which is commonly used for hypoglycemia in hospital, she said.

"We know we get lots of prescriptions filled and people don't use it because it is hard to use ... you have to reconstitute it, and it has a needle, and people get afraid. It's very exciting as a clinician, as someone who takes care of patients with diabetes and who helps the families to be ready for hypoglycemia, to have another option," Seaquist told 麻豆传媒.

Seaquist's group invited adults who had type 1 diabetes for more than a year and their caregivers to participate in the real-world trial. Both patients and caregivers were taught to administer 3 mg of nasal glucagon in powder form for symptomatic hypoglycemic episodes and to assess for return to normal status over time.

Seaquist described the needle-free device as "really easy to use. We sent canisters of nasal glucagon home with patients and asked their caregivers to be ready to administer if the person should have an episode of severe or moderate hypoglycemia. They just have to put their fingers around it with their thumb at the button, and put the little device into the nose of someone when they are having hypoglycemia, and push."

Additionally, patients and caregivers completed a questionnaire on hypoglycemic episode symptoms, blood glucose, adverse events, and the ease-of-use.

Seaquist reported that mean blood glucose at hypoglycemic episodes onset was 47.9 mg/dL and increased to 112.8 mg/dL by 30 minutes and continued to rise with progressive time.

Twelve severe hypoglycemic episodes in seven patients were observed, all of which resolved and patients awoke or returned to normal status within 15 minutes. Nasal glucagon administration time was <30 seconds for most hypoglycemic episodes (70.4%) and was <2 minutes in nearly all (97.7%) hypoglycemic episodes.

The safety population included 74 patients who had a total of 179 hypoglycemic episodes. Seaquist noted that at least one adverse event was experienced by 87.8% of patients, with the most common events listed as nasal irritation (82.4%) and headache (54.1%).

The researchers found no serious drug-related adverse events and the majority of caregivers were satisfied or very satisfied with nasal glucagon after most hypoglycemic episodes (82.7%).

Nasal glucagon was developed by Locemia Solutions and will be marketed by Eli Lilly. The latter, which also makes injectable glucagon kits, has not released information on the drug price or when exactly it will be available for patients.

"I look forward to when it eventually gets to market. The company is working with the FDA ... we will have to see how long it takes but I can see it on the horizon," Sequist said.

Comment