Prospective study evaluates use of nasal glucagon for treatment of moderate to severe hypoglycemia in adults with type 2 diabetes.
New data was recently published in Pediatric Diabetes from a study designed to evaluate the effectiveness and ease of use of Eli Lilly and Company’s investigational nasal glucagon rescue therapy, a ready-to-use nasal dry powder spray, in treating moderate or severe hypoglycemic events in children and adolescents with type 1 diabetes in a real-world setting. (Study title: A phase 3 multicenter, open-label, prospective study designed to evaluate the effectiveness and ease of use of nasal glucagon in the treatment of moderate and severe hypoglycemia in children and adolescents with type 1 diabetes in the home or school setting)
The present multicentre, open‐label, prospective, phase III study was designed to evaluate the effectiveness and ease of use of nasal glucagon (NG) in the treatment of moderate to severe hypoglycemia events (HE) in adults with type 1 diabetes (T1D). Patients and caregivers were taught how to use NG (3 mg) to treat moderate/severe HEs, record the time taken to awaken or return to normal status, and measure blood glucose (BG) levels over time. Questionnaires were used to collect information about adverse events and ease of use of NG. In the efficacy analysis population, 69 patients experienced 157 HEs. In 95.7% of patients, HEs resolved within 30 minutes of NG administration. In all 12 severe HEs, patients awakened or returned to normal status within 15 minutes of NG administration without additional external medical help. Most caregivers reported that NG was easy to use. Most adverse events were local and of low to moderate severity. In this study, a single, 3 mg dose of NG demonstrated real-life effectiveness in treating moderate and severe HEs in adults with T1D. NG was well tolerated and easy to use.
|Nasal Glucagon||Injection Kit||Nasal Glucagon||Injection Kit|
|% Who gave correct dose||94%||13%||93%||0%|
|Average time to dose given||16 seconds||1 minute,
|26 seconds||2 minutes, 24 seconds|
There’s no question that current glucagon injection kits are very difficult to use correctly, but these data show even the trained caregivers of people with diabetes find them hard to use: 50% of diabetes caregivers (8 of 16) failed to deliver any glucagon at all with the injection kit vs. just 6% (1 of 15) with intranasal. This outcome is the most significant – if no glucagon is delivered at all, there is clearly a major issue with the delivery method.
Caregivers were trained to administer NG (3 mg) to the child/adolescent with T1D during spontaneous, symptomatic moderate or severe hypoglycemic events, observe treatment response (defined as awakening or returning to normal status within 30 minutes), and measure blood glucose (BG) levels every 15 minutes in the home or school setting. After receiving nasal glucagon, participants returned to a normal state within 30 minutes in 100 percent of moderate hypoglycemic events. No severe hypoglycemic events resulting in seizures or coma were reported. Data regarding adverse events and ease of use were solicited using questionnaires.
The results showed that the study included 14 patients who experienced 33 moderate hypoglycemic events with neuroglycopenic symptoms and BG level ≤70 mg/dL. Patients returned to normal status within 30 minutes of NG administration in all 33 events. Mean BG levels increased from 55.5 mg/dL (range 42‐70 mg/dL) at baseline to 113.7 mg/dL (range 79‐173 mg/dL) within 15 minutes of NG administration. In most hypoglycemic events (93.9%), caregivers reported that NG administration was easy or very easy; they could administer NG within 30 seconds in 60.6% of events. There were no serious adverse events.
Results from the study included:
- In more than half of the hypoglycemic events (54.5%), patients returned to normal status within 10 minutes of nasal glucagon administration.
- Caregivers reported that the administration of nasal glucagon was easy or very easy in 93.9 percent of hypoglycemic events.
- Within the first 30 minutes of nasal glucagon administration (primary outcome of the study), no additional emergency health services, oral carbohydrates, or injectable glucagon were required.
- The most common (>25%) adverse events solicited through questionnaires were nasal discomfort (92.9%), watery eyes (85.7%), headache (71.4%), runny nose (64.3%), nasal congestion (50.0%), sneezing (50.0%), redness of eyes (42.9%), nausea (28.6%) and nasal itching (28.6%).
From the final results, it was concluded that a single 3 mg dose of NG was effective in treating moderate, symptomatic, hypoglycemic events in children and adolescents with T1D in a real-world setting. It was easy to use and reasonably well tolerated. NG shows promise as an effective, needle-free, and user-friendly alternative to injectable glucagon.
- The investigational nasal glucagon is not yet approved for use in the US or other markets
- In 54.5% of the time half of the patents returned to normal status within 10 minutes
- The use of inhaled glucagon will save time and prevent many of the errors when using injectable glucagon.
- Lilly plans to submit a new drug application (NDA) to the FDA in the first half of 2018, which will include the current study.
Correction, April 30, 2018: This article originally stated that the nasal glucagon had already been approved in Europe, when in fact it is still investigational and has not been approved in Europe or other global markets. We apologize for the error.