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Intranasal Glucagon for Severe Hypoglycemia in Type 1 Diabetes Patients

The therapy, aimed at caregivers, could provide a better treatment choice and easier administration to a patient…

 

Insulin therapy is the gold standard for patients with Type 1 diabetes, and about 30% of type 2 diabetic patients require insulin therapy. This therapy is used to control blood glucose and prevent long-term vascular complications; however, severe hypoglycemia is one risk associated with the use of insulin. Currently, the main treatment of choice for severe hypoglycemia in the community setting is SC or IM injection of glucagon.

Challenges, however, exist with injected glucagon for severe hypoglycemia. First and foremost, glucagon itself is unstable in a liquid state; therefore, it requires a caregiver to reconstitute the product prior to administration. The caregiver is required to perform all the necessary steps under an emergency situation to inject the hypoglycemic patient. These required steps can often result in suboptimal outcomes in delayed administration, errors in treatment, and delays in receiving medical assistance. In a study done on parents of T1D patients, who have been trained on the use of a glucagon kit, 69% had difficulties in handling the kit. In the same study, an average of 2½ minutes was required to complete the administration of the glucagon (the minutes ranged from 30 seconds to >12 minutes), 6% aborted the injection completely, and 4% injected only air or diluent. From this study, we can see that an alternative delivery system would be desirable.

A novel treatment by Locemia Solution, AMG504-1, is being tested and developed as an alternative to glucagon injections. AMG504-1 is a new intranasal product that contains a dry powder glucagon with a phospholipid (absorption enhancer) and cyclodextrin (bulking agent). The formulation is contained in a single-use nasal dosing device and does not require any reconstitution or steps prior to its use. The caregiver only needs to simply insert the tip of the device into 1 nostril and fully depress the plunger.

Data generated from the AMG504-1 study showed that it was safe and effective in healthy volunteers. The onset of absorption from nasal mucosa was within minutes, and plasma glucagon levels were dose related. Compared to SC administration, IN glucagon had lower levels of plasma glucagon; however, the glucose response was similar between 2 mg IN dose and a 1 mg SC dose of glucagon. Besides the easy use of IN glucagon, AMG504-1 has a relatively better safety profile. In the study, some patients had mild to moderate nasal/ocular irritation with no patient reporting any gastrointestinal adverse events; with SC glucagon, however, 40% experienced nausea and 20% had vomiting.

The availability of this product on the market would be beneficial to hypoglycemic patients. In a survey of >100 T1D patients, 67% of patients said they would prefer an IN administration of glucagon were it available, and 82% believed that their caregivers would prefer an IN route in emergency situations. Additional research is still needed to evaluate the use of AMG504-1, especially in the ability of the intended users, the caregivers, and its efficacy in treating patients with hypoglycemia. Another area of evaluation would be its effect in patients with nasal congestion.

Practice Pearls:

  • Novel intranasal glucagon for treatment of severe hypoglycemia.
  • Potentially better treatment choice and utilization for the intended users, caregivers.
  • Better safety profile compared to SC glucagon: nasal/ocular irritation compared to nausea and vomiting.

Pontiroli, AE. Intranasal Glucagon: A Promising Approach for Treatment of Severe Hypoglycemia. Journal of Diabetes Science and Technology. 2015; 9(1): 38-43