Intranasal Glucagon

Pontiroli, Antonio E.

doi:10.1177/1932296814557518

Cited by 34 publications

(14 citation statements)

References 35 publications

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“…Injectable glucagon has been the treatment of choice for hypoglycaemia, and its efficacy is well established1; however, injectable glucagon requires reconstitution and injection. In contrast, NG is needle‐free and ready‐to‐use, and a single 3‐mg dose can be used in both adult and paediatric patients independent of body weight 14.…”

Section: Discussionmentioning

confidence: 99%

“…Severe hypoglycaemia is a serious and potentially life‐threatening complication of insulin therapy 1, 2. Patients with type 1 diabetes (T1D) experience ~2 symptomatic hypoglycaemic events (HEs)/week and 1 severe HE/year 2, 3.…”

Section: Introductionmentioning

confidence: 99%

“…Patients with type 1 diabetes (T1D) experience ~2 symptomatic hypoglycaemic events (HEs)/week and 1 severe HE/year 2, 3. Fear of hypoglycaemia is a major barrier to the achievement of glycaemic targets in people with T1D 1, 4. Carbohydrate ingestion may not be possible in severe hypoglycaemia where the person may be unconscious or having a seizure 5.…”

Section: Introductionmentioning

confidence: 99%

“…In this scenario, caregivers can either inject glucagon or wait for professional help. The currently available glucagon kits require reconstitution prior to administration 1, 6. Nasal glucagon (NG), a needle‐free, single‐use, compact, portable, drug‐device combination consisting of 3 mg dry glucagon powder that does not require reconstitution, is currently under development as a rescue medication for severe hypoglycaemia 1.…”

Section: Introductionmentioning

confidence: 99%

“…The currently available glucagon kits require reconstitution prior to administration 1, 6. Nasal glucagon (NG), a needle‐free, single‐use, compact, portable, drug‐device combination consisting of 3 mg dry glucagon powder that does not require reconstitution, is currently under development as a rescue medication for severe hypoglycaemia 1. NG (3 mg) produced a rapid increase in blood glucose (BG) levels and was non‐inferior to intramuscular glucagon (1 mg) in a previous study in adults with insulin‐induced hypoglycaemia 5.…”

Section: Introductionmentioning

confidence: 99%

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Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real‐world setting

Seaquist

Dulude²,

Zhang

et al. 2018

Diabetes Obesity Metabolism

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In the present multicentre, open‐label, prospective, phase III study, we evaluated the real‐world effectiveness and ease of use of nasal glucagon (NG) in the treatment of moderate/severe hypoglycaemic events (HEs) 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% patients, HEs resolved within 30 minutes of NG administration. In all the 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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real‐world setting

Seaquist

Dulude²,

Zhang

et al. 2018

Diabetes Obesity Metabolism

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Population pharmacokinetics and pharmacodynamics of nasal glucagon in patients with type 1 or 2 diabetes

James,

Shen,

Geiser

et al. 2024

CPT Pharmacom & Syst Pharma

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The objective was to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of glucagon after injectable or nasal administration and confirm the appropriate therapeutic dose of nasal glucagon (NG) for adult patients. Six clinical studies with PK and five clinical studies with PD (glucose) data were included in the analysis. Doses ranging from 0.5 to 6 mg NG, and 0.5 to 1 mg injectable glucagon were studied. A total of 6284 glucagon and 7130 glucose concentrations from 265 individuals (patients and healthy participants) were available. Population PK/PD modeling was performed using NONMEM. Glucagon exposure and glucose response were simulated for patients administered various doses of NG to confirm the optimal dose. Glucagon PK was well‐described with a single compartment disposition with first‐order absorption and elimination processes. Bioavailability of NG relative to injectable glucagon was 16%. Exposure–response modeling revealed that lower baseline glucose was associated with higher maximum drug effect. The carry‐over effect from prior insulin administration was incorporated into the model through a time‐dependent increase in elimination rate of glucose. Simulations showed that more than 99% of hypoglycemic adult patients would experience treatment success, defined as an increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from nadir within 30 min after administration of NG 3 mg. The population PK/PD model adequately described the PK and PD profiles of glucagon after nasal administration. Modeling and simulations confirmed that NG 3 mg is the most appropriate dose for rescue treatment during hypoglycemia emergencies.

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Absorption of Biotechnology-Derived Biologics Drug Products

Stratford

2021

The ADME Encyclopedia

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Intranasal Glucagon

Cited by 34 publications

References 35 publications

Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real‐world setting

Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real‐world setting

Population pharmacokinetics and pharmacodynamics of nasal glucagon in patients with type 1 or 2 diabetes

Absorption of Biotechnology-Derived Biologics Drug Products

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