Baqsimi (glucagon intranasal dry powder) / Amphastar - LARVOL DELTA

Transmucosal glucagon rapidly increases blood glucose concentration in healthy cats. (PubMed, J Feline Med Surg) - "Transmucosal glucagon administration is effective in raising BG with minimal side effects in healthy cats. Future studies are needed to quantify the efficacy and safety of transmucosal glucagon in diabetic cats, especially during hypoglycemic crises."

Clinical • Journal • Diabetes • Hypoglycemia • Metabolic Disorders

Population pharmacokinetics and pharmacodynamics of nasal glucagon in patients with type 1 or 2 diabetes. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "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."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders

A Study of Nasal Glucagon in Children with Insulin Dependent Diabetes (clinicaltrialsregister.eu) - P1 | N=6 | Sponsor: Eli Lilly and Company

New P1 trial • Diabetes • Metabolic Disorders • Pediatrics • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials. (PubMed, J Endocr Soc) - P1, P3 | "This study demonstrated lower rebound hyperglycemia risk after NG treatment compared with IG. NCT03421379, NCT03339453, NCT01994746."

Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Glucagon: Delivery Advancements for Hypoglycemia Management. (PubMed, Int J Pharm) - "Recent developments include non-injectable methods like BAQSIMI® (Nasal glucagon) offers a user-friendly option, but stability, bioavailability, and rapid onset remain formulation hurdles...The synergy of patent innovation and clinical validation offers a glimpse into the transformative potential of glucagon delivery yet underscores the intricate path toward widespread adoption and improved diabetes care. Finally, this review will help the formulation scientist, clinicians, healthcare providers, and patient to manage hypoglycemia using glucagon."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders

RescuiNGkids: A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Systematic Literature Review and Indirect Treatment Comparison of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia. (PubMed, Diabetes Ther) - "Baqsimi, Gvoke and Zegalogue had comparable high proportions of treatment success in reversing insulin-induced hypoglycemia. Baqsimi achieved a lower mean maximum blood glucose value, which may have implications for the re-establishment of euglycemia. These findings may help support patients, caregivers and health care providers in their decision-making process when discussing various ready-to-use glucagon treatment options."

Clinical • Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Studying the IMPpact of nasal glucagon on real-Life Experiences of Severe hypoglycemia Treatment (SIMPLEST) in the German population (EASD 2023) - "Overall, 127 PwD currently or previously owned GlucaGen Hypokit, of which 77 used it to treat SH... Evaluation of risk of SH is an important factor for prescribing NG. The overall satisfaction with NG and the positive impact on QoL suggest that NG could improve PwD's everyday life related to SH management."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Emerging Adult and Caregiver Psychosocial Experiences with Severe Hypoglycemic Events and the Perceived Impact of Nasal Glucagon: A Cross-Sectional Study. (PubMed, Diabetes Ther) - "Participants reported improved confidence in other people's ability to help during severe hypoglycemic events since having nasal glucagon available. This suggests that nasal glucagon may help broaden the support network for young people with type 1 diabetes and their caregivers."

Journal • Observational data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

"$LLY $AMPH Lilly to Divest BAQSIMI to Amphastar https://t.co/QVLzOY4PO2 #trading #stocks" (@stock_titan)

Dose Rationale of Nasal Glucagon in Japanese Pediatric Patients with Diabetes Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation. (PubMed, Paediatr Drugs) - "This analysis suggests NG 3 mg has robust efficacy without serious safety concerns in Japanese pediatric patients with diabetes."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Pain • Pediatrics

Use of glucagon in severe hypoglycemia is scarce in most countries, and has not been expanded by new ready-to-use glucagons. (PubMed, Diabetol Metab Syndr) - "The aims of this study were to evaluate the use of glucagon in persons with type 1 diabetes in several countries, and to investigate if the availability of new ready-to-use glucagons (Baqsimi, Gvoke, Zegalogue, years 2019 to 2021) has expanded the overall use of glucagon...The use of glucagon (any type) remains low, approximately 1/10 of persons with type 1 diabetes. We conclude that use of glucagon is scarce in most countries, and so far has not been expanded by new ready-to-use glucagons such as the ones considered in this study."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Development of a Measure to Assess Attitudes Towards Nasal versus Autoinjector Glucagon Delivery Devices for Treatment of Severe Hypoglycemia. (PubMed, Diabetes Metab Syndr Obes) - "This study supports the validity and reliability of the GDAQ, which successfully conceptualizes attitudes towards devices for administering glucagon among different respondent groups. Use of the GDAQ can help guide the development and testing of new glucagon drug/device combinations."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia

100 years with insulin. Implementation of analogs and technology in our environment (ESPE 2022) - "Of the 6 pumps, they use lispro (4/6), aspartic (1/6) and another glulisine (1/6) Of the MDIs, as slow analogs NPH 0/65, detemir 12/65 (85% are <6 years), U100 10/65, U300 35/65 liraglutide 8/65...Of the MDIs, such as fast analogues è Actrapid 0/65, lispro 30/65 (1 U200 off labell per dose), aspartic 10/65, ultrafast (15/65) and glulisine 10/65 The indication has been for age, comfort, dose / need for stockings and a pen for this purpose and switch due to poor adjustment of the previous analog...There was no impediment by medical inspection in any prescription except in 1 case (belonging to another health area) with BAQSIMI Previous severe hypoglycemia with previous loss of consciousness in <5% of cases (0.03 patient / year cases)... We assume that this study may have some shortcomings due to the size of the sample, but our study demonstrates the implementation of the most modern analogs in the office, of measurement technology, but the need to advance in the..."

Diabetes • Metabolic Disorders • Pediatrics • Severe Hypoglycemia

Inhaled glucagon, a new well-accepted therapeutic tool in pediatrics (ESPE 2022) - "On 01/14/2021, the European Commission authorized the marketing of Baqsimi® 3 mg (nasal glucagon), a powder medicine, ready to be used, in the treatment of severe hypoglycemia in adults, adolescents and children over four years of age with diabetes mellitus...Previous use of GLUCAGEN hipoKIT... We assume that this study may have some shortcomings due to the size of the sample, but our study demonstrates the efficacy of inhaled glucagon in emergency situations in real life, its good tolerance and its excellent reception by families."

Clinical • Diabetes • Metabolic Disorders • Pain • Pediatrics • Severe Hypoglycemia

Nasal glucagon (Baqsimi®), new treatment for hypoglycaemic coma (PubMed, Rev Med Liege) - "Stimulation and real-life studies among caregivers, patients and acquaintances showed a preference for nasal glucagon because of its easy and quick use. The launch of nasal glucagon (Baqsimi®) offers new perspectives for the ambulatory emergency management of severe hypoglycaemia and hypoglycaemic coma with a special obvious advantage in children."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Diabetes • Epilepsy • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Indirect Treatment Comparison (ITC) of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia: Baqsimi, Gvoke, and Zegalogue (ADA 2022) - "Ten trials were included in the ITC, including 4 for Baqsimi, 3 for Gvoke, and 3 for Zegalogue. Baqsimi had comparable efficacy with Gvoke and with Zegalogue (Table), and all 3 treatments achieved high treatment success (>98%) in adults and children with diabetes. In adults, results from the combined T1D and T2D analysis were consistent with the T1D analysis, except a statistically significant faster time achieving treatment success observed for Baqsimi vs."

Metabolic Disorders • Severe Hypoglycemia

"Thank you to Justin Saunders with @LillyPad to train our @ACSchoolsTN nurses on Baqsimi (glucagon) nasal powder. #EveryStudentEveryDay" (@acschoolnurses)

People With Diabetes and Caregivers Prefer Rescue Glucagon Treatment With a Wider Storage Temperature Range and a Nasal Administration, When Efficacy is Similar: A Discrete Choice Experiment in Spain. (PubMed, J Diabetes Sci Technol) - "Participants favored NG over conventional IG as a rescue medication for severe hypoglycemia. This information may help decision-making by payers and treatment discussions between health care professionals and patients."

Journal • Diabetes • Metabolic Disorders • Pain • Severe Hypoglycemia

RescuiNGkids: A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Indirect treatment comparison of ready-to-use glucagon rescue treatments for severe hypoglycemia: nasal glucagon versus liquid stable glucagon (DDG 2022) - "NG and GRP had comparable efficacy in reversing insulin-induced hypoglycemia in adults with diabetes. NG had a mean max BG < 180 mg/dL, which may have implications for re-establishing euglycemia after severe hypoglycemia."

Diabetes • Metabolic Disorders • Severe Hypoglycemia

Cost of Severe Hypoglycemia and Budget Impact with Nasal Glucagon in Patients with Diabetes in Spain. (PubMed, Diabetes Ther) - "In Spain, the usability advantage of NG over IG translates to potential cost savings per SHE in three populations with insulin-treated diabetes, and the introduction of NG was associated with a lower budget impact versus IG in each group."

HEOR • Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Nasal Glucagon is Easier to Use, More Preferred, and Needs Less Effort to Administer Than Injectable Glucagon: User Perceptions of Glucagon Administration During Severe Hypoglycemia Simulation. (PubMed, Endocr Pract) - "Participants in this study considered NG easier, more preferred, required less effort for administration, and more intuitive to use than reconstitutable IG, irrespective of whether there was prior training. NG improves the potential for successful administration of glucagon, better preparedness, and increased adoption of glucagon for SH rescue."

Journal • Diabetes • Metabolic Disorders • Severe Hypoglycemia

Evaluation of the cost and medical resource use outcomes associated with nasal glucagon versus injectable glucagon for treatment of severe hypoglycemia in people with diabetes in Canada: a modelling analysis. (PubMed, J Med Econ) - "EMS call outs were project to be reduced by 45%, emergency room treatments by 52%, and inpatient stays by 13%. Use of nasal glucagon was associated with reduced direct, indirect and combined costs of CAD 1,249, CAD 460 and CAD 1,709 per severe hypoglycemic event, respectively, due to avoided EMS call outs and hospital costs, resulting from a higher proportion of successful administrations.ConclusionsWhen a patient with type 1 or type 2 diabetes is being treated for a severe hypoglycemic event when impaired consciousness precludes treatment with oral carbohydrate, use of nasal glucagon was projected to be dominant versus injectable glucagon in Canada reducing costs and use of medical services."

Journal • CNS Disorders • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Stimulation Test With Intranasal Glucagon for Corticotroph, Somatotroph and Antidiuretic Axes (clinicaltrials.gov) - P4; N=10; Completed; Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

New P4 trial • Endocrine Disorders