Adult Clinical Trials
BAQSIMI demonstrated noninferiority to glucagon for injection in treating insulin-induced hypoglycemia in adults1,*
Treatment Success† for BAQSIMI and glucagon for injection
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Two bar graphs show measures of treatment success for BAQSIMI (3 milligrams) and for glucagon for injection (1 milligram). In Study 1, 100 percent of patients treated with BAQSIMI and 100 percent of patients treated with glucagon for injection achieved treatment success as defined in the study. In Study 2, 98.8 percent of patients treated with BAQSIMI and 100 percent of patients treated with glucagon for injection achieved treatment success as defined in the study.
*In study 1, the mean nadir blood glucose was 54.5 mg/dL for BAQSIMI and 55.8 mg/dL for glucagon for injection. In study 2, the mean nadir blood glucose was 44.2 mg/dL for BAQSIMI and 47.2 mg/dL for glucagon for injection.
†Treatment success was defined as an increase in plasma glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes of receiving the study glucagon.
Study Design
- Two randomized, multicenter, open-label, 2-period crossover trials compared a 3 mg dose of nasally administered BAQSIMI to a 1 mg dose of glucagon for injection (IM) for treatment of insulin-induced hypoglycemia.
- Study 1 included 70 adult patients with type 1 diabetes; 66 patients were included in the efficacy analysis. Study 2 included 83 adult patients with type 1 or type 2 diabetes; 80 patients were included in the efficacy analysis.
- Primary efficacy measure was the proportion of patients achieving treatment success.
Mean plasma glucose concentrations over time with BAQSIMI and glucagon for injection1
Study 1 – Mean Plasma Glucose Concentrations
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In BAQSIMI-treated patients (n equals 66), mean time to treatment success was 11.6 minutes, with maximum plasma glucose concentration of 190.8 milligrams per deciliter observed at 90 minutes.
In patients treated with glucagon for injection (n equals 66), time to treatment success was 9.9 minutes, with maximum plasma glucose of 219.5 milligrams per deciliter observed at 90 minutes.
Across studies, the mean time to treatment success was a range of 11.6 to 15.9 minutes.
Study Design
- A randomized, multicenter, open-label, 2-period crossover trial for efficacy analysis compared a 3 mg dose of nasally administered BAQSIMI to a 1 mg dose of glucagon for injection (IM) for treatment of insulin-induced hypoglycemia in 66 adult patients with type 1 diabetes.
- Treatment success was defined as an increase in plasma glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes of receiving the study glucagon.
- Plasma glucose concentrations were measured prior to administration of glucagon (t=0, glucose concentration <60 mg/dL) and at various time intervals until 90 minutes after administration.2
SELECT IMPORTANT SAFETY INFORMATION
Contraindications
BAQSIMI is contraindicated in patients with pheochromocytoma because of risk of substantial increase in blood pressure, insulinoma because of risk of hypoglycemia, and known hypersensitivity to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.
Warnings and Precautions
BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.
Common cold with nasal congestion did not impact absorption of BAQSIMI3
Glucose Concentrations Over Time Following BAQSIMI Administration
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Following BAQSIMI administration to subjects who had a common cold (with nasal congestion) and had received a decongestant, plasma glucose reached maximum concentration of 158 milligrams per deciliter at 42 minutes. Subjects with cold symptoms who received BAQSIMI reached maximum glucose concentration of 144 milligrams per deciliter after 30 minutes. Subjects without cold symptoms who received BAQSIMI reached maximum glucose concentration of 139 milligrams per deciliter after 36 minutes.
Study Design3
- A randomized, single-center, open-label, repeated-measures, parallel-design, phase I study examining the safety and PK/PD of a single BAQSIMI 3 mg dose in otherwise healthy adult participants with nasal congestion resulting from common cold.
- Adult participants in cohort 1 (n=18) received 2 doses of BAQSIMI 3 mg: one while experiencing nasal congestion and another after recovery from cold symptoms.
- Adult participants in cohort 2 (n=18), who also had colds with nasal congestion, received a single dose of BAQSIMI 3 mg 2 hours after treatment with the decongestant oxymetazoline.
- Blood glucagon and glucose concentrations were measured before and at various time intervals until 180 minutes after BAQSIMI administration.
References:
- Baqsimi. Prescribing Information. Amphastar Pharmaceuticals, Inc.
- Suico JG, Hövelmann U, Zhang S, Shen T, Bergman B, Sherr J, Zijlstra E, Frier BM, Plum-Mörschel L. Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. Diabetes Ther. 2020 Jul;11(7):1591-1603. doi: 10.1007/s13300-020-00845-7.
- Guzman CB, Dulude H, Piché C, et al. Effects of common cold and concomitant administration of nasal decongestant on the pharmacokinetics and pharmacodynamics of nasal glucagon in otherwise healthy participants: a randomized clinical trial. Diabetes Obes Metab. 2018;20(3):646-653.