Pediatric Clinical Trials
Following insulin-induced glucose reduction, 100% of patients achieved treatment success with BAQSIMI1,*
Treatment Success† for BAQSIMI and glucagon for injection
View Description
This bar graph shows measures of treatment success for BAQSIMI (3 milligrams) and for glucagon for injection (1 milligram) in a study of pediatric patients. One hundred percent of pediatric patients treated with BAQSIMI and 100 percent of pediatric patients treated with glucagon for injection achieved treatment success as defined in the study.
*The mean nadir blood glucose across different age cohorts was 67-73 mg/dL for BAQSIMI and 69-72 mg/dL for glucagon for injection.2
†Treatment success was defined as an increase in plasma glucose of ≥20 mg/dL from the nadir glucose concentration within 30 minutes of glucagon dosing.
Study Design
- A randomized, multicenter study that evaluated the PK/PD, safety, and efficacy of BAQSIMI compared with glucagon for injection in children and adolescents aged 4 to <17 years with type 1 diabetes (n=48) divided into 3 cohorts.2
- Young children (ages 4 to <8 years, n=18) and children (ages 8 to <12 years, n=18) were randomized 2:1 to receive either BAQSIMI 2 mg or 3 mg at visit 1 and the alternative BAQSIMI dose at visit 2, or weight-based glucagon for injection at a single study visit. Adolescents (ages 12 to <17, n=12) were randomized 1:1 to receive BAQSIMI 3 mg or glucagon for injection 1 mg with crossover to alternate glucagon at dosing visit 2. Insulin was used to reduce blood glucose levels, and glucagon was administered after glucose reached <80 mg/dL.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.
Mean plasma glucose concentrations over time with BAQSIMI2
Mean Glucose Concentration Over Time With BAQSIMI 3 mg in Ages 4 to <17 Years Old
View Description
This line graph shows mean plasma glucose concentrations from 0 to 90 minutes for children aged 4 to <8, aged 8 to <12, and aged 12 to <17 who were treated with BAQSIMI 3 mg (n equals 12). Children aged 4 to <8 experienced mean time to treatment success of 10.8 minutes, with mean maximum glucose concentration levels of 208 milligrams per deciliter. Children aged 8 to <12 experienced mean time to treatment success of 11.3 minutes, with mean maximum glucose concentration levels of 206 milligrams per deciliter. Children aged 12 to <17 experienced mean time to treatment success of 14.2 minutes, with mean maximum glucose concentration levels of 178 milligrams per deciliter.
Compare BAQSIMI to glucagon for injection for cohorts
Mean Glucose Concentration Over Time
Young Children 4 to <8 Years Old
View description
In children aged 4 to <8, those treated with BAQSIMI 3 mg (n equals 12) experienced mean time to treatment success of 10.8 minutes, with a mean maximum glucose concentration level of 208 milligrams per deciliter. Those treated with glucagon for injection 1 mg (n equals 6) experienced mean time to treatment success of 10.8 minutes, with a mean maximum glucose concentration level of 211 milligrams per deciliter.
Mean Glucose Concentration Over Time
Children 8 to <12 Years Old
View description
In children aged 8 to <12, those treated with BAQSIMI 3 mg (n equals 12) experienced mean time to treatment success of 11.3 minutes, with a mean maximum glucose concentration level of 206 milligrams per deciliter. Those treated with glucagon for injection 1 mg (n equals 6) experienced a mean time to treatment success of 12.5 minutes, with a mean maximum glucose concentration level of 205 milligrams per deciliter.
Mean Glucose Concentration Over Time
Adolescents 12 to <17 Years Old
View description
In children aged 12 to <17, those treated with BAQSIMI 3 mg (n equals 12) experienced a mean time to treatment success of 14.2 minutes, with a mean maximum glucose concentration level of 178 milligrams per deciliter. Those treated with glucagon for injection 1 mg (n equals 6) experienced a mean time to treatment success of 12.5 minutes with glucagon, with a maximum glucose concentration level of 194 milligrams per deciliter.
Mean Time to Treatment Success (minutes)
| Age Group | BAQSIMI 3mg n=12 | IMG* n=6 |
|---|---|---|
| Young Children (4 to <8 years old) | 10.8 | 10.8 |
| Children (8 to <12 years old) | 11.3 | 12.5 |
| Age Group | BAQSIMI 3mg n=12 | IMG* n=12 |
|---|---|---|
| Adolescents (12 to <17 years old) | 14.2 | 12.5 |
*0.5 mg or 1 mg of IMG (based upon body weight)
Study Design2
- A randomized, multicenter study that evaluated the PK/PD, safety, and efficacy of BAQSIMI compared with glucagon for injection in children and adolescents aged 4 to <17 years with type 1 diabetes (n=48) divided into 3 cohorts.
- Young children (ages 4 to <8 years, n=18) and children (ages 8 to <12 years, n=18) were randomized 2:1 to receive either BAQSIMI 2 mg or 3 mg at visit 1 and the alternative BAQSIMI dose at visit 2; or weight-based glucagon for injection at a single study visit. Adolescents (ages 12 to <17 years, n=12) were randomized 1:1 to receive BAQSIMI 3 mg or glucagon for injection 1 mg with crossover to alternate glucagon at dosing visit 2. Insulin was used to reduce blood glucose levels, and glucagon was administered after glucose reached <80 mg/dL.
- Treatment success was defined as an increase in plasma glucose of ≥20 mg/dL from the nadir glucose concentration within 30 minutes of glucagon dosing.
Common cold with nasal congestion did not impact absorption of BAQSIMI3
Glucose Concentrations Over Time Following BAQSIMI Administration
View Description
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.
