Baqsimi ® (glukagon näspulver)

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Baqsimi® (glukagon näspulver): Studie av användning i verkliga livet inom pediatrik

I en studie av användning i verkliga livet inom pediatrik resolverades 100 % av måttliga hypoglykemiska händelser inom 30 minuter efter administrering av glukagon näspulver.

Real-World Use Study in Children and Adolescents With Diabetes

A phase 3, open-label, multicenter, single-arm study evaluated the effectiveness and ease of use of NG 3 mg in the treatment of moderate or severe hypoglycemic events in children and adolescents (aged 4 to <18 years) with T1DM in a real-world use setting (home or school).1

Study Design

Principal caregivers were trained to administer Nasal Glucagon and to assess the return to normal status. The primary outcome measure was the proportion of participants and proportion of events in which awakening or returning to normal status occurred within 30 minutes of Nasal Glucagon administration as determined by the caregivers.1

The study defined severe and moderate hypoglycemic events.

  • Severe hypoglycemic event: An event associated with severe neuroglycopenia often resulting in coma or seizure and requiring parenteral therapy (glucagon or IV glucose).

  • Moderate hypoglycemic event: An event in which the child with DM shows signs and symptoms of neuroglycopenia with a blood glucose at or near the time of treatment of ≤3.9 mmol/L (≤70 mg/dL).1

Fourteen children were included in the main efficacy and safety analysis with a mean age of 10.2 years and a duration of T1DM of 6.3 years ( ).1

Table 1. Pediatric Real-World Use Study With Nasal Glucagon: Baseline Demographics and Clinical Characteristics1

Parametera

N=14

Age, y

10.2 (3.6)

DM duration, y

6.3 (3.5)

Participants using insulin pump, n (%)

10 (71.4)

Number of daily insulin injections, n

5.8 (1.7)

Daily insulin dose, units

42.3 (31.2)

Participants who experienced severe hypoglycemic event in past year, n (%)

3 (21.4)

Time since most recent severe hypoglycemic event, n (%)

0 - 30 days

2 (14.3)

31 - 90 days

1 (7.1)

>365 days

5 (35.7)

Never

6 (42.9)

Abbreviations: DM = diabetes mellitus; NG = nasal glucagon (glucagon nasal powder).

a All values are mean (SD) unless otherwise stated.

Effectiveness Results

Fourteen children experienced 33 moderate hypoglycemic events. There were no severe hypoglycemic events.1

All 33 (100%) moderate hypoglycemic events resolved with participants returning to normal status within 30 minutes after Nasal Glucagon administration. Eighteen (54.5%) participants returned to normal status within 10 minutes after Nasal Glucagon administration.1

The mean blood glucose level was

  • 3.1 mmol/L (55.5 mg/dL) at the time of Nasal Glucagon administration

  • >3.9 mmol/L (>70 mg/dL) at 15 minutes after Nasal Glucagon administration, and

  • continued to increase over 45 minutes.1

No additional emergency health services, oral carbohydrates, or injectable glucagon was required for the participants to return to normal status.1

Safety Results

Adverse reactions or symptoms were solicited through a questionnaire, with 100% of participants reporting at least 1 adverse reaction or symptom ( ). Approximately 60% of the adverse reactions or symptoms resolved in less than 1 hour and were of low to moderate severity.1

Table 2. Pediatric Real-World Use Study: Most Common Adverse Reactions or Symptoms Reported With Nasal Glucagon Through Questionnaires1

Adverse Reaction, n (%) 

Total number of hypoglycemic events
N=33
a

Nasal discomfort 

28 (84.8) 

Headache 

18 (54.5) 

Nausea 

6 (18.2) 

Vomiting 

1 (3.0) 

Abbreviation: NG = nasal glucagon (glucagon nasal powder).

a The main safety analysis included 14 children who experienced a total of 33 moderate hypoglycemic events. There were no severe hypoglycemic events.

Ease of Use and Caregiver Satisfaction Questionnaire

A questionnaire was completed by caregivers to assess ease of use and caregiver satisfaction. Caregivers were able to administer NG within 30 seconds in 60.6% of hypoglycemic events and within 2 minutes in 100% of hypoglycemic events. Overall satisfaction for use of Nasal Glucagon was 93.9% ( ).1

Table 3. Pediatric Real-World Use Study: Ease of Use of Nasal Glucagon Based on Assessment by Caregivers1

Ease of Use and Caregiver Satisfaction Categories

% of Caregivers

Time taken to administer NG (<30 sec, 30 to <60 sec, 1 to <2 min)

100.0

Understanding NG kit instructions (very easy, easy, relatively easy)

87.9

Ease of administering NG (very easy, easy)

93.9

Overall satisfaction (very satisfied, satisfied, relatively satisfied)

93.9

Abbreviation: NG = nasal glucagon (glucagon nasal powder).

References

1. Deeb LC, Dulude H, Guzman CB, et al. A phase 3 multicenter, open-label, prospective study designed to evaluate the effectiveness and ease of use of nasal glucagon in the treatment of moderate and severe hypoglycemia in children and adolescents with type 1 diabetes in the home or school setting. Pediatr Diabetes. 2018;19(5):1007-1013. https://doi.org/10.1111/pedi.12668

Glossary

DM = diabetes mellitus

IV = intravenous

NG = nasal glucagon (glucagon nasal powder)

T1DM = type 1 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M07 24


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