Baqsimi ® (glukagon näspulver)

För fullständig produktresumé för Baqsimi® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Baqsimi® (glukagon näspulver): Studie av användning i verkliga livet på vuxna

I en studie av användning i verkliga livet på vuxna resolverades 96,2 % av måttliga till allvarliga hypoglykemiska händelser inom 30 minuter efter administrering av glukagon näspulver.

Real-World Use Study in Adults 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 adults (aged 18 to 75 years) with T1DM in a real-world setting (home or work).1

Study Design

Participants and caregivers were trained to administer NG. 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 NG administration as determined by the caregivers.1

The study defined severe and moderate hypoglycemic events.

  • Severe hypoglycemic event: An event in which the adult with DM is clinically incapacitated and requires third-party assistance.

  • Moderate hypoglycemic event: An event in which the adult with DM shows signs and symptoms of neuroglycopenia with blood glucose at or near the time of treatment of ≤3.3 mmol/L (≤60 mg/dL).1

Seventy-four adults were included in the main safety analysis with a mean age of 46.2 years and a duration of T1DM of 26.3 years (Table 1).1

Table 1. Adult Real-World Use Study With NG: Baseline Demographics and Clinical Characteristics1

Parametera

N=74b

Age, y

46.2 (15.0)

DM duration, y

26.3 (13.6)

Participants using insulin pump, n (%)

39 (52.7)

Number of daily insulin injections, n

4.2 (0.87)

Daily insulin dose, units

49.5 (21.7)

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

0 - 30 days

16 (21.6)

31 - 90 days

13 (17.6)

91 - 180 days

9 (12.2)

181 days - 1 year

5 (6.8)

>1 year

24 (32.4)

Never

7 (9.5)

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

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

b The main safety analysis population included 74 adults (179 events) who experienced ≥1 hypoglycemic event and received ≥1 dose of NG.

Effectiveness Results

The effectiveness analysis included 69 adults who experienced 157 moderate or severe hypoglycemic events.1

Sixty-six (95.7%) adults awakened or returned to normal status within 30 minutes after NG administration in at least 1 evaluable hypoglycemic event.1

One hundred and fifty-one (96.2%) of the moderate or severe hypoglycemic events resolved with awakening or returning to normal status within 30 minutes after NG administration.1

Five of the 6 hypoglycemic events that did not resolve within 30 minutes achieved recovery within 30 to 45 minutes. One adult reported a persistent headache, which kept them from reporting a return to normal status.1

The mean blood glucose level was

  • 2.7 mmol/L (47.9 mg/dL) at the time of NG administration, and 

  • 4.7 mmol/L (84.4 mg/dL) at 15 minutes after NG administration.1

Twelve severe hypoglycemic events were reported in 7 adults. At the time of NG administration, the blood glucose levels ranged from 1.6 mmol/L to 3.3 mmol/L (29 mg/dL to 60 mg/dL). Status returned to normal or patients awakened within 15 minutes of NG administration in all cases including those who were unconscious or had convulsions.1

No additional emergency health services 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 87.8% of participants reporting at least 1 adverse reaction or symptom (Table 2). Most of the adverse reactions or symptoms were of low to moderate severity. The most commonly reported adverse reaction or symptom was nasal irritation, with it resolving in less than 1 hour in most participants.1

Table 2. Adult Real-World Use Study: Most Common Adverse Reactions or Symptoms Reported With NG Through Questionnaires1

Adverse Reaction, n (%) 

Total number of hypoglycemic events 
N=179
a

Nasal irritation

105 (58.7) 

Headache

58 (32.4) 

Nausea

24 (13.4) 

Vomiting

13 (7.3) 

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

a The main safety analysis included 74 adults who experienced a total of 179 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 70.4% of hypoglycemic events, within 1 minute in 92.7% of hypoglycemic events, and within 2 minutes in 97.7% of hypoglycemic events. Overall satisfaction for use of NG was 94.4% (Table 3).1

Table 3. Adult Real-World Use Study: Ease of Use of NG Based on Assessment by Caregivers1

Ease of Use and Caregiver Satisfaction Categories

% of Caregiversa

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

97.7

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

96.6

Ease of administering NG (very easy, easy, relatively easy)

89.4

Overall satisfaction (very satisfied, satisfied, relatively satisfied)

94.4

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

a The main safety analysis population included 74 adults (179 events) who experienced ≥1 hypoglycemic event and received ≥1 dose of NG.

References

1. Seaquist ER, Dulude H, Zhang XM, et al. 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. Diabetes Obes Metab. 2018;20(5):1316-1320. https://doi.org/10.1111/dom.13278

Glossary

DM = diabetes mellitus

NG = nasal glucagon (glucagon nasal powder)

T1DM = type 1 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M07 24


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss