Baqsimi ® (glukagon näspulver)

För fullständig produktresumé för Baqsimi® se FASS.

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Baqsimi® (glukagon näspulver): Användning hos patienter med typ 2-diabetes

Alla 5 deltagare med T2DM inkluderade i den primära analysen i en av de pivotala vuxenstudierna uppnådde behandlingsframgång med både glukagon näspulver och IM-glukagon. Inga allvarliga biverkningar rapporterades bland dessa patienter.

Detailed Information

A randomized, multicenter, open-label, 2-period, crossover study evaluated NG 3 mg compared with injectable glucagon 1 mg administered IM as treatment for insulin-induced hypoglycemia in adults with T1DM or T2DM.1,2

Study Design

The primary outcome was the proportion of participants achieving treatment success within 30 minutes after receiving study glucagon without receiving additional interventions to increase the BG concentration.1,2

Treatment success was defined as an

  • increase in BG to greater than or equal to 3.9 mmol/L (70 mg/dL), or

  • increase in BG of greater than or equal to 1.1 mmol/L (20 mg/dL) above the BG nadir glucose concentration.1,2

The BG nadir concentration was defined as the minimum BG concentration at the time of, or within 10 minutes after glucagon administration.1,2

This study enrolled 83 adults between 18 and <65 years of age.1,2

Six adults had T2DM with

  • a mean age of 47.8 years

  • a mean DM duration of 18.8 years, and

  • 4 (67%) being female.1

Efficacy Results

The combined primary analysis cohort included all participants with T1DM and T2DM who received both doses of study drug with eligible BG and glucagon concentrations. One participant in the T2DM group was excluded due to high BG nadir, ≥3.9 mmol/L (≥70 mg/dL). All the other 5 (100%) participants with T2DM included in the analysis achieved treatment success within 30 minutes after receiving study glucagon (Table 1).1

The safety cohort consisted of all participants with T2DM who were randomized and received ≥1 dose of the study drug and included all 6 participants.1

Table 1. Treatment Outcome and Blood Glucose Parameters in Participants With T2DM Included in the Safety Cohorta1

T2DM Participants

Glucagon, NG/IM

Success, Yes/No

Glucose at t=0b,  mmol/L (mg/dL)

Nadir Glucose, mmol/L (mg/dL)

Time Point (min) When BG ≥3.9 mmol/L (≥70 mg/dL)

Time Point (min) When BG Increased 
≥1.1 mmol/L (≥20 mg/dL) From Nadir

1c

NG

yes

4.1 (73)

3.7 (66)

0

20

IM

yes

4.2 (75)

4.1 (74)

0

15

2

NG

yes

3.1 (56)

2.8 (51)

10

10

IM

yes

2.4 (44)

2.4 (44)

10

10

3

NG

yes

3.0 (54)

3.0 (54)

10

15

IM

yes

3.2 (57)

3.2 (57)

10

10

4

NG

yes

3.3 (59)

3.3 (59)

10

15

IM

yes

4.4 (62)

3.4 (62)

5

15

5

NG

yes

3.7 (67)

3.3 (60)

10

15

IM

yes

2.6 (47)

2.6 (47)

15

15

6

NG

yes

2.6 (46)

2.4 (44)

20

15

IM

yes

2.9 (53)

2.9 (52)

10

10

Abbreviations: BG = blood glucose; IM = intramuscular; NG = nasal glucagon (glucagon nasal powder); T2DM = type 2 diabetes mellitus.

a The safety cohort consisted of all participants with T2DM who were randomized and received ≥1 dose of the study drug.

b Glucose at t=0 is the BG at the time of glucagon administration.

c The combined primary analysis cohort included all participants with T1DM and T2DM who received both doses of study drug with eligible glucose and glucagon concentrations. This participant was excluded due to high nadir glucose, ≥3.9 mmol/L (≥70 mg/dL).

Safety Results

In the participants with T2DM, there were 4 spontaneously reported adverse reactions in 3 participants in the NG treatment group and 3 spontaneously reported adverse reactions in the IM treatment group (Table 2).1

Table 2. Spontaneously Reported Adverse Reactions by Treatment Arm in Participants With T2DM Included in the Safety Cohorta1

Adverse Reaction, number of events

NG 3 mg
N=6

IM Glucagon
N=6

Nausea

1

1

Nasal congestion

1

0

Weakness/fatigue

1

2

Pruritus

1

0

Abbreviations: IM = intramuscular; NG = nasal glucagon (glucagon nasal powder); T2DM = type 2 diabetes mellitus.

a The safety cohort consisted of all participants with T2DM who were randomized and received ≥1 dose of the study drug.

No serious adverse reactions were reported in any participants with T1DM or T2DM in either treatment group.1

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Rickels MR, Ruedy KJ, Foster NC, et al; T1D Exchange Intranasal Glucagon Investigators. Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes: a randomized crossover noninferiority study. Diabetes Care. 2016;39(2):264-270. https://doi.org/10.2337/dc15-1498

Glossary

BG = blood glucose

IM = intramuscular

NG = nasal glucagon (glucagon nasal powder)

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M07 24

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