Baqsimi ® (glukagon näspulver)

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Vilka effekts- och säkerhetsdata finns för Baqsimi® (glukagon näspulver) för patienter med typ 2 -diabetes?

Alla deltagare med typ 2 -diabetes mellitus, inkluderade i den primära analysen, uppnådde framgång med behandlingen med glukagon nasalt pulver och ingen av dem rapporterade en allvarlig biverkning.

SE_cFAQ_NG021_USE_IN_T2DM
SE_cFAQ_NG021_USE_IN_T2DM
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Adult Pivotal Study

Outcomes in the Efficacy Cohort

One participant in the type 2 diabetes mellitus (T2DM) group was excluded due to high blood glucose (BG) nadir, ≥3.9 mmol/L (≥70 mg/dL)

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

All the other 5 participants with T2DM included in the analysis achieved treatment success within 30 minutes after receiving study glucagon (Treatment Outcome and Blood Glucose Parameters in Participants With T2DM Included in the Efficacy Cohort).1

Treatment Outcome and Blood Glucose Parameters in Participants With T2DM Included in the Efficacy Cohort1

T2DM Participants

Success, Yes/No

Glucose at t=0a,  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

1

yes

3.1 (56)

2.8 (51)

10

10

2

yes

3.0 (54)

3.0 (54)

10

15

3

yes

3.3 (59)

3.3 (59)

10

15

4

yes

3.7 (67)

3.3 (60)

10

15

5

yes

2.6 (46)

2.4 (44)

20

15

Abbreviations: BG = blood glucose; T2DM = type 2 diabetes mellitus.

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

Outcomes in the Safety Cohort

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

3 participants in the nasal glucagon (NG) treatment group reported 4 adverse reactions (Spontaneously Reported Adverse Reactions in the NG Treatment Arm in Participants With T2DM Included in the Safety Cohort).1

Spontaneously Reported Adverse Reactions in the NG Treatment Arm in Participants With T2DM Included in the Safety Cohorta1

Adverse Reaction, number of events

NG 3 mg
N=6

Nausea

1

Nasal congestion

1

Weakness/fatigue

1

Pruritus

1

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

aThe 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.1

Study Design

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

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

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, and
  • a mean DM duration of 18.8 years.1

Adult Study in the Japanese Population

Results of the Efficacy Analysis

36 of the 39 participants with T2DM were evaluable for the efficacy analysis

  • two patients did not complete the study, and
  • one patient was considered non-evaluable due to a Plasma Glucose (PG) nadir of 3.9 mmol/L (70 mg/dL) during treatment visit 1.3

The nadir was defined as the minimum PG value at or within 10 minutes after glucagon administration.3

All 36 achieved treatment success by 25 minutes post dose. The mean time to treatment success was 12.4 minutes.3

Results of the Safety Analysis

Safety analyses were conducted on all randomized patients receiving ≥1 dose of the study drug.3

The NG-related treatment-emergent adverse events (TEAE), not stratified by diabetes type, are shown in Summary of treatment-emergent adverse events in overall safety population.3

Summary of treatment-emergent adverse events in overall safety population3

 

Nasal glucagon 3 mg (N = 71)

 

Number of AEs  

Patients with AEs, n (%)  

Overall TEAEs

26

12 (16.9)

Rhinalgia

6

6 (8.5)

Nausea

4

4 (5.6)

Blood pressure increased

4

4 (5.6)

Vomiting

2

2 (2.8)

Ear pain

2

2 (2.8)

Headache

1

1 (1.4)  

Eye pain

1

1 (1.4)  

Eye pruritus

1

1 (1.4)  

Lacrimation increased

1

1 (1.4)  

Nasal congestion

1

1 (1.4)  

Nasal pruritus

1

1 (1.4)  

Oropharyngeal pain

1

1 (1.4)  

Toothache

1

1 (1.4)  

Abbreviations: AEs = adverse events; n = number of patients in group; N = number of patients in population; TEAEs = treatment emergent adverse events.

No death or discontinuation related to adverse event were reported.3

Study Design

This was a phase 3, multicentre, randomized, open-label, active-comparator, single-dose, two-period, two-treatment (NG and IM) crossover study in Japanese patients with T1DM or T2DM.3

The primary objective was to demonstrate NG 3 mg was non-inferior to IM 1 mg for the percentage of patients achieving success of treatment for insulin-induced hypoglycaemia.3

Treatment success was defined as an

  • increase in PG to ≥3.9 mmol/L (≥70 mg/dL), or
  • increase of ≥1.1 mmol/L (≥20 mg/dL) from nadir within 30 minutes after glucagon administration, without additional measures to increase PG.3

39 adults with T2DM received ≥1 dose of study drug, and had

  • a mean age of 57.5 ± 9.2 years
  • a diabetes duration of 15.7 ± 9.4 years, and
  • a body mass index of 25.5 ± 3.1 kg/m2.3

References

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

2Rickels 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

3Matsuhisa M., Takita Y., Nasu R., et al. Nasal glucagon as a viable alternative for treating insulin-induced hypoglycaemia in Japanese patients with type 1 or type 2 diabetes: A phase 3 randomized crossover study. Diabetes Obes. Metab. 2020;22(7):1167-1175. http://dx.doi.org/10.1111/dom.14019

Datum fӧr senaste ӧversyn 2019 M07 24


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