Baqsimi ® (glukagon näspulver)

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Baqsimi® (glukagon näspulver): Upprepad dos

Högre glukagonkoncentration med upprepade doser av glukagon näspulver ledde inte till kliniskt betydelsefulla ökningar i glukosrespons jämfört med en enkeldos av glukagon näspulver.

Detailed Information

A 4-period, crossover study evaluated the PK, PD, and safety of a single dose or repeated dose NG 3 mg in 23 adult participants with T1DM and in 9 adult participants with T2DM.1,2 The mean age of the participants was 39 ± 12 years.2 The participants’ blood glucose concentrations at baseline ranged from 40 to 181 mg/dL.1,2

There have been no studies conducted with repeated doses of NG in pediatric or elderly participants.

The 4 treatments were administered at least 1 week apart and 4 hours after a low carbohydrate breakfast and consisted of NG as

  • a single 3-mg dose

  • two 3-mg doses 15 minutes apart in the same nostril

  • two 3-mg doses 15 minutes apart in opposite nostrils, and

  • two 3-mg doses concurrently in both nostrils.1,2

Blood glucagon concentrations were similar within 10 minutes after dosing in all NG treatment groups and continued to increase for 20 to 30 minutes in treatment groups with repeated NG dosing. The higher blood glucagon concentration with repeated NG dosing did not result in clinically meaningful increases in glucose response compared with single dosing of NG (Table 1).2

Table 1. Change From Baseline in PK Parameters of Glucagon and PD Parameters of Glucose After Repeat Dose of NG1,2

Parametera 

Treatment 1b
n=27

Treatment 2c
n=28

Treatment 3d
n=25

Treatment 4e
n=29

Change from baseline in PK parameters of glucagon

AUC0-1.5hr, hr.pg/mL

2359

3878f

4440f

3381f

AUC0-3 hr, hr.pg/mL

2471

4097f

4639f

3611f

Cmax,pg/mL

4958

7141

8083

6654

Tmax,hr, median

0.17

0.33

0.50

0.33

Change from baseline in PD parameters of glucose

AUEC0-1.5hr, mg/dL∙hr

93

97

111

106

AUEC0-3 hr, mg/dL∙hr

157

168

190

194

Cmax,mg/dL

90

98

108g

105

Tmax,hr, median

0.75

1.00

1.00

1.00

Abbreviations: AUC0-1.5 hr/0-3 hr = area under the curve from time zero to 1.5 or 3 hours; AUEC0-1.5 hr/0-3 hr = area under the effect curve from time zero to 1.5 or 3 hours; Cmax = maximum concentration; hr = hour; NG = nasal glucagon (glucagon nasal powder); PD = pharmacodynamics; PK = pharmacokinetics; Tmax = time to maximum concentration.

a Data presented as mean unless indicated otherwise.

b A single 3-mg dose.

c Two 3-mg doses 15 minutes apart in the same nostril.

d Two 3-mg doses 15 minutes apart in opposite nostrils.

e Two 3-mg doses concurrently in both nostrils.

f Significantly different from single dosing (Treatment 1), p≤.043.

g Significantly different from single dosing (Treatment 1), p=.049.

Single or repeated dosing of NG was well tolerated in the treatment groups. The most common adverse reactions were

  • lacrimation

  • headache, and

  • nasal discomfort.2

The adverse reactions were reported as mild (88.3%), moderate (11.3%), or severe (0.4%) with

  • 33% being resolved in less than 5 minutes

  • 43% being resolved within 15 minutes, and

  • 51% being resolved within 30 minutes after dosing.2

One serious adverse reaction of cellulitis was reported, but was deemed not related to NG treatment by the investigators.2

References

1. Dulude H, Sicard É, Rufiange M, et al. Pharmacokinetics (PK), pharmacodynamics (PD), and safety following single or repeated 3 mg doses of nasal glucagon (NG) in adults with type 1 or type 2 diabetes (T1D or T2D) [abstract]. Pediatr Diabetes. 2016;17(suppl 24):85. http://dx.doi.org/10.1111/pedi.12451

2. Dulude H, Sicard É, Rufiange M, et al. Pharmacokinetics, pharmacodynamics, and safety following single or repeated 3-mg doses of nasal glucagon in adults with type 1 or type 2 diabetes. Oral presentation at: 42nd Annual Meeting of the International Society for Pediatric and Adolescent Diabetes; October 26-29, 2016; Valencia, Spain.

Glossary

NG = nasal glucagon

PD = pharmacodynamic

PK = pharmacokinetic

T1DM = type 1 diabetes mellitus

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M09 05


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