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BAQSIMI(glucagon)nasal powder(七)
acy outcome measure was the proportion of patients achieving treatment success, which wasdefined as either an increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within30 minutes after receiving study glucagon, without receiving additional actions to increase the blood glucose level.
Glucose nadir was defined as the minimum glucose measurement at the time of, or within 10 minutes, followingglucagon administration.
The mean nadir blood glucose was 54.5 mg/dL for BAQSIMI and 55.8 mg/dL for IMG. BAQSIMI demonstratednon-inferiority to IMG in reversing insulin-induced hypoglycemia with 100% of BAQSIMI-treated patients and 100%of IMG-treated patients achieving treatment success. The mean time to treatment success was 11.6 and 9.9
minutes in the BAQSIMI and IMG 1 mg treatment groups, respectively.
Table 5: Adult Patients with Type 1 Diabetes Meeting Treatment Success and Other Glucose Criteria in Study 1
Type 1 Diabetes
(N=66)
a
BAQSIMI
3 mg
IMG
1 mg
Treatment Success – n (%) 66 (100%) 66 (100%)
Treatment Difference (2-sided 95% confidence limit)b, c 0% (-2.9%, 2.9%)
Glucose criterion met – n (%)
(i) ≥70 mg/dL
(ii) Increase by ≥20 mg/dL from nadir
Both (i) and (ii)
66 (100%)
66 (100%)
66 (100%)
66 (100%)
66 (100%)
66 (100%)
a
The Efficacy Analysis Population consisted of all patients who received both doses of the Study Drug with eva luableprimary outcome.
b Difference calculated as (percentage with success in BAQSIMI) – (percentage with success in IMG).
c
2-sided 95% confidence interval (CI) of paired differences using a Wald-Min correction; non-inferiority margin = -10%.
Study 2 (NCT01994746) was a randomized, multicenter, open-label, 2-period, crossover study in adult patientswith type 1 diabetes or type 2 diabetes. The efficacy of a single 3 mg dose of BAQSIMI was compared to a 1 mgdose of intra-muscular glucagon (IMG). Insulin was used to reduce blood glucose levels to the hypoglycemic range
with a target blood glucose nadir of <50 mg/dL.
Study 2 enrolled 83 patients 18 to <65 years of age. The mean age of patients with type 1 diabetes (N=77) was32.9 years and a mean diabetes duration of 18.1 years, and 45 (58%) patients were female. The mean age ofpatients with type 2 diabetes (N=6) was 47.8 years, with a mean diabetes duration of 18.8 years, and 4 (67%)patients were female.
The mean nadir blood glucose was 44.2 mg/dL for BAQSIMI and 47.2 mg/dL for IMG. BAQSIMI demonstratednon-inferiority to IMG in reversing insulin-induced hypoglycemia with 98.8% of BAQSIMI-treated patients and100% of IMG-treated patients achieving treatment success within 30 minutes.
The mean time to treatment success was 15.9 and 12.1 minutes in the BAQSIMI and IMG 1 mg treatment groups,respectively.
10
Table 6: Adult Patients with Type 1 and Type2 Diabetes Meeting Treatment Success and Other Glucose Criteria
in Study 2
Type 1 and Type 2 Diabetes (N=80)a
BAQSIMI
3 mg
IMG
1 mg
Treatment Success – n (%) 79 (98.8%) 80 (100%)
Treatment Difference (2-sided 95% confidence limit) b,c
-1.3% (-4.6%, 2.2%)
Glucose criterion met – n (%)
d
(i) ≥70 mg/dL 77 (96%) 79 (99%)
(ii) Increase by ≥20 mg/dL from nadir 79 (99%) 80 (100%)
Both (i) and (ii) 77 (96%) 79 (99%)
a
The Efficacy Analysis Population consisted of all patients who received both doses of the Study Drug with eva luableprimary |
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