Table 4.

Hypoglycemic events

	Hypoglycemic events and rates preindex and postindex by treatment group*†
Treatment	Preindex rate‡ n (mean±SD)	0–6 month postindex rate‡ n (mean±SD)	0–6 month postindex versus preindex	7–12 month postindex rate‡ n (mean±SD)	7–12 month postindex versus preindex	0–12 month postindex rate‡ n (mean±SD)	Change in annual rate (mean±SD)	0–12 month postindex versus preindex
U-500R only (group A)	16 (0.15±0.77)	34 (0.33±1.23)	p=0.026	30 (0.29±1.00)	p=0.071	64 (0.31±0.99)	0.15±0.95	p=0.021
U-500R with overlapping U-100 (group B)	36 (0.31±1.23)	57 (0.48±2.23)	p=0.062	54 (0.46±2.28)	p=0.199	111 (0.47±2.0)	0.17±1.29	p=0.051
Total	52 (0.23±1.04)	91 (0.41±1.83)	p=0.005	84 (0.38±1.80)	p=0.045	175 (0.39±1.61)	0.16±1.14	p=0.003
Group A versus group B	p=0.124	p=0.364	NA	p=0.318	NA	p=0.284	p=0.911	NA

	Patients with at least 1 hypoglycemic event in preindex or postindex
Treatment	preindex n (%)	0–6 month  postindex n (%)	0–6 month postindex versus preindex	7–12 month postindex n (%)	7–12 month postindex versus preindex	0–12 month postindex n (%)	0–12 month postindex versus preindex
U-500R only (group A)	10 (4.8)	19 (9.1)	p=0.0005	19 (9.1)	p=0.0005	26 (12.4)	p=0.007
U-500R with overlapping U-100 (group B)	20 (8.5)	23 (9.8)	p<0.0001	17 (7.2)	p<0.0001	27 (11.4)	p<0.0001
Total	30 (6.7)	42 (9.4)	p<0.0001	36 (8.1)	p<0.0001	53 (11.9)	p<0.0001
Group A versus group B	p=0.121	p=0.814	NA	p=0.466	NA	p=0.745	NA

	Hypoglycemic events in preindex or postindex by visit type/setting
Visit type	Preindex n (%)	0–6 month postindex n (%)	7–12 month postindex n (%)	0–12 month postindex n (%)
Office or clinic	40 (76.9)	80 (87.9)	72 (85.7)	152 (86.9)
Emergency	3 (5.8)	1 (1.1)	2 (2.4)	3 (1.7)
Inpatient	5 (9.6)	7 (7.7)	7 (8.3)	14 (8.0)
Other	1 (1.9)	1 (1.1)	2 (2.4)	3 (1.7)
Not recorded/missing	3 (5.8)	2 (2.2)	1 (1.2)	3 (1.7)

*Total: N=445; group A: n=209; group B: n=236.

†No hypoglycemic coma events were captured.

‡Annualized rate=hypoglycemic events per patient per year.

NA, not applicable; N/n, number of patients.