Table 5

Variable	Model	Period	Rate/30 Days (Mean ± SE)		Relative Rate (LM versus BBT)
Variable	Model	Period	BBT³	LM⁴	Mean ± SE	95% CI	p-value
Nocturnal Hypoglycemic events	PWNB	0-12 Week	0.42 ± 0.07	0.35 ± 0.04	1.19 ± 0.25	(0.78,1.80)	0.41
		12-24 Week	0.68 ± 0.08	0.51 ± 0.06	1.32 ± 0.22	(0.94,1.84)	0.10
		0-24 Week¹	0.53 ± 0.07	0.43 ± 0.05	1.25 ± 0.21	(0.90,1.74)	0.18
		0-24 Week²	0.55 ± 0.07	0.43 ± 0.05	1.27 ± 0.21	(0.92,1.74)	0.15
	NB	0-12 Week	0.42 ± 0.07	0.35 ± 0.04	1.19 ± 0.25	(0.78,1.80)	0.42
		12-24 Week	0.66 ± 0.08	0.52 ± 0.06	1.27 ± 0.22	(0.90,1.78)	0.17
		0-24 Week	0.54 ± 0.07	0.43 ± 0.05	1.24 ± 0.20	(0.90, 1.72)	0.19
Total Hypoglycemic events	PWNB	0-12 Week	3.47 ± 0.29	4.09 ± 0.33	0.85 ± 0.10	(0.68,1.07)	0.16
		12-24 Week	5.24 ± 0.41	5.05 ± 0.37	1.04 ± 0.11	(0.84,1.28)	0.73
		0-24 Week¹	4.26 ± 0.30	4.54 ± 0.31	0.94 ± 0.09	(0.77,1.14)	0.52
		0-24 Week²	4.35 ± 0.31	4.57 ± 0.31	0.95 ± 0.09	(0.79,1.16)	0.63
	NB	0-12 Week	3.48 ± 0.29	4.07 ± 0.33	0.85 ± 0.10	(0.68,1.07)	0.18
		12-24 Week	5.23 ± 0.41	5.19 ± 0.38	1.01 ± 0.11	(0.82,1.24)	0.95
		0-24 Week	4.33 ± 0.31	4.60 ± 0.32	0.94 ± 0.09	(0.77, 1.14)	0.53

¹The rate and relative rate were estimated using the methods for ζ₁ and ζ₂ in Section 2.2.1
²The rate and relative rate were estimated using the methods for ζ₃ as described in Section 2.2.1
³ N=171 and 163 for 0-12 week and 12-24 week, respectively;
⁴N=173 and 158 for 0-12 week and 12-24 week, respectively;
Abbreviation: BBT=basal bolus therapy (glargine at bedtime plus mealtime insulin lispro); LM=lispro mix 50/50 (50% insulin lispro protamine suspension and 50% lispro); LS Mean=Least square mean; SE=Standard error; NB = Negative binomial; PWNB = Piecewise negative binomial

Table 5: The estimated relative rate, SE for each group, and the relative rate, 95% CI and p-value for comparison of LM versus BBT for nocturnal and total hypoglycemic events.