Table 3.

Hypoglycemia adjusted for HbA_1c at endpoint.

n (%)	Glargine (n = 498)	NPH (n = 486)	Unadjusted odds ratio (95% CI)	p valuea	Odds ratio (95% CI) adjusted for HbA1c at endpoint	p valuea
Incidence of people experiencing at least one hypoglycemia event and odds ratios
Total (all symptomatic)	389 (78.1%)	405 (83.3%)	0.71 (0.52, 0.98)	0.039	0.74 (0.54, 1.02)	0.070
Symptomatic <2.0 mmol/L (<36 mg/dL)	153 (30.7%)	183 (37.7%)	0.73 (0.56, 0.96)	0.022	0.76 (0.58, 0.99)	0.038
Symptomatic <3.9 mmol/L (<70 mg/dL)	358 (71.9%)	380 (78.2%)	0.71 (0.53, 0.95)	0.023	0.74 (0.55, 1.00)	0.048
Severe	40 (8.0%)	60 (12.3%)	0.62 (0.41, 0.95)	0.026	0.64 (0.42, 0.97)	0.035
All daytime	326 (65.5%)	354 (72.8%)	0.71 (0.54, 0.93)	0.012	0.74 (0.56, 0.97)	0.030
All nocturnal	269 (54.0%)	282 (58.0%)	0.85 (0.66, 1.09)	0.206	0.86 (0.67, 1.11)	0.259
Rates of hypoglycemia per patient-yearb
			Unadjusted rate ratio (95% CI)	p valuea	Rate ratio (95% CI) adjusted for HbA1c at endpoint	p valuea
Total (all symptomatic)c	5.346 (0.389)	7.449 (0.547)	0.71 (0.58, 0.87)	<0.001	0.72 (0.59, 0.88)	0.001
Symptomatic <2.0 mmol/L (<36 mg/dL)	0.312 (0.039)	0.793 (0.095)	0.40 (0.29, 0.56)	<0.001	0.39 (0.28, 0.55)	<0.001
Symptomatic <3.9 mmol/L (<70 mg/dL)	4.845 (0.384)	6.785 (0.543)	0.70 (0.56, 0.87)	0.002	0.71 (0.57, 0.89)	0.003
Severec	0.041 (0.008)	0.065 (0.012)	0.63 (0.38, 1.07)	0.087	0.63 (0.37, 1.07)	0.085
All daytimec	3.843 (0.290)	5.426 (0.413)	0.69 (0.56, 0.86)	<0.001	0.71 (0.57, 0.88)	0.001
All nocturnalc	1.514 (0.141)	2.017 (0.189)	0.75 (0.58, 0.97)	0.028	0.75 (0.58, 0.97)	0.030

Intention-to-treat population. HbA_1c = glycosylated hemoglobin; NPH = neutral protamine Hagedorn; CI = confidence interval.

^aTwo-sided p value for the null hypothesis: odds ratio = 1 or rate ratio = 1, respectively.

^bHypoglycemia rates per patient-year from negative binomial regression.

^cStandard error shown in parentheses.