American Diabetes Association

Table 3—

Screening levels and changes from screening in NSC scores, NIS, and NIS_[LL] after 5 weeks of treatment (last value carried forward)

	Placebo	ALA600	ALA1200	ALA1800
NSC number
Screening	6.8 ± 1.7	7.0 ± 1.6	7.1 ± 1.5	6.6 ± 1.5
Change	−1.7 ± 2.1	−2.8 ± 2.1^*	−2.8 ± 2.2^*	−2.7 ± 2.5^†
NSC severity
Screening	14.1 ± 4.3	14.4 ± 4.4	14.7 ± 4.5	13.5 ± 3.5
Change	−4.9 ± 4.3	−7.4 ± 4.6^*	−7.2 ± 5.0^*	−7.6 ± 4.2^*
NSC change
Screening	−0.1 ± 0.7	0.0 ± 0.3	−0.2 ± 0.6	0.0 ± 0.3
Change	+5.4 ± 4.6	+8.6 ± 5.6^*	+8.5 ± 5.3^*	+9.5 ± 5.1^*
NIS
Screening	19.2 ± 17.1	19.4 ± 17.6	18.7 ± 14.1	17.6 ± 15.8
Change	−2.38 ± 6.06	−3.80 ± 4.61	−3.85 ± 4.57^*	−3.85 ± 6.49^‡
NIS_[LL]
Screening	14.5 ± 14.6	15.4 ± 14.4	15.0 ± 11.1	13.0 ± 11.6
Change	−2.08 ± 5.57	−3.75 ± 4.41^§	−2.63 ± 3.28	−2.70 ± 5.33
NIS_[LL] sensory function
Screening	7.05 ± 3.21	6.80 ± 3.76	7.21 ± 2.82	6.53 ± 2.79
Change	−1.05 ± 1.99	−2.25 ± 2.27^*	−1.73 ± 1.72^‖	−1.55 ± 1.81

	Placebo	ALA600	ALA1200	ALA1800
NSC number
Screening	6.8 ± 1.7	7.0 ± 1.6	7.1 ± 1.5	6.6 ± 1.5
Change	−1.7 ± 2.1	−2.8 ± 2.1^*	−2.8 ± 2.2^*	−2.7 ± 2.5^†
NSC severity
Screening	14.1 ± 4.3	14.4 ± 4.4	14.7 ± 4.5	13.5 ± 3.5
Change	−4.9 ± 4.3	−7.4 ± 4.6^*	−7.2 ± 5.0^*	−7.6 ± 4.2^*
NSC change
Screening	−0.1 ± 0.7	0.0 ± 0.3	−0.2 ± 0.6	0.0 ± 0.3
Change	+5.4 ± 4.6	+8.6 ± 5.6^*	+8.5 ± 5.3^*	+9.5 ± 5.1^*
NIS
Screening	19.2 ± 17.1	19.4 ± 17.6	18.7 ± 14.1	17.6 ± 15.8
Change	−2.38 ± 6.06	−3.80 ± 4.61	−3.85 ± 4.57^*	−3.85 ± 6.49^‡
NIS_[LL]
Screening	14.5 ± 14.6	15.4 ± 14.4	15.0 ± 11.1	13.0 ± 11.6
Change	−2.08 ± 5.57	−3.75 ± 4.41^§	−2.63 ± 3.28	−2.70 ± 5.33
NIS_[LL] sensory function
Screening	7.05 ± 3.21	6.80 ± 3.76	7.21 ± 2.82	6.53 ± 2.79
Change	−1.05 ± 1.99	−2.25 ± 2.27^*	−1.73 ± 1.72^‖	−1.55 ± 1.81

Data are means ± SD. Negative values correspond to improvement.

P < 0.05,

†

P = 0.08,

‡

P = 0.055,

P = 0.07, and

‖

P = 0.09 (each vs. placebo).