Table 3.

Non-parametric summary statistics and subgroup analysis for change in AUC of C-peptide from baseline to year 1

	14-day full-dose group (n=207)	14-day low-dose group (n=102)	6-day full-dose group (n=106)	Placebo group (n=98)	p value
Region
USA	−0·10 (n=63; −0·30 to 0·16)	−0·17 (n=32; −0·29 to 0·02)	−0·18 (n=30; −0·43 to 0·11)	−0·27 (n=30; −0·50 to −0·14)	0·015
India	−0·00 (n=55; −0·15 to 0·24)	−0·09 (n=27; −0·35 to 0·00)	−0·06 (n=27; −0·15 to 0·42)	−0·04 (n=27; −0·13 to 0·31)	0·824
Europe and Israel	−0·11 (n=70; −0·25 to 0·03)	−0·15 (n=37; −0·39 to 0·01)	−0·05 (n=36; −0·26 to 0·16)	−0·14 (n=34; −0·27 to 0·01)	0·422
Canada and Mexico	0·01 (n=13; −0·02 to 0·21)	−0·02 (n=4; −0·31 to 0·36)	−0·09 (n=9; −0·38 to 0·04)	0·03 (n=5; −0·19 to 0·23)	0·657
Age-group (years)
8–11	0·02 (n=31; −0·25 to 0·20)	−0·17 (n=15; −0·34 to 0·01)	−0·22 (n=14; −0·38 to −0·03)	−0·30 (n=14; −0·45 to 0·09)	0·047
12–17	−0·09 (n=78; −0·27 to 0·03)	−0·22 (n=40; −0·39 to −0·02)	−0·014 (n=42; −0·40 to 0·04)	−0·20 (n=38; −0·29 to −0·02)	0·114
18–35	−0·06 (n=92; −0·22 to 0·13)	−0·05 (n=45; −0·26 to 0·09)	−0·00 (n=46; −0·12 to 0·30)	−0·07 (n=44; −0·27 to 0·10)	0·959
Time from diagnosis to randomisation (weeks)
≤6	0·02 (n=41; −0·13 to 0·39)	−0·04 (n=20; −0·27 to 0·11)	0·17 (n=14; −0·11 to 0·30)	−0·15 (n=16; −0·38 to 0·09)	0·020
>6	−0·09 (n=160; −0·27 to 0·06)	−0·17 (n=80; −0·37 to 0·01)	−0·10 (n=88; −0·35 to 0·05)	−0·14 (n=80; −0·28 to 0·02)	0·332

Data are median (n; IQR) and are in units of nmol/L per min. Missing values were imputed with last observation carried forward. 14 patients (six in the 14-day full-dose group, two in the 14-day low-dose group, four in the 6-day full-dose group, and two in the placebo group) were not included in the last-observation-carried-forward analyses because no C-peptide data were obtained. AUC=area under the curve.

^*14-day full-dose group versus placebo group; Wilcoxon rank-sum test.