Table 2.

Mean change in HbA1C (%) from baseline to week 6 and week 12 (PP population)

	Mean change in HbA1c (%) (mean ± SD)
	PMR group (N = 71)	SOC group (N = 71)
Baseline	8.05 ± 0.82	7.88 ± 0.85
Visit 2 (week 6)	7.78 ± 0.76	7.77 ± 0.97
Mean difference p value	− 0.26 ± 0.48 (0.001)	− 0.10 ± 0.67 (0.215)
p value	0.106*
Visit 3 (week 12)	7.42 ± 0.68	7.72 ± 1.15
Mean difference p value	− 0.62 ± 0.65 (0.001)	− 0.16 ± 0.98 (0.173)
p value	0.001**

All values are presented as mean ± SD. p value: calculated using Student’s t test. *p values for within group comparison; **p value for between group comparison

HbA1c glycated hemoglobin, PMR partial meal replacement, PP per-protocol, SD standard deviation, SOC standard of care

The PP population consisted of all enrolled patients who had completed the study as per the protocol without major protocol deviation

The bold values indicate statistical significance