Table 4.

Effects of GH treatment on safety parameters in GHD children in the phase III study ‘safety set’ (SS). All values are mean ± s.d., and the data is derived from the ‘safety set’.

	Baseline		Week 13		Week 25
Parameter	PEG-rhGH (n = 228)	Daily rhGH (n = 115)	PEG-rhGH (n = 228)	Daily rhGH (n = 115)	PEG-rhGH (n = 228)	Daily rhGH (n = 115)
Insulin (U/L)	3.54 ± 2.96	4.44 ± 3.65*	5.99 ± 8.08	7.29 ± 8.21	6.46 ± 7.70	8.63 ± 10.21
Fasting blood glucose (mmol/L)	4.53 ± 0.60	4.64 ± 0.61	4.91 ± 0.69	4.96 ± 0.74	4.97 ± 0.66	5.03 ± 0.68
2-h postprandial blood glucose (mmol/L)	5.88 ± 1.36	5.87 ± 1.07	6.26 ± 0.96	6.10 ± 0.90	6.07 ± 1.00	6.03 ± 0.86
HbAlc (%)	5.38 ± 0.57	5.33 ± 0.60	5.46 ± 0.61	5.47 ± 0.74	5.46 ± 0.43	5.50 ± 0.44
HOMA-IR	0.11 ± 0.09	0.13 ± 0.11*	0.19 ± 0.23	0.23 ± 0.26	0.21 ± 0.24	0.28 ± 0.31*
Total cholesterol (mmol/L)	4.41 ± 0.96	4.47 ± 1.01	4.10 ± 0.95	4.07 ± 0.70	4.25 ± 0.97	4.23 ± 0.80
Triglycerides (mmol/L)	1.02 ± 0.76	0.92 ± 0.56	1.18 ± 0.71	1.09 ± 0.56	1.03 ± 0.74	1.03 ± 0.84

Differences between the two groups were compared using t-test.

^*P < 0.05.

HbAlc, glycated hemoglobin; HOMA-IR, homeostasis model assessment of insulin resistance.