Table 1.

Within-subject Variability of Pharmacokinetic and Pharmacodynamic Summary Measures After Repeated sc Injection of 0.1 IU/kg Body Weight of a Novel Rapid-acting Insulin in Comparison to Regular Human Insulin in 14 patients with Type 1 Diabetes.

Pharmacokinetic parameters	Unit	Differences between insulin formulations			Average of within-subject standard deviation (SD)			Difference (95% Confidence Interval)
		p-value	Means		p-value	RHI SD	UFI SD
			RHI	UFI
Cmax	(mU/liter)	0.0086	23.7	32.7	0.6240	10.0	7.6	2.4 (−7.9 to 12.7)
tCmax	(min)	<0.0001	97	33	0.0270	39	16	24 (3 to 45)
tCmax+50%	(min)	<0.0001	32	8	0.0229	20	6	14 (2 to 25)
tCmax−50%	(min)	<0.0001	215	131	0.0845	65	35	30 (−5 to 65)
AUCINS 0-180	(mU/liter*min)	<0.0001	2552	3442	0.7647	665	626	38 (−232 to 309)
AUCINS 0–480	(mU/liter*min)	0.9612	4410	4395	0.5308	916	823	94 (−220 to 407)
Pharmacodynamic parameters
GIRmax	(mg/kg/min)	<0.0001	4.1	5.6	0.4745	1.3	1.5	−0.2 (−0.9 to 0.4)
tGIRmax	(min)	0.0015	154	99	0.0221	74	36	38 (6 to 69)
tGIRmax+50%	(min)	0.1317	51	38	0.0601	32	17	15 (−1 to 31)
tGIRmax−50%	(min)	0.0062	165	119	0.0759	72	39	33 (−4 to 70)
AUCGIR 0-180	(mg/kg)	<0.0001	276	458	0.3804	89	112	−23 (−79 to 32)
AUCGIR 0-480	(mg/kg)	0.2197	592	647	0.2889	199	151	47 (−45 to 140)
AUCGIR 180-480	(mg/kg)	0.0001	311	193	0.0182	135	67	68 (14 to 123)

^aValues in bold indicate significant changes in variability.