Table 1.

Studies conducted in patients with type 1 diabetes

Study (reference)	Comparator	Additional glucose-lowering treatment	Trial duration (weeks)	Participants (n, ITT)	Baseline HbA1c (%)	Endpoint HbA1c (%)	Mean weight change (kg)	Hypoglycemia (relative risk for detemir)		Mean endpoint SMFPG (mmol/L)	Within-patient SD in FPG (mmol/L)
					Comparator	Comparator	Comparator	24 hours	Nocturnal	Comparator	Comparator
a Home et al48	NPH	Insulin aspart	16	137/139	8.55/8.74	7.75/7.78	+0.02/+0.24	0.75*/0.68**	0.74/0.47***	8.28/8.26	2.95/2.91
				132	8.52	7.94	+0.86*			9.05**	3.49***
Russell-Jones et al52	NPH	Regular human insulin	26	491	8.35	8.30	−0.23	0.94	0.74**	7.56	2.82
				256	8.35	8.41	+0.31*			8.47***	3.60***
a Pieber et al50	NPH	Insulin aspart	16	139/132	8.01/8.13	7.67/7.65	−0.6/+0.1	Not reported	Not reported	8.20/8.00	2.49/2.61
				129	8.08	7.73	+0.7*,***			8.31	3.09***
Kølendorf et al49 (crossover)	NPH	Insulin aspart	2 × 16	130	7.90	7.60	N/A	0.82**	0.50***	7.63	2.69
					7.90	7.60	N/A			8.66***	3.23***
b Robertson et al56	NPH	Insulin aspart	26	232	8.80	8.0	N/A	0.89	0.74*	8.40	3.3
				115	8.70	7.90				9.60*	4.3***
Bartley et al54	NPH	Insulin aspart	104	331	8.3	7.36	+1.7	0.74	0.54***	8.35c	2.18
				166	8.4	7.58*	+2.7			9.43*,c	2.52***
Heller et al59	Insulin glargine	Insulin aspart	58	299	8.1	7.57	+0.36	0.94	1.12	8.58	2.55
				144	8.1	7.56	+0.42			8.81	2.39

^aNotes: Data for detemir in Home et al⁴⁸ are given as 12-hourly/morning + bedtime injection regimens. Data for detemir in Pieber et al⁵⁰ are given as morning + dinner time/morning + bedtime injection regimens;

^bstudy included children and/or adolescents.

^cClinical (laboratory) measured FPG.

^*P < 0.05;

^**P < 0.01;

^***P < 0.001.

Abbreviations: FPG, fasting plasma glucose; NPH, neutral protamine Hagedorn insulin; HbA_1c, glycosylated hemoglobin; ITT, intent to treat; SMFPG, self-measured fasting plasma glucose; SD, standard deviation.