Selected efficacy and safety data after 6 months of treatment with insulin detemir or NPH insulin
| . | Insulin detemir . | NPH insulin . | Difference (detemir-NPH) . | Relative risk (detemir/NPH) . | P . |
|---|---|---|---|---|---|
| Glycemic control | |||||
| HbA1c (%)* (n = 280 and 139) | 7.60 ± 0.09 | 7.64 ± 0.10 | −0.04 (−0.218 to 0.128) | 0.61 | |
| FPG (mmol/l)* (all patients; n = 274 and 138) | 9.19 ± 0.44 | 9.94 ± 0.52 | −0.76 (−1.65 to 0.14) | 0.09 | |
| Daily insulin dose [nmol (U/IU)]† | |||||
| Basal | 710 (59.2 U) | 190 (31.7 IU) | |||
| Bolus | 184 (30.7 U) | 156 (26.0 U) | |||
| Variability (fasting SMBG) | |||||
| Mean fasting SMBG (mmol/l) (n = 271 and 137) | 8.80 | 9.23 | |||
| Within-subject variation (SD) (n = 271 and 137) | 3.37 | 3.78 | <0.001 | ||
| Body weight | |||||
| Final weight (kg)‡ (n = 282 and 138) | 70.9 ± 0.28 | 71.8 ± 0.33 | −0.98 | 0.001 | |
| Hypoglycemia (episodes over the last 5 months; proportion of patients with ≥1 episode) | |||||
| All events | 7,522; 271; 5.18§ | 4,820; 138; 6.70 | 0.78 (0.62 to 0.97) | 0.029 | |
| Major | 56; 24; 0.04 | 41; 21; 0.06 | 0.65 (0.28 to 1.50) | 0.312 | |
| Minor | 3,184; 259; 2.19 | 2,180; 129; 3.03 | 0.72 (0.56 to 0.93) | 0.011 | |
| Symptoms only | 4,271; 236; 2.94 | 2,595; 121; 3.61 | 0.83 (0.62 to 1.11) | 0.213 | |
| Nocturnal (any) | 923; 198; 0.64 | 689; 110; 0.96 | 0.66 (0.50 to 0.87) | <0.005 |
| . | Insulin detemir . | NPH insulin . | Difference (detemir-NPH) . | Relative risk (detemir/NPH) . | P . |
|---|---|---|---|---|---|
| Glycemic control | |||||
| HbA1c (%)* (n = 280 and 139) | 7.60 ± 0.09 | 7.64 ± 0.10 | −0.04 (−0.218 to 0.128) | 0.61 | |
| FPG (mmol/l)* (all patients; n = 274 and 138) | 9.19 ± 0.44 | 9.94 ± 0.52 | −0.76 (−1.65 to 0.14) | 0.09 | |
| Daily insulin dose [nmol (U/IU)]† | |||||
| Basal | 710 (59.2 U) | 190 (31.7 IU) | |||
| Bolus | 184 (30.7 U) | 156 (26.0 U) | |||
| Variability (fasting SMBG) | |||||
| Mean fasting SMBG (mmol/l) (n = 271 and 137) | 8.80 | 9.23 | |||
| Within-subject variation (SD) (n = 271 and 137) | 3.37 | 3.78 | <0.001 | ||
| Body weight | |||||
| Final weight (kg)‡ (n = 282 and 138) | 70.9 ± 0.28 | 71.8 ± 0.33 | −0.98 | 0.001 | |
| Hypoglycemia (episodes over the last 5 months; proportion of patients with ≥1 episode) | |||||
| All events | 7,522; 271; 5.18§ | 4,820; 138; 6.70 | 0.78 (0.62 to 0.97) | 0.029 | |
| Major | 56; 24; 0.04 | 41; 21; 0.06 | 0.65 (0.28 to 1.50) | 0.312 | |
| Minor | 3,184; 259; 2.19 | 2,180; 129; 3.03 | 0.72 (0.56 to 0.93) | 0.011 | |
| Symptoms only | 4,271; 236; 2.94 | 2,595; 121; 3.61 | 0.83 (0.62 to 1.11) | 0.213 | |
| Nocturnal (any) | 923; 198; 0.64 | 689; 110; 0.96 | 0.66 (0.50 to 0.87) | <0.005 |
Data are means ± SE except where indicated. 95% CIs are shown for the difference between groups.
Estimated means with correction for baseline values.
Insulin detemir: 1 unit (U) = 12 nmol, NPH insulin: 1 unit (IU) = 6 nmol, IAsp: 1 unit (U) = 6 nmol.
The analysis is based on an ANOVA model with treatment as fixed effect and weight at baseline as covariate. Only those patients who provided information for the analysis of weight are included in the table.
Data are number of episodes; number of patients with at least one hypoglycemic episode; events per subject month.