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Table 2—

Selected efficacy and safety data after 6 months of treatment with insulin detemir or NPH insulin

Insulin detemirNPH insulinDifference (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 detemirNPH insulinDifference (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.

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