Outcome measures (pairwise comparisons) using insulin detemir or NPH insulin as basal insulin therapy in type 1 diabetes
Measure | Group 1 | Group 2 | Mean difference (95% CI) | P |
---|---|---|---|---|
HbA1c (%) | IDetcombined | NPH | −0.2 (−0.34 to −0.02) | 0.027 |
Clinic FPG (mmol/l) | IDet12h | NPH | −1.5 (−2.51 to −0.48) | 0.004 |
IDetmorn+bed | NPH | −2.3 (−3.32 to −1.29) | <0.001 | |
IDet12h | IDetmorn+bed | 0.8 (−0.18 to 1.80) | NS | |
Self-monitored fasting blood glucose | ||||
Mean | IDet12h | NPH | −0.8 (−1.32 to −0.22) | 0.006 |
IDetmorn+bed | NPH | −0.8 (−1.34 to −0.25) | 0.004 | |
IDet12h | IDetmorn+bed | 0.0 (−0.51 to 0.56) | NS | |
Within-patient SD* | IDet12h | NPH | <0.001 | |
IDetmorn+bed | NPH | <0.001 | ||
IDet12h | IDetmorn+bed | NS | ||
Body weight change (kg) | IDet12h | NPH | −0.8 (−1.44 to −0.24) | 0.006 |
IDetmorn+bed | NPH | −0.6 (−1.23 to −0.03) | 0.040 | |
IDet12h | IDetmorn+bed | −0.2 (−0.80 to 0.37) | NS | |
CGMS glucose profiles deviation from average (mmol/l · h) | ||||
>24 h | IDetcombined | NPH | −6.45 (−13.3 to 0.40) | 0.065 |
Overnight | IDetcombined | NPH | −1.72 (−4.05 to −0.62) | NS |
Hypoglycemia in final 12 weeks [RR (95% CI)]† | ||||
Minor-any time | IDet12h | NPH | 0.75 (0.56–1.00) | 0.046 |
IDetmorn+bed | NPH | 0.68 (0.56–0.84) | 0.002 | |
Minor-nocturnal | IDet12h | NPH | 0.74 (0.50–1.08) | NS |
IDetmorn+bed | NPH | 0.47 (0.36–0.62) | <0.001 |
Pairwise testing was only performed where allowed by the protocol (see research design and methods); accordingly only limited comparisons are given.
↵* Data distribution did not allow calculation of mean difference and CIs for within-patient variability;
↵† estimates of the relative risk of hypoglycemic episodes during the maintenance period calculated using a recurrent event γ-frailty model. IDetcombined, insulin detemir groups combined.