Table 3—

Outcome measures (pairwise comparisons) using insulin detemir or NPH insulin as basal insulin therapy in type 1 diabetes

MeasureGroup 1Group 2Mean difference (95% CI)P
HbA1c (%)IDetcombinedNPH−0.2 (−0.34 to −0.02)0.027
Clinic FPG (mmol/l)IDet12hNPH−1.5 (−2.51 to −0.48)0.004
IDetmorn+bedNPH−2.3 (−3.32 to −1.29)<0.001
IDet12hIDetmorn+bed0.8 (−0.18 to 1.80)NS
Self-monitored fasting blood glucose
 MeanIDet12hNPH−0.8 (−1.32 to −0.22)0.006
IDetmorn+bedNPH−0.8 (−1.34 to −0.25)0.004
IDet12hIDetmorn+bed0.0 (−0.51 to 0.56)NS
 Within-patient SD*IDet12hNPH<0.001
IDetmorn+bedNPH<0.001
IDet12hIDetmorn+bedNS
Body weight change (kg)IDet12hNPH−0.8 (−1.44 to −0.24)0.006
IDetmorn+bedNPH−0.6 (−1.23 to −0.03)0.040
IDet12hIDetmorn+bed−0.2 (−0.80 to 0.37)NS
CGMS glucose profiles deviation from average (mmol/l · h)
 >24 hIDetcombinedNPH−6.45 (−13.3 to 0.40)0.065
 OvernightIDetcombinedNPH−1.72 (−4.05 to −0.62)NS
Hypoglycemia in final 12 weeks [RR (95% CI)]
 Minor-any timeIDet12hNPH0.75 (0.56–1.00)0.046
IDetmorn+bedNPH0.68 (0.56–0.84)0.002
 Minor-nocturnalIDet12hNPH0.74 (0.50–1.08)NS
IDetmorn+bedNPH0.47 (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.