Insulin Detemir Offers Improved Glycemic Control Compared With NPH Insulin in People With Type 1 Diabetes
A randomized clinical trial
Article Figures & Tables
Figures
- Figure 1—
Mean 10-point self-measured plasma glucose profiles after 16 weeks of treatment with insulin detemir or NPH insulin as basal insulin. Arrows indicate time of first and second basal insulin dose. IDet12h (•—•), insulin detemir administered at 12-h intervals; IDetmorn+bed (• - - •), insulin detemir administered morning and bedtime; NPH (○—○), NPH insulin morning and bedtime.
Tables
- Table 1—
Baseline characteristics of the people randomized and receiving treatment
IDet12h IDetmorn+bed NPH n 137 139 132 Age (years) 40.9 ± 13.0 41.3 ± 11.4 38.3 ± 12.4 Sex (M/F) 71/66 79/60 70/62 Weight (kg) 74.2 ± 12.6 75.0 ± 12.3 75.5 ± 14.0 BMI (kg/m2) 25.1 ± 3.3 25.2 ± 3.6 25.2 ± 3.7 Diabetes duration (years) 17.1 ± 10.6 17.6 ± 10.7 15.1 ± 10.6 FPG (mmol/l) 11.57 ± 4.65 11.65 ± 4.61 12.20 ± 5.49 HbA1c 8.55 ± 1.20 8.74 ± 1.20 8.52 ± 1.19 Insulin dose (units/day)* Basal 26.4 ± 10.8 28.1 ± 12.5 29.5 ± 13.7 Mealtime 30.9 ± 12.9 29.4 ± 13.4 30.5 ± 13.4 Data are means ± SD.
- *
↵* Does not include people using premix insulin at study start.
- Table 2—
Outcome measures using insulin detemir or NPH insulin as basal insulin therapy in type 1 diabetes
IDet12h IDetmorn+bed NPH P HbA1c (%) 7.75 ± 0.07 7.78 ± 0.07 7.94 ± 0.07 0.082 Clinic FPG (mmol/l) 9.75 ± 0.37 8.94 ± 0.37 11.24 ± 0.38 <0.001 Self-monitored prebreakfast plasma glucose (mmol/l) Mean 8.28 ± 0.20 8.26 ± 0.20 9.05 ± 0.21 0.005 Within-patient SD 2.95 (2.80–3.10) 2.91 (2.76–3.05) 3.49 (3.31–3.68) <0.001 Body weight change (kg) 0.02 ± 0.22 0.24 ± 0.22 0.86 ± 0.23 0.018 CGMS glucose profiles deviation from average (mmol/l · h) >24 h 54.9 ± 2.95 63.7 ± 2.92 59.7 ± 2.92 0.092 Overnight 15.9 ± 0.98 17.7 ± 1.01 16.2 ± 1.00 NS Hypoglycemia in final 12 weeks Minor Anytime n (%) 114 (84) 114 (83) 107 (84) Events 842 780 1,074 0.020 Nocturnal n (%) 59 (44) 47 (34) 64 (50) Events 125 82 166 0.002 Major Anytime n (%) 6 (4) 11 (8) 10 (8) Events 9 24 12 NS Nocturnal n (%) 3 (2) 5 (4) 4 (3) Events 4 9 4 NS Insulin dose (units/day) Basal 36.7 ± 16.4 36.3 ± 16.5 34.8 ± 13.5 NS Mealtime 27.9 ± 15.0 29.4 ± 12.2 29.4 ± 12.5 NS Data are means ± SE, estimate (95% CI) for within-patient SD, mean ± SD for insulin doses, or n (%). n = 130–132 for the IDet12h group, n = 131–135 for the IDetmorn+bed group, and n = 119–125 for the NPH group, except for GCMS, where n = 58–60 for 24 h and 62–69 for overnight. Differences and confidence intervals for pairs of treatments are given in Table 3. n for hypoglycemia is number of people having at least one episode. P value for ANOVA comparison of the three treatment groups together.
- Table 3—
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.
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