Lower Within-Subject Variability of Insulin Detemir in Comparison to NPH Insulin and Insulin Glargine in People With Type 1 Diabetes

Diabetes - Tập 53 Số 6 - Trang 1614-1620 - 2004
Tim Heise1, Leszek Nosek1, Birgitte Rønn2, Lars Endahl2, Lutz Heinemann1, Christoph Kapitza1, E. Draeger2
1Profil Institut für Stoffwechselforschung, Neuss, Germany
2Novo Nordisk, Bagsværd, Denmark

Tóm tắt

The aim of this randomized double-blind study was to compare the within-subject variability of the glucose-lowering effect of a novel insulin analog, insulin detemir, with that of insulin glargine and NPH insulin in people with type 1 diabetes. Fifty-four subjects (32 males and 22 females, age 38 ± 10 years [mean ± SD], BMI 24 ± 2 kg/m2, HbA1c 7.5 ± 1.2%, diabetes duration 18 ± 9 years) participated in this parallel group comparison. Each subject received four single subcutaneous doses of 0.4 units/kg of either insulin detemir (n = 18), insulin glargine (n = 16), or human NPH insulin (n = 17) under euglycemic glucose clamp conditions (target blood glucose concentration 5.5 mmol/l) on four identical study days. The pharmacodynamic (glucose infusion rates [GIRs]) and pharmacokinetic (serum concentrations of insulin detemir, human insulin, and insulin glargine) properties of the basal insulin preparations were recorded for 24 h postdosing. Insulin detemir was associated with significantly less within-subject variability than both NPH insulin and insulin glargine, as assessed by the coefficient of variation (CV) for the pharmacodynamic end points studied [GIR-AUC(0–12 h) 27% (detemir) vs. 59% (NPH) vs. 46% (glargine); GIR-AUC(0–24 h) 27 vs. 68 vs. 48%; GIRmax 23 vs. 46 vs. 36%; P < 0.001 for all comparisons]. Insulin detemir also provided less within-subject variability in the pharmacokinetic end points: maximal concentration (Cmax) 18 vs. 24 vs. 34%; INS-AUC(0–∞) 14 vs. 28 vs. 33%. The results suggest that insulin detemir has a significantly more predictable glucose-lowering effect than both NPH insulin and insulin glargine.

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Diabetes

Tập 53 Số 6

1614-1620

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