Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes - A randomized clinical trial

OBJECTIVE-Insulin detemir is a soluble long-acting basal insulin analog designed to overcome the limitations of conventional basal insulin formulations. Accordingly, insulin detemir has been compared with NPH insulin with respect to glycemic control (HbA(lc), prebreakfast glucose levels and variability, and hypoglycemia) and timing of administration. RESEARCH DESIGN AND METHODS - People with type 1 diabetes (n - 408) were randomized in an open-label, parallel-group trial of 16-week treatment duration using either insulin detemir or NPH insulin. Insulin detemir was administered twice daily using two different regimens, either before breakfast and at bedtime (IDet(morn +bed)) or at a 12-h interval (IDet(12h)) NPH insulin was administered before breakfast and at bedtime. Mealtime insulin was given as rapid-acting insulin analog insulin aspart. RESULTS - With both insulin detemir groups, clinic fasting plasma glucose was lower than with NPH insulin (IDet(12h) vs. NPH, -1.5 mmol/l [95% Cl -2.51 to -0.48], P = 0.004; IDet(morn + bed) vs NPH, -2.3 mmol/l (-3.32 to -1.29), P < 0.001), is was self-measured prebreakfast plasma glucose (P = 0.006 and P = 0.004, respectively) The risk of minor hypo-glycemia was lower in both insulin detemir groups (25%, P = 0.0461 32%, P = 0.002, respeclively) compared with NPH insulin in the last 12 weeks of treatment, this being mainly attributable to a 53% reduction in nocturnal hypoglycemia in the IDet(morn+bed) group (P < 0.001). Although HbA(1c) for each insulin detemir group Was not different from the NPH group, HbA(1c) for the pooled insulin detemir groups was significantly lower than for the NPH group (mean difference -0.18% [-0.34 to -0.02], P = 0.027). Within-person between-day variation in self-measured prebreakfast plasma glucose was lower for both detemir groups (both P < 0.001). The NPH group gained weight during the study, but there was no change in weight in either of the insulin detemir groups (IDet(12h) vs. NPH, -0.8 kg \ -1.44 to -0.24], P = 0.006 IDet(morn + bed) vs NPH, -0.6 kg [- 1.23 to -0.03], P = 0.040). CONCLUSIONS - Overall glycemic control with insulin detemir was improved compare with NPH insulin. The data provide a basis for tailoring the timing of administration of insulin detemir to the individual person's needs.