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Insulin Detemir Offers Improved Glycemic Control Compared With NPH Insulin in People With Type 1 Diabetes

A randomized clinical trial

¹ University of Newcastle Upon Tyne, Newcastle Upon Tyne, U.K
² Stoneham Chambers, Stones Corner, Australia
³ Royal Surrey County Hospital, Guildford, U.K
⁴ University Hospital, Toulouse, France
⁵ Isala Clinic, Location Sophia, Zwolle, the Netherlands
⁶ University Hospital, Antwerp, Edegem, Belgium
⁷ Lund University Hospital, Lund, Sweden
⁸ Novo Nordisk, Gladsaxe, Denmark

Address correspondence and reprint requests to Prof. Philip Home, Department of Diabetes and Metabolism, Framlington Place, Newcastle Upon Tyne, NE2 4HH, U.K. E-mail: philip.home{at}newcastle.ac.uk

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_1c, 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 the 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% CI –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), as was self-measured prebreakfast plasma glucose (P = 0.006 and P = 0.004, respectively). The risk of minor hypoglycemia was lower in both insulin detemir groups (25%, P = 0.046; 32%, P = 0.002; respectively) 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 compared with NPH insulin. The data provide a basis for tailoring the timing of administration of insulin detemir to the individual person’s needs.

Abbreviations: CGMS, continuous glucose monitoring system • FPG, fasting plasma glucose

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