Abstract

Objective: To compare insulin detemir OD vs. BID in a basal–bolus insulin regimen.

Research Design and Methods: This open-label, 7-month study randomized 520 patients with type 1 diabetes to receive detemir OD or BID, with mealtime insulin aspart. Insulins were titrated over 1 month, with patients followed-up over the subsequent 3 months. Thereafter, patients were able to switch from one regimen to the other, with an additional non-randomized 3-month follow-up, to a total of 7 months. The primary endpoint was HbA_1c at 4 months, with non-inferiority defined as a difference <0.4% between groups.

Results: HbA_1c at 4 months was 8.1±0.9 vs. 8.0±1.0% with OD and BID detemir, respectively, with an adjusted between-group difference of 0.12% (95% CI –0.01; 0.25%), showing non-inferiority for OD dosing. Similar results were found in the per protocol population. Improvement in HbA_1c was similar in both groups (–0.4±0.8 vs. –0.5±0.8%; P=0.09, NS), but with differences in the 7-point glucose profile. Detemir doses were lower (29±18 vs. 39±20 U/d, P<0.001), but aspart doses higher (34±17 vs. 26±14 IU/d, P<0.001) with OD detemir. At 7 months, HbA_1c decreased slightly in patients switched from OD to BID (8.2±0.8 vs. 8.0±0.8%; P=0.34, NS) in association with increased total insulin doses (P<0.05) but HbA_1c increased in those switched from BID to OD (7.2±0.9 vs. 7.6±0.8%; P<0.05) in association with decreased doses (P<0.05).

Conclusions: While some individuals may benefit from BID dosing, the most suitable routine starting schedule for detemir in a basal–bolus regimen for type 1 diabetes is OD injection.