Comparison of Once- Versus Twice-Daily Administration of Insulin Detemir, Used With Mealtime Insulin Aspart, in Basal-Bolus Therapy for Type 1 Diabetes

Diabetes Care - Tập 32 Số 1 - Trang 32-37 - 2009
Jean‐Pierre Le Floch1, Marc Lévy2, Helen Mosnier-Pudar3, Frank Nobels4, Sylvie Laroche5, Sophie Gonbert5, Eveline Eschwège6, P. Fontaine7
1Medical Clinic, Villecresnes, France
2Max Fourestier Hospital, Nanterre, France
3Cochin Hospital, Paris, France
4OL Vrouwziekenhuis Hospital, Aaslt, Belgium
5Novo Nordisk Pharmaceutics, Paris, France
6Institut National de la Santé et de la Recherche Médicale U780, Villejuif, France
7Clinique Marc Linquette, Lille, France

Tóm tắt

OBJECTIVE—The purpose of this study was to compare effects of insulin detemir once daily versus twice a day in a basal-bolus insulin regimen. RESEARCH DESIGN AND METHODS—In this open-label, 7-month study, 520 patients with type 1 diabetes were randomly assigned to receive detemir once daily or twice daily with mealtime insulin aspart. Insulin doses 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 nonrandomized 3-month follow-up, to a total of 7 months. The primary end point was A1C at 4 months, with noninferiority defined as a difference <0.4% between groups. RESULTS—A1C at 4 months was 8.1 ± 0.9 versus 8.0 ± 1.0% with once- and twice-daily detemir, respectively, with an adjusted between-group difference of 0.12% (95% CI −0.01 to 0.25%), showing noninferiority for once-daily dosing. Similar results were found in the per protocol population. Improvement in A1C 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 units/day, P < 0.001), but aspart doses were higher (34 ± 17 vs. 26 ± 14 IU/day, P < 0.001) with once-daily detemir. At 7 months, A1C decreased slightly in patients switched from once-daily to twice-daily administration (8.2 ± 0.8 vs. 8.0 ± 0.8%; P = 0.34, NS) in association with increased total insulin doses (P < 0.05), but A1C increased in those switched from twice-daily to once-daily administration (7.2 ± 0.9 vs. 7.6 ± 0.8%, P < 0.05) in association with decreased doses (P < 0.05). CONCLUSIONS—Although some individuals may benefit from twice-daily dosing, the most suitable routine starting schedule for detemir in a basal-bolus regimen for type 1 diabetes is once-daily injection.

Từ khóa


Tài liệu tham khảo

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Diabetes Care

Tập 32 Số 1

32-37

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