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

Assessment of Detemir Administration in a Progressive Treat-To-Target Trial (ADAPT)

  1. Jean-Pierre Le Floch, MD1,
  2. Marc Lévy, MD2,
  3. Helen Mosnier-Pudar, MD3,
  4. Frank Nobels, MD4,
  5. Sylvie Laroche, MD5,
  6. Sophie Gonbert, MD, PHD5,
  7. Eveline Eschwege, MD, PHD6,
  8. Pierre Fontaine, MD7 and
  9. The Assessment of Detemir Administration in a Progressive Treat-to-Target Trial (ADAPT) Study Group
  1. 1Medical Clinic, Villecresnes, France
  2. 2Max Fourestier Hospital, Nanterre, France
  3. 3Cochin Hospital, Paris, France
  4. 4OL Vrouwziekenhuis Hospital, Aaslt, Belgium
  5. 5Novo Nordisk Pharmaceutics, Paris, France
  6. 6Institut National de la Santé et de la Recherche Médicale U780, Villejuif, France
  7. 7Clinique Marc Linquette, Lille, France
  1. Corresponding author: J.P. Le Floch, jplefloch{at}dietvill.com

Abstract

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.

Footnotes

  • Published ahead of print at http://care.diabetesjournals.org on 22 October 2008. Clinical trial reg. no. NCT00117780, clinicaltrials.gov.

    Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

    The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.

    • Accepted October 10, 2008.
    • Received February 4, 2008.
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  1. Published online before print October 22, 2008, doi: 10.2337/dc08-0332 Diabetes Care January 2009 vol. 32 no. 1 32-37
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