A Comparison of Postprandial and Preprandial Administration of Insulin Aspart in Children and Adolescents With Type 1 Diabetes
- Thomas Danne, MD1,
- Jan Aman, MD2,
- Edith Schober, MD3,
- Dorothee Deiss, MD4,
- Judith L. Jacobsen, MSC5,
- Hans Henrik Friberg, MSC5,
- Lars Hein Jensen, MSC PHARM5 and
- the ANA 1200 Study Group
- 1Kinderkrankenhaus auf der Bult, Diabetes-Zentrum für Kinder und Jugendliche, Hannover, Germany
- 2Department of Paediatrics, (Barn och Ungdomskliniken), Regional Hospital, Örebro, Sweden
- 3Universitätsklinik für Kinder- und Jugendheilkunde, Wien, Austria
- 4Klinik für Allgemeine Pädiatrie, Charité, Campus Virchow-Klinikum, Berlin, Germany
- 5Novo Nordisk A/S, Bagsvaerd, Denmark
- Address correspondence and reprint requests to Thomas Danne, MD, Kinderkrankenhaus auf der Bult, Diabetes-Zentrum für Kinder und Jugendliche, Janusz-Korczak-Allee 12, 30173 Hannover, Germany. E-mail: danne{at}hka.de
Abstract
OBJECTIVE—The aim of this study was to compare the glycemic control of preprandial versus postprandial injections of the new rapid-acting insulin analogue aspart in children and adolescents with type 1 diabetes.
RESEARCH DESIGN AND METHODS—Forty-two children (aged 6–12 years) and 34 adolescents (13–17 years) were randomized to preprandial (immediately before meal start) and postprandial (immediately after a meal or a maximum of 30 min after meal start) treatment with insulin aspart (at least thrice daily) as part of a basal/bolus regimen in a multicenter study with an open labeled, two-period cross-over design (6-week periods). Of this group, 49% were boys, 55% were aged ≤13 years, and duration of diabetes was 4.4 years (range 1.0–9.4).
RESULTS—Glycemic control for postprandial treatment was not worse than preprandial treatment as assessed by fructosamine week 0 vs. 6 (mean ± SD, preprandial 367 ± 74 vs. 378 ± 90 μmol/l; postprandial 383 ± 83 vs. 385 ± 77 μmol/l) and HbA1c (preprandial 7.9 ± 1.3 vs. 8.0 ± 1.5%; postprandial 8.0 ± 1.4 vs. 8.3 ± 1.5%, P = 0.14). The only statistically significant finding from the seven-point blood glucose profiles and derived parameters between preprandial and postprandial treatment was a lower postprandial glucose level 120 min after breakfast (mean ± SEM, −2.08 ± 0.74 mmol/l, P = 0.016). The relative risk of hypoglycemia (blood glucose <3.9 mmol/l) preprandially to postprandially was not significantly different (mean 1.1; 95% CI 0.91–1.35; P = 0.31). Overall treatment satisfaction was equally high for both regimens with both patients and parents.
CONCLUSIONS—Although preprandial administration of insulin aspart is generally preferable, this study shows that in children and adolescents, postprandial administration of insulin aspart is a safe and effective alternative.
- AE, adverse event
- DTSQ, Diabetes Treatment Satisfaction Questionnaire
- IAsp post, postprandial administration of insulin aspart
- IAsp pre, preprandial administration of insulin aspart
- PP, per protocol
Footnotes
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A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
T.D. has received honoraria for speaking engagements from several companies involved in the diabetes field and has received grant support from Abbott MediSense, Aventis, Bayer, Disetronic, Lifescan, Lilly, Medtronic Minimed, Menarini, NovoNordisk, and Pharmacia for research or scientific meetings; E.S. received a consultation fee from NovoNordisk for each participating patient; J.L.J., H.H.F., and L.H.J. are employed by Novo Nordisk A/S, who manufactures and markets pharmaceuticals related to the treatment of diabetes and its complications; and J.L.J. and H.H.F. personally or an immediate family member holds stock in Novo Nordisk A/S.
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- Accepted May 1, 2003.
- Received September 18, 2002.
- DIABETES CARE
