Insulin Detemir Noninferior to NPH Insulin for Children With Type 1 Diabetes: Presented at EASD
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Insulin Detemir Noninferior to NPH Insulin for Children With Type 1 Diabetes: Presented at EASD

By Bruce Sylvester

VIENNA, Austria -- October 6, 2009 -- Children and adolescents aged 2 to 16 years treated for type 1 diabetes for 1 year with insulin detemir have achieved glycaemic control similar to those treated with Neutral Protamine Hagedorn (NPH) insulin, but they achieved significantly lower risk of overall and nocturnal hypoglycaemia and a reduction in weight.

Nandu Thalange, Norfolk and Norwich University Hospital, Norwich, United Kingdom, presented the results of a large, randomised study during a poster presentation on September 30 at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD).

“Exceptionally, nearly a quarter of participants were under 6 years of age,” said Dr. Thalange. “The aim of the study was to compare the efficacy and safety of insulin detemir and NPH insulin in this vulnerable and important age group, after 1 year of treatment.”

For the study, the researchers randomised 347 patients (mean age, 9.9 years) to receive either insulin detemir (n = 177) or NPH insulin (n = 170), both administered once or twice daily in combination with mealtime insulin aspart for 52 weeks.

Change in mean fasting plasma glucose (FPG) was -0.60 mmol/L with insulin detemir, compared with 0.02 mmol/L with NPH insulin, a nonsignificant difference. However, patient self-measured FPG was significantly lower with insulin detemir than with NPH insulin (3.01 vs 3.68 mmol/L; P < .001).

Estimated mean rate of 24-hour hypoglycaemia and nocturnal hypoglycaemia were lower with insulin detemir than with NPH insulin. For 24-hour hypoglycaemia the rates were 55.4 events per exposure year for insulin detemir versus 72.5 events per exposure year for NPH insulin (P < .05). For nocturnal hypoglycaemia, the rates were 8.7 events per exposure year for insulin detemir versus 13.9 events per exposure year for NPH insulin (P < .005).

Severe hypoglycaemic episodes were rare (3 with insulin detemir and 12 with NPH insulin). None occurred at night with insulin detemir.

Notably, standard deviation scores for body weight decreased with insulin detemir treatment and remained unchanged with NPH insulin treatment (P < .001).

Funding for this study was provided by Novo Nordisk A/S.

[Presentation title: Comparison of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes Mellitus Aged 2-16 Years: A 52-Week Randomised Clinical Trial. Abstract 985]

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