Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial

Jenny Lind Children's Department, Norfolk and Norwich University Hospital, Norwich, UK.
Diabetic Medicine (Impact Factor: 3.06). 10/2012; 30(2). DOI: 10.1111/dme.12041
Source: PubMed

ABSTRACT AIMS: This 52-week, randomized, multinational, open-label, parallel-group, non-inferiority trial investigated the efficacy and safety of basal-bolus treatment with insulin detemir vs. NPH (neutral protamine Hagedorn) insulin, in combination with insulin aspart, in subjects aged 2-16 years with Type 1 diabetes mellitus. METHODS: Of the 347 randomized and exposed subjects, 177 received insulin detemir and 170 NPH insulin, both administered once or twice daily in combination with mealtime insulin aspart. Glycaemic measurements and weight were followed over 52 weeks. RESULTS: After 52 weeks, insulin detemir was shown to be non-inferior to NPH insulin with regard to HbA(1c) [mean difference insulin detemir-NPH: 1.30 mmol/mol, 95% CI -1.32 to 3.92 (0.12%, 95% CI -0.12 to 0.36) in the full analysis set and 1.41 mmol/mol, 95% CI -1.26 to 4.08 (0.13%, 95% CI -0.12 to 0.37) in the per protocol analysis set]. Hypoglycaemic events per subject-year of exposure of 24-h and nocturnal hypoglycaemia were significantly lower with insulin detemir than with NPH insulin (rate ratio 0.76, 95% CI 0.60-0.97, P = 0.028 and 0.62, 95% CI 0.47-0.84, P = 0.002, respectively). Weight standard deviation (sd) scores (body weight standardized by age and gender) decreased with insulin detemir, but increased slightly with NPH insulin (change: -0.12 vs. 0.04, P < 0.001). At end of the trial, median insulin doses were similar in both treatment groups. CONCLUSIONS: Insulin detemir was non-inferior to NPH insulin after 52 weeks' treatment of children and adolescents aged 2-16 years, and was associated with a significantly lower risk of hypoglycaemia, together with significantly lower weight sd score when compared with NPH insulin. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

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    ABSTRACT: Introduction: Diabetes mellitus is a frequent endocrine disease during childhood and adolescence. Achieving a good glycemic control is of paramount importance to avoid short- and long-term complications and to allow a normal growth and quality of life. Areas covered: This review offers an update on current available treatment strategies for type 1 and type 2 diabetes approved for use in children and adolescents. Expert opinion: Although many progresses have been made in the field of diabetes management in children and adolescents, there are still several problems to deal with. With regard to type 1 diabetes, insulin remains the main and essential therapeutic strategy. However, the main issue is to develop a system that allows more physiological insulin coverage and reduces the risk of hypoglycemia and weight gain. Adjunct therapies would be invaluable for patients struggling to achieve an acceptable glycemic control. Treatment of type 2 diabetes is based on lifestyle interventions and metformin is the first-line drug for children older than 10 years. As for type 1 diabetes, there is a strong need for developing new drugs to be used alone or in combination.
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    ABSTRACT: Background/Aim. An ideal insulin regimen for children and adolescents with type 1 diabetes mellitus (T1DM) should be physiological, flexibile and predictable, protecting against hypoglycaemia. The aim of this study was to evaluate the influence of insulin analogues on glycaemic control and the occurrace of of hypoglycaemic episodes in children and adolescents with T1DM. Methods. The study group consisted of 151 children and adolescents (90 boys, 61 girls) treated with human insulins for at least 12 months before introducing insulin analogues. All the patients were divided into two groups: the group I consisted of 72 (47.7%) patients treated with three injections of regular human insulin before meals and long-acting analogue (RHI/LA), and the group II of 79 (52.3%) patients treated with a combination of rapid-acting and long-acting analogue (RA/LA). The levels of glycated hemoglobin (HbA1c) and the number of hypoglycaemic episodes were assessed at the beginning of therapy with insulin analogues, and after 6 and 12 months. Results. The mean HbA1c was significantly lower in the group I (RHI/LA) after 6 months (9.15% vs 8.20%, p < 0.001) and after 12 months (9.15% vs 8.13%,p <0.001) as well as in the group II (RA/LA) after 6 months (9.40% vs 8.24%, p < 0.001) and after 12 months of insulin analogues treatment (9.40% vs 8.38%,p < 0.001). The frequency of severe hypoglycaemia was significantly lower in both groups after 6 months ((an the group I from 61.1% to 4.2% and in the group II from 54.4% to 1.3%,p < 0.001), and after 12 months (in the group I from 61.1% to 1.4% and in the group II from 54.4% to 1.3%, p < 0.001). Conclusion. Significantly better HbA1c values and lower risk of severe hypoglycaemia were established in children and adolescents with T1DM treated with insulin analogues.
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