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

Autor: Abdullah Bereket, Valentina Alexandrovna Peterkova, Line Conradsen Hiort, Jens Larsen, Nandu Thalange
Přispěvatelé: Thalange, N., Bereket, A., Larsen, J., Hiort, L. C., Peterkova, V.
Jazyk: angličtina
Rok vydání: 2013
Předmět:
Blood Glucose
Male
endocrine system diseases
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
Insulin
Isophane
NPH insulin
MICROVASCULAR COMPLICATIONS
THERAPY
law.invention
Body Mass Index
Endocrinology
Randomized controlled trial
Insulin Detemir
law
BASAL-BOLUS REGIMEN
GLYCEMIC CONTROL
Child
Research Articles
Insulin detemir
DETEMIR
BLOOD-GLUCOSE CONTROL
NEUTRAL PROTAMINE HAGEDORN
Europe
Insulin
Long-Acting
NPH INSULIN
Treatment Outcome
Child
Preschool
Female
medicine.drug
medicine.medical_specialty
Adolescent
Lower risk
Drug Administration Schedule
Insulin aspart
HYPOGLYCEMIA
PEOPLE
Internal medicine
Diabetes mellitus
Internal Medicine
medicine
Humans
Hypoglycemic Agents
Insulin Aspart
Glycated Hemoglobin
Type 1 diabetes
business.industry
Insulin
Body Weight
nutritional and metabolic diseases
medicine.disease
Diabetes Mellitus
Type 1
business
Zdroj: Diabetic Medicine
Popis: Aims This 52-week, randomized, multinational, open-label, parallel-group, non-inferiority trial investigated the efficacy and safety of basalbolus treatment with insulin detemir vs. NPH (neutral protamine Hagedorn) insulin, in combination with insulin aspart, in subjects aged 216 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 HbA1c [mean difference insulin detemirNPH: 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 0.600.97, P = 0.028 and 0.62, 95% CI 0.470.84, 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 216 years, and was associated with a significantly lower risk of hypoglycaemia, together with significantly lower weight sd score when compared with NPH insulin. Diabet. Med. 30, 216-225 (2013)
Databáze: OpenAIRE
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