Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2005-01, Vol.7 (1), p.73-82
• Main Authors: De Leeuw, I., Vague, P., Selam, J.-L., Skeie, S., Lang, H., Draeger, E., Elte, J. W. F.
• Format: Article
• Language: English
• Subjects: Adult; basal-bolus therapy; Blood Glucose - analysis; Blood Glucose - metabolism; Body Weight - drug effects; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Drug Administration Schedule; Female; Glycated Hemoglobin A - analysis; Humans; Insulin - administration & dosage; Insulin - analogs & derivatives; Insulin - therapeutic use; Insulin Detemir; Insulin, Isophane - administration & dosage; Insulin, Isophane - therapeutic use; Insulin, Long-Acting; Male; nocturnal hypoglycaemia; NPH insulin; type 1 diabetes
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/j.1463-1326.2004.00363.x

Aim:  The aim of this study was to compare the long‐term safety and efficacy of twice‐daily insulin detemir or NPH insulin as the basal component of basal‐bolus therapy in people with type 1 diabetes. Methods:  A multicentre, open‐label, parallel‐group study was conducted over 12 months and completed by 308 people (from an original randomized cohort of 428). Patients were randomized in a 2 : 1 ratio to receive insulin detemir or NPH insulin before breakfast and dinner, with insulin aspart at mealtimes. Results:  Glycaemic control improved in both groups with HbA1c decreasing by 0.64 and 0.56% point in the insulin detemir and NPH insulin groups, reaching baseline‐adjusted final values of 7.53 ± 0.10% and 7.59 ± 0.13%, respectively. No significant difference was apparent between treatments in terms of HbA1c, fasting plasma glucose or 9‐point blood glucose profiles. Fewer hypoglycaemic events (major and minor) occurred in association with insulin detemir compared with NPH insulin, but the overall hypoglycaemic risk did not differ statistically significantly (RR for detemir, 0.78 [0.56–1.08]). However, the risk of nocturnal hypoglycaemia during the maintenance phase (month 2–12) was 32% lower in the detemir group (p = 0.02) and lower in every month. This risk reduction remained statistically significant after correction for HbA1c. After 12 months, baseline‐adjusted mean body weight was significantly lower in the insulin detemir group than in the NPH insulin group (p