1. 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
- Author
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Svein Skeie, J. W. F. Elte, J.-L. Selam, I. De Leeuw, H. Lang, Eberhard Draeger, and Philippe Vague
- Subjects
Adult ,Blood Glucose ,Male ,medicine.medical_specialty ,endocrine system diseases ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,Insulin, Isophane ,NPH insulin ,Lower risk ,Drug Administration Schedule ,Insulin aspart ,Endocrinology ,Insulin Detemir ,Internal medicine ,Diabetes mellitus ,Internal Medicine ,medicine ,Humans ,Insulin ,Insulin detemir ,Glycated Hemoglobin ,Type 1 diabetes ,business.industry ,Body Weight ,nutritional and metabolic diseases ,medicine.disease ,Insulin, Long-Acting ,Diabetes Mellitus, Type 1 ,Basal (medicine) ,Female ,Human medicine ,business ,hormones, hormone substitutes, and hormone antagonists ,medicine.drug - Abstract
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
- Published
- 2005