التفاصيل البيبلوغرافية
| العنوان: |
Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients—The PREDICTIVE™ BMI clinical trial. |
| المؤلفون: |
Montañana, C. Fajardo1 CFajardo@Hospital-Ribera.com, Herrero, C. Hernández2, Fernández, M. Rivas3 |
| المصدر: |
Diabetic Medicine. Aug2008, Vol. 25 Issue 8, p916-923. 8p. 1 Diagram, 4 Charts, 2 Graphs. |
| مصطلحات موضوعية: |
*CLINICAL trials, *WEIGHT gain, *HYPOGLYCEMIA, *INSULIN therapy, *DOSE-effect relationship in pharmacology, *OVERWEIGHT persons, *PEOPLE with diabetes |
| مستخلص: |
Objective To assess weight change when once-daily insulin detemir (detemir) or neutral protamine Hagedorn insulin (NPH) are used in already overweight Type 2 diabetes patients requiring intensified insulin therapy. Research design and methods This 26-week randomized, controlled trial included adults with Type 2 diabetes [glycated haemoglobin (HbA1c) 7.5–11.0%, body mass index (BMI) 25–40 kg/m2] who had received two daily doses of insulin (at least one a premix) for ≥ 3 months. Subjects received either detemir ( n = 125) or NPH ( n = 146) once daily in the evening and insulin aspart at main meals. Concomitant treatment with metformin was allowed. Basal insulin was titrated to a pre-breakfast plasma glucose target of 6.1 mmol/l without unacceptable hypoglycaemia. Insulin aspart was also titrated (target, postprandial glucose ≤ 10.0 mmol/l without unacceptable hypoglycaemia). Results At 26 weeks, weight had increased significantly less with detemir (0.4 kg) than with NPH (1.9 kg; difference 1.5 kg, P < 0.0001). BMI increase was also less with detemir than with NPH (difference 0.6 kg/m2, P < 0.0001). HbA1c decreased from 8.9 to 7.8% (detemir) and from 8.8 to 7.8% (NPH; not significant for between-treatment difference). Incidence of hypoglycaemia was lower with detemir [relative risks 0.62 (all events) and 0.43 (nocturnal); P < 0.0001 for both]. Conclusions PREDICTIVE™ BMI was the first study to examine the effect of once-daily detemir with weight as the primary endpoint in a large population of overweight Type 2 diabetes patients. Use of once-daily detemir for intensification of insulin therapy resulted in less weight gain, less hypoglycaemia and equivalent glycaemic control compared with NPH. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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