Premium
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 1
Author(s) -
Montañana C. Fajardo,
Herrero C. Hernández,
Fernández M. Rivas
Publication year - 2008
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2008.02483.x
Subject(s) - insulin detemir , medicine , insulin aspart , nph insulin , endocrinology , insulin , type 2 diabetes , overweight , postprandial , body mass index , evening , diabetes mellitus , insulin glargine , physics , astronomy
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 (HbA 1c ) 7.5–11.0%, body mass index (BMI) 25–40 kg/m 2 ] 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/m 2 , P < 0.0001). HbA 1c 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.