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

Authors: Montañana, C. Fajardo; Herrero, C. Hernández¹; Fernández, M. Rivas²

Source: Diabetic Medicine, Volume 25, Number 8, August 2008 , pp. 916-923(8)

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Abstract:

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/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). 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.

Diabet. Med. 25, 916-923 (2008)

Keywords: body weight; detemir; insulin; obesity; Type 2 diabetes

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1464-5491.2008.02483.x

Affiliations: 1: Endocrinology, Hospital Virgen de Macarena, Seville and 2: Endocrinology, Hospital Infanta Luisa, Seville, Spain

Publication date: 2008-08-01