Lege Artis Medicinae

[Switching from human basal insulin to once daily insulin detemir in type 2 diabetic patients treated by basal-bolus regimen - Results from the LEONCET2, an observational, prospective, multicenter study]

JEMENDY György1

FEBRUARY 20, 2010

Lege Artis Medicinae - 2010;20(02)

[Insulin analogues have been developed in order to overcome some drawbacks of human insulins. Switching from a human insulin-based basal- bolus regimen to once daily detemir could result in improved metabolism and increased safety of the therapy. We assessed the effects of switching from human NPH-insulin to once daily detemir insulin in patients with type 2 diabetes mellitus treated with a basal-bolus insulin regimen. We evaluated the data of 1,474 patients with diabetes (age: 59.1±9.8 years, body weight 89.6±8.6 kg, BMI 31.6±5.4 kg/m2) in an observational, prospective, 24-week, multicenter study. All patients were treated with a basal-bolus regimen consisting of human NPH as basal insulin and a human or analogue insulin as bolus insulin. After enrollment, patients received once daily detemir insulin instead of NPH-insulin, while treatment with bolus insulin was continued. Patients were examined at weeks 12 and 24. By week 24, the mean HbA1c value, irrespective of BMI-categories, decreased significantly (p<0.0001) from 8.63±1.01% by 0.79±0.63%. Fasting blood glucose level decreased from 8.86±1.78 mmol/l to 7.09±1.31 mmol/l; p<0.0001). The target level of HbA1c (<7.0%) was reached by 194 patients (13.1%). The patients’ body weight decreased significantly by week 12 (-0.69±2.00 kg; p<0.0001) and by week 24 (-1.28±2.80 kg; p<0.0001). The changes were more pronounced in higher than in lower BMI-categories (p for trend <0.0001). The mean daily doses of basal insulin were increased from 0.28 IU/kg to 0.33 IU/kg while those of bolus insulins were not changed. The rate of severe hypoglycaemic events decreased significantly (p=0.048) from 2.95 [daytime 1.02, nocturnal 1.93] to 0.06 [daytime 0.04, nocturnal 0.02] episodes/patient-year. In patients with type 2 diabetes mellitus treated with basal-bolus regimen, switching from human basal insulin to once daily insulin detemir results in a significantly improved metabolism, as well as fewer hypoglycaemic events and decreased body weight. Nevertheless, the low rate of patients reaching the glycaemic target implicates that some factors other than an appropriate basal insulin substitution have a role in achieving an optimal metabolic control.]

AFFILIATIONS

  1. Bajcsy-Zsilinszky Kórház, III. Belgyógyászati Osztály

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