INSULIN DETEMIR IN ROUTINE CLINICAL PRACTICE: A 26-WEEK FOLLOW-UP IN TYPE 1 DIABETIC PATIENTS FROM THE BELGIAN PREDICTIVE COHORT

Abstract

Aim - PREDICTIVE (Predictable Results and Experience in Diabetes Through Intensification and Control to Target: an International Variability Evaluation) is a multi-national study designed to evaluate the safety and efficacy of insulin detemir (Levemir®) in "real world" medical practice. The aim of the study is to report the PREDICTIVE results of the Belgian type 1 diabetic cohort.Methods – Two hundred and thirty-two patients treated with a basal-bolus insulin scheme were considered for analysis. Seventy-eight percent of those patients were previously treated with insulin glargine as a basal insulin, while 22 % received NPH, before switching to Levemir®.Results - Mean age and duration of diabetes were 45±15 and 18±13 years, respectively (means±SD). HbA1C was 8.3±1.2 %. We observed (at weeks 12 and 26 after baseline) a significant reduction in all hypoglycaemic events including major hypoglycaemias after switching to detemir (p<0.0001). There was no change in HbA1C. Fasting blood glucose decreased from 170±49 to 158±45 mg/dl at week 26 (p<0.009), while fasting blood glucose variability was reduced from 69±35 to 57±30 mg/dl at week 26 (p<0.0001). Total insulin doses increased during the trial from 0.74±0.28 to 0.82±0.14 U/kg/day (p<0.0001). No weight gain was observed during the study. Patient’s satisfaction increased significantly (from 6.3±1.5 to 7.2±1.6 at week 26, p<0.0001).Conclusion - This report from the Belgian cohort of PREDICTIVE extends the safety and efficacy data of insulin detemir in type 1 diabetic patients treated with a basal-bolus insulin scheme.