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 < 0.0007). 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 < 0.0007). 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.
