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AbstractObjective:Evaluation of the safety and efficacy of insulin detemir (IDet) in the observational and non-interventional PREDICTIVE study.Methods:A total of 2923 patients with type 1 or 2 diabetes on basal–bolus regimens were followed for 6 months: Group (1) NPH  human insulin (HI) bolus switching to IDet  analogue bolus (n  349); Group (2) NPH  HI bolus switching to IDet  HI bolus (n  500); Group (3) NPH  analogue bolus switching to IDet  analogue bolus (n  1144); Group (4) Glargine  analogue bolus switching to IDet  analogue bolus (n  704). Primary endpoint was major hypoglycaemia; change in HbA1c, fasting plasma glucose, fasting plasma glucose variability and bodyweight were secondary endpoints.Results:These results need critical review due to the observational nature of the study (non-randomisation, no control group) as well as limitations of a possible study effect and the fact that some endpoints are based on patient recall, diaries or reports. Mean incidence of any hypoglycaemia was significantly reduced following the switch to insulin detemir therapy in all groups: the greatest reduction in total hypoglycaemia was in Group 1 from 42.38 to 20.28 episodes per patient-year (mean difference −22.10; p < 0.0001) and in nocturnal hypoglycaemia from 11.83 to 2.08 episodes/patient-year (mean difference −9.88; p < 0.0001). HbA1c, FPG and FPG variability also improved significantly in all groups: the greatest reduction in HbA1cwas in Group 1 from 8.13 to 7.42 (mean difference −0.71; p < 0.0001). Bodyweight was reduced in all groups.Conclusions:Whichever basal–bolus insulins were previously used, switching to insulin detemir as the basal insulin component resulted in significant lowering of hypoglycaemia, HbA1c, FPG and bodyweight over a period of 6 months in patients with type 1 or 2 diabetes. Switching to an all-analogue regimen may be the most effective option when moving patients from human insulin-based basal–bolus regimens. [ABSTRACT FROM AUTHOR]

Objective: PREDICTIVE is a multi-national, prospective, observational study, assessing the safety and efficacy of insulin detemir in patients with diabetes.Research design and methods: The European cohort includes 20 531 patients with diabetes (7420 type 1) from 11 countries. A subgroup of 4782 type 1 patients were transferred from a basal-bolus regimen with NPH insulin (n = 3117) or insulin glargine (n = 1665) to insulin detemir basal-bolus therapy; or from a human insulin basal-bolus regimen (n = 570) to insulin detemir/insulin aspart (part of the pre-study NPH group). Mean follow-up was 14.4 weeks. The primary endpoint was serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary endpoints were: incidence of overall and nocturnal hypoglycaemia; haemoglobin A1c (HbA1c); fasting glucose; within-patient fasting glucose variability; and change in body weight.Results: SADRs were reported by 62 (2.0%) patients previously receiving NPH insulin, 45 (2.7%) patients previously receiving insulin glargine and seven (1.2%) patients previously receiving human basal-bolus insulins. Major hypoglycaemia was significantly reduced in NPH insulin (55%), insulin glargine (51%), and human basal-bolus insulin groups (54%; p < 0.0001 for all). Total and nocturnal hypoglycaemic episodes were also significantly reduced in all groups (p < 0.0001 for all). HbA1c was reduced in patients previously receiving NPH insulin (0.5%), insulin glargine (0.4%), and human basal-bolus insulins (0.6%; p < 0.0001 for all). Mean fasting glucose and within-patient fasting glucose variability significantly decreased in all patients (p < 0.0001 for all). Body weight remained stable.Conclusions: In this open-label, prospective, observational study, insulin detemir basal-bolus therapy improved glycaemic control and reduced hypoglycaemia with weight neutrality in type 1 patients in actual clinical practice. [ABSTRACT FROM AUTHOR]