Observational, open-label study of type 1 and type 2 diabetes patients switching from human insulin to insulin analogue basal–bolus regimens: insights from the PREDICTIVE study

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 wa...