Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: Subgroup analysis from the PREDICTIVE™ study

Objective: Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation (PREDICTIVE™) is a multi-national, open-label, prospective, observational study assessing the safety and efficacy of insulin detemir in clinical practice. This post hoc subanalysis evaluates insulin-naïve patients on oral antidiabetic drugs (OADs) who were initiated on insulin detemir as basal therapy (± OADs). Methods: The European cohort of the PREDICTIVE study currently includes 20,531 patients (12,981 with type 2 diabetes) who were prescribed insulin detemir and followed up for 12, 26 or 52 weeks. Here, we report data from a subgroup of 2377 OAD-treated, insulin-naïve type 2 diabetes patients for a mean follow-up of 14.4 weeks. Patients were prescribed insulin detemir as basal therapy (± OADs) by their physician, as part of routine clinical care. Results were reported in comparison with baseline observations. Results: One serious adverse drug reaction was reported, which was a major hypoglycaemic episode. Treatment with insulin detemir (± OADs) significantly reduced mean haemoglobin A_1c (HbA_1c) (-1.3%; p < 0.0001), fasting glucose (-3.7 mmol/l; p < 0.0001), and within-patient fasting glucose variability (-0.5 mmol/l; p < 0.0001). In the majority of patients (82%), these improvements in glycaemic control were achieved with once daily administration of insulin detemir. There was a small reduction in mean body weight (-0.7 kg; p < 0.0001), which was most apparent in patients with a higher body mass index (BMI) at baseline. A significant negative relationship between weight change and baseline BMI was observed (greater the BMI, greater the weight reduction). Multiple regression analysis showed that BMI and HbA _1c at baseline, and change in HbA_1c, were all predictors for weight change (p < 0.0001 for all), with BMI being the strongest predictor. Conclusions: Patients with type 2 diabetes naïve to insulin can be effectively treated with once-daily insulin detemir (± OADs) to achieve improved glycaemic control with no adverse effect on weight and a low risk of hypoglycaemia. These short-term results are consistent with the findings of clinical trials.