Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: Clinical practice experience from a German subgroup of the PREDICTIVE study

Aim: The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation (PREDICTIVE) Study is a large, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice. Methods: This subgroup analysis of the German cohortof PREDICTIVE evaluates over 3 months, patients with type 2 diabetes who were transferred to insulin detemir ± oral antidiabetic drugs (OADs) from an OAD-only regimen (n = 1321), NPH insulin ± OADs (n = 251) or insulin glargine ± OADs (n = 260). Results: Among all groups, 3 months after starting treatment with insulin detemir, total, daytime and nocturnal hypoglycaemic events/patient were reduced by 84, 80 and 90%, respectively, from baseline. No major hypoglycaemic events were reported during treatment with insulin detemir. HbAlc was significantly reduced from baseline in each of the subgroups (-1.29,-0.60 and-0.59% for patients previously taking OADs only, NPH insulin ± OADs and insulin glargine ± OADs respectively; p < 0.0001), as was fasting blood glucose (FBG) (-58.1, -29.1 and-24.6 mg/dl; p < 0.0001) and FBG variability-8.2 mg/dl, -5.7 mg/dl; p < 0.0001 and -5.1 mg/dl; p = 0.0008). All subgroups combined lost an average of 0.9 kg of body weight (p < 0.0001) during the study. Total daily basal insulin dose increased slightly from baseline for those patients on a prior insulin regimen, and in this study 79% of patients used insulin detemir once daily. Conclusions: These data confirm the short-term safety and efficacy of insulin detemir ± OADs in a real-world scenario and support the findings of randomized controlled clinical trials with insulin detemir, including its limited effects on body weight.