Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE study.

Summary Background:  The PREDICTIVE™ study is a multinational observational study designed to follow up patients with diabetes who started insulin detemir (IDet) in routine care. Recruitment started in June 2004 and is ongoing in some countries. Methods:  We report 12-week follow-up data for patients with type 1 (T1D) or type 2 diabetes (T2D) in the European cohort who, as part of basal–bolus therapy, switched from once- (qd) or twice-daily (bid) neutral protamine Hagedorn insulin (NPH) to qd IDet. End-points – evaluated from patients’ records and diaries – were incidence of serious adverse drug reactions, glycaemic parameters, hypoglycaemia and weight change. Results:  A total of 3637 patients were included, n = 1500 T1D [mean age 40.9 years, body mass index (BMI) 25.0 kg/m2, glycosylated haemoglobin (HbA1c) 7.9%] and n = 2137 T2D (mean age 60.5 years, BMI 31.9 kg/m2, HbA1c 8.0%). IDet was well tolerated. Lower overall, major and nocturnal rates of hypoglycaemia were observed in T1D and T2D patients switching from NPH to IDet (overall, T1D: 38.2–18.56 episodes/patient year, p < 0.001; T2D: 13.8–3.2 episodes/patient year, p < 0.001). Switching from bid NPH to qd IDet resulted in significant 12-week reductions in HbA1c (T1D: −0.40%; T2D: −0.56%; both p < 0.001). Switching from qd NPH to qd IDet, resulted in HbA1c reductions of: T1D −0.52%; T2D −0.56%; both p < 0.001. Fasting blood glucose levels were also significantly reduced in patients with T1D or T2D. Overall mean weight changes were: T1D: 0.0 kg, T2D: −0.2 kg after 12 weeks. Conclusion:  In routine care, patients with T1D or T2D may be switched from NPH to IDet qd as part of a basal–bolus regimen.