Aim: The AT.LANTUS study compared insulin glargine initiation and titration using one of two algorithms in suboptimally controlled subjects with type 2 diabetes mellitus (T2DM) based on a primary outcome of severe hypoglycaemia. Secondary outcomes included other categories of hypoglycaemia, glycaemic control, weight changes and insulin dose. Here, we report the results of a subanalysis of the trial, which investigated whether insulin glargine can be initiated and titrated as effectively in primary [general practitioner (GP)] as secondary (hospital) care in patients with T2DM in the UK.
Methods: The main study was a multicentre (n = 611), multinational (n = 59), open-label, 24-week randomized trial in 4,588 suboptimally controlled subjects with T2DM. Insulin glargine was titrated to target fasting blood glucose (FBG) levels of <or=5.5 mmol/l according to algorithm 1 (clinic-driven titration) or algorithm 2 (patient-managed titration). In this substudy, 819 subjects (GP, n = 215; hospital, n = 604) from 57 primary and 130 secondary care centres were included in the subanalysis; subjects were switched to once-daily insulin glargine from baseline treatments that consisted primarily of oral antidiabetic agents (OADs) (38%) only or premixed insulin +/- OAD (23%).
Results: Both the GP and the hospital groups of subjects experienced a low incidence of severe hypoglycaemia (<1%), with significant decreases in HbA1c levels (-0.51 and -0.95% respectively; p < 0.001), large reductions in FBG levels (-2.72 and 3.0 mmol/l respectively; p < 0.001) and modest weight gain of 1 and 1.2 kg respectively (p < 0.05). With the exception of absolute reductions in HbA1c and reductions in basal and prandial insulin made on switching to insulin glargine, there were few significant differences in subjects managed in primary compared with secondary care.
Conclusions: This study shows that despite differences in diabetes duration and baseline glycaemic control, an insulin glargine-based therapy can be safely and effectively initiated in a diverse range of suboptimally controlled subjects with T2DM in both primary and secondary care settings in the UK. Rates of hypoglycaemia were low and consistent with the results of the main study. Absolute reductions in HbA1c were greatest in the secondary care setting, but similar levels of glycaemic control were achieved in both groups due to differences in baseline HbA1c. In the patients managed in primary care, there was an overall reduction in prandial and basal insulin used when switching to a basal insulin regimen and a lack of titration of prandial insulin. Therefore, the role of prandial insulin, its initiation and titration, appears to be an area that requires more focus in primary care.