The AT.
LANTUS trial recently demonstrated the efficacy and safety of
insulin glargine initiation and maintenance using two different treatment algorithms in poorly controlled
type 2 diabetes mellitus (T2DM). This sub-analysis investigated
glycemic control and safety in 686 patients switching from premixed
insulin (premix) with or without (+/-OADs) to once-daily
glargine (+/-OADs/prandial
insulin). A 24-week, multinational (n=59), multicenter (n=611), randomized study comparing two algorithms (Algorithm 1: clinic-driven titration; Algorithm 2: patient-driven titration) in four
glargine+/-OADs treatment groups: alone, once- (OD), twice- (BD) or >twice- (>BD) daily prandial
insulin. After switching to the
glargine regimen, HbA(1c) levels significantly improved in the overall group (9.0+/-1.3 to 8.0+/-1.2%; p<0.001) and in all subgroups; fasting
blood glucose levels also improved in all subgroups (overall: 167.1+/-50.0 to 106.9+/-27.2 mg/dL [9.3+/-2.8 to 5.9+/-1.5 mmol/L]; p<0.001). The incidence of severe
hypoglycemia was also low in all four subgroups (< or =1.7%). Patients with T2DM switching from premix+/-OADs to
glargine+/-OADs had significant reductions in
glycemic control with a low incidence of severe
hypoglycemia. The addition of prandial (OD, BD or >BD)
insulin was associated with further improvements in
glycemic control. These data provide support for the stepwise introduction of prandial
insulin to a more physiologic basal-bolus regimen, which is under investigation.