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Aims  To compare efficacy and safety of two, once‐daily basal insulin formulations [insulin lispro protamine suspension ( ILPS ) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications ( OAMs ) and exenatide  BID  in suboptimally controlled type 2 diabetes ( T2D ) patients.    Methods  This 24‐week, open‐label, multicentre trial randomized patients to bedtime  ILPS  (n = 171) or glargine (n = 168). Non‐inferiority of  ILPS  versus glargine was assessed by comparing the upper limit of 95% confidence intervals ( CIs ) for change in haemoglobin A1c ( HbA1c ) from baseline to week 24 (adjusted for baseline  HbA1c ) with non‐inferiority margin 0.4%.    Results  Non‐inferiority of  ILPS  versus glargine was demonstrated: least‐squares mean between‐treatment difference ( ILPS  minus glargine) (95%  CI ) was 0.22% (0.06, 0.38). Mean  HbA1c  reduction was less for  ILPS ‐ versus glargine‐treated patients (−1.16 ± 0.84 vs. −1.40 ± 0.97%, p = 0.008). Endpoint  HbA1c  < 7.0% was achieved by 53.7% ( ILPS ) and 61.7% (glargine) (p =  NS ). Overall hypoglycaemia rates (p =  NS ) and severe hypoglycaemia incidence (p =  NS ) were similar. Nocturnal hypoglycaemia rate was higher in patients treated with  ILPS  versus glargine (p = 0.004). Weight gain was similar between groups ( ILPS : 0.27 ± 3.38 kg; glargine: 0.66 ± 3.93 kg, p =  NS ). Endpoint total insulin doses were lower in patients treated with  ILPS  versus glargine (0.30 ± 0.17 vs. 0.37 ± 0.17  IU /kg/day, p < 0.001).    Conclusions   ILPS  was non‐inferior to glargine for  HbA1c  change over 24 weeks, but was associated with less  HbA1c  reduction and more nocturnal hypoglycaemia. Treat‐to‐target basal insulin therapy improves glycaemic control and is associated with minimal weight gain when added to  OAMs  and exenatide  BID  for suboptimally controlled  T2D .

diabetes, obesity and metabolism

Comparison of insulin lispro protamine suspension versus insulin glargine once daily added to oral antihyperglycaemic medications and exenatide in type 2 diabetes: a prospective randomized open‐label trial