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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
Author(s) -
Arakaki R. F.,
Blevins T. C.,
Wise J. K.,
Liljenquist D. R.,
Jiang H. H.,
Jacobson J. G.,
Martin S. A.,
Jackson J. A.
Publication year - 2014
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12242
Subject(s) - insulin glargine , medicine , exenatide , type 2 diabetes , diabetes mellitus , urology , insulin lispro , endocrinology , gastroenterology
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 .