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Basal insulin peglispro versus insulin glargine in insulin‐naïve type 2 diabetes: IMAGINE 2 randomized trial
Author(s) -
Davies M. J.,
RussellJones D.,
Selam J.L.,
Bailey T. S.,
Kerényi Z.,
Luo J.,
BueValleskey J.,
Iványi T.,
Hartman M. L.,
Jacobson J. G.,
Jacober S. J.
Publication year - 2016
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.12712
Subject(s) - insulin glargine , medicine , gastroenterology , insulin , odds ratio , endocrinology , type 2 diabetes , confidence interval , diabetes mellitus , hypoglycemia , basal (medicine)
Aims To compare, in a double‐blind, randomized, multi‐national study, 52‐ or 78‐week treatment with basal insulin peglispro or insulin glargine, added to pre‐study oral antihyperglycaemic medications, in insulin‐naïve adults with type 2 diabetes. Material and methods The primary outcome was non‐inferiority of peglispro to glargine with regard to glycated haemoglobin ( HbA1c ) reduction (margin = 0.4%). Six gated secondary objectives with statistical multiplicity adjustments focused on other measures of glycaemic control and safety. Liver fat content was measured using MRI , in a subset of patients. Results Peglispro was non‐inferior to glargine in HbA1c reduction [least‐squares ( LS ) mean difference: −0.29%, 95% confidence interval ( CI ) −0.40, −0.19], and had a lower nocturnal hypoglycaemia rate [relative rate 0.74 (95% CI 0.60, 0.91); p = .005), more patients achieving HbA1c <7.0% without nocturnal hypoglycaemia [odds ratio ( OR ) 2.15 (95% CI 1.60, 2.89); p < .001], greater HbA1c reduction (p < .001), and more patients achieving HbA1c <7.0% [ OR 1.97 (95% CI 1.57, 2.47); p < .001]. Total hypoglycaemia rate and fasting serum glucose did not achieve statistical superiority. At 52 weeks, peglispro‐treated patients had higher triglyceride (1.9 vs 1.7 mmol/L). alanine transaminase (34 vs 27 IU / L ), and aspartate transaminase levels (27 vs 24 IU / L ). LS mean liver fat content was unchanged with peglispro at 52 weeks but decreased 3.1% with glargine [difference: 2.6% (0.9, 4.2); p = .002]. More peglispro‐treated patients experienced adverse injection site reactions (3.5% vs 0.6%, p < .001). Conclusions Compared with glargine at 52 weeks, peglispro resulted in a statistically superior reduction in HbA1c , more patients achieving HbA1c targets, less nocturnal hypoglycaemia, no improvement in total hypoglycaemia, higher triglyceride levels, higher aminotransferase levels, and more injection site reactions.