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21. Basal insulin peglispro versus insulin glargine in insulin-naïve type 2 diabetes: IMAGINE 2 randomized trial.

Author

Davies, M. J., Russell‐Jones, D., Selam, J.‐L., Bailey, T. S., Kerényi, Z., Luo, J., Bue‐Valleskey, J., Iványi, T., Hartman, M. L., Jacobson, J. G., and Jacober, S. J.

Subjects
INSULIN therapy, TYPE 2 diabetes treatment, GLYCOSYLATED hemoglobin, RANDOMIZED controlled trials, TRIGLYCERIDES, PEOPLE with diabetes
Abstract

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. [ABSTRACT FROM AUTHOR]

Published
2016
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