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Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine
Author(s) -
Hadjiyianni I.,
Dahl D.,
Lacaya L. B.,
Pollom R. K.,
Chang C. L.,
Ilag L. L.
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.12628
Subject(s) - insulin glargine , medicine , type 2 diabetes , randomization , adverse effect , diabetes mellitus , clinical endpoint , randomized controlled trial , endocrinology
The safety and efficacy of LY2963016 insulin glargine ( LY IGlar ) and Lantus ® insulin glargine ( IGlar ), products with identical primary amino acid sequences, were assessed in subgroups of patients with type 1 ( T1D , n = 452) or type 2 diabetes ( T2D , n = 299) reporting prestudy IGlar treatment in 52‐week open‐label ( ELEMENT ‐1) and 24‐week double‐blind ( ELEMENT ‐2) studies. At randomization, patients transitioned from their prestudy IGlar to equivalent doses of LY IGlar or IGlar . Primary efficacy (change in glycated haemoglobin from baseline to 24 weeks), other efficacy and select safety outcomes of LY IGlar were compared with those of IGlar . Continuous data were analysed using analysis of covariance, categorical data by Fisher's exact test, and treatment comparisons for hypoglycaemia by Wilcoxon test. No statistically significant treatment differences were identified for efficacy and safety outcomes except for weight change ( T1D ), overall incidence of detectable insulin antibodies ( T2D ), and serious adverse events ( T2D ). These differences were neither consistently observed across both studies nor observed in the total study populations, and their magnitude suggests they were not clinically meaningful. LY IGlar and IGlar show similar efficacy and safety profiles in patients reporting prestudy IGlar treatment.