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Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial

Lookup NU author(s): Emeritus Professor Philip Home

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Abstract

© 2018 John Wiley & Sons Ltd Aim: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM). Materials and methods: This Phase 3, randomized, active-controlled, open-label, 24-week clinical trial (ClinicalTrials.gov number NCT02059187) enrolled 531 participants with T2DM (HbA1c ≤11.0%) either eligible for or currently taking basal insulin (≥10 U/day). Participants were randomized 1:1 to once-daily Mk-Gla (n = 263) or Sa-Gla (n = 263). Titration of insulin was guided by a fasting plasma glucose (FPG)-based dosing algorithm. The primary efficacy objective was to demonstrate the non-inferiority of change from baseline in HbA1c (margin of 0.40% [4.4 mmol/mol]) with Mk-Gla versus Sa-Gla after 24 weeks. The primary safety objective was anti-insulin antibody development after 24 weeks. Results: For Mk-Gla and Sa-Gla, the least squares (LS) mean HbA1c change from baseline (95% CI) was −1.28 (−1.41, −1.15)% (−14.0 [−15.4, −12.6] mmol/mol) and −1.30 (−1.43, −1.18)% (−14.2 [−15.6, −12.8] mmol/mol). The LS mean HbA1c difference (Mk-Gla minus Sa-Gla) was 0.03 (−0.12, 0.18)% (0.3 [−1.4, 1.9] mmol/mol), meeting non-inferiority and equivalence (secondary objective) criteria. Insulin doses, FPG, and seven-point plasma glucose profiles were similar between groups. Safety and tolerability, including anti-insulin antibody responses, hypoglycaemia, adverse events and body weight, were similar between insulins. The efficacy and safety of Mk-Gla and Sa-Gla were similar both in participants who were insulin-treated or insulin-naïve at baseline. Conclusions: Mk-Gla and Sa-Gla demonstrated similar efficacy and safety over 24 weeks of treatment in people with T2DM.

Publication metadata

Author(s): Hollander PA, Carofano WL, Lam RLH, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rendell MS, Home PD, Gallwitz B, Rosenstock J

Publication type: Article

Publication status: Published

Journal: Diabetes, Obesity and Metabolism

Year: 2018

Volume: 20

Issue: 9

Pages: 2229-2237

Print publication date: 01/09/2018

Online publication date: 14/05/2018

Acceptance date: 10/05/2018

ISSN (print): 1462-8902

ISSN (electronic): 1463-1326

Publisher: Wiley-Blackwell

URL: https://doi.org/10.1111/dom.13363

DOI: 10.1111/dom.13363

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