Premium
Efficacy and safety of MK‐1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open‐label clinical trial
Author(s) -
Home Philip D.,
Lam Raymond L. H.,
Carofano Wendy L.,
Golm Gregory T.,
Eldor Roy,
Crutchlow Michael F.,
Marcos Michael C.,
Rosenstock Julio,
Hollander Priscilla A.,
Gallwitz Baptist
Publication year - 2018
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.13354
Subject(s) - insulin glargine , medicine , insulin , diabetes mellitus , endocrinology , type 2 diabetes , type 1 diabetes , basal (medicine) , gastroenterology
Aim To compare the efficacy and safety of MK‐1293 insulin glargine (Mk‐Gla; 100 U/mL) with originator insulin glargine, Lantus (Sa‐Gla), in people with type 1 diabetes mellitus (T1DM). Materials and methods This phase 3, randomized, active‐controlled, open‐label, 52‐week study ( ClinicalTrials.gov NCT02059161) enrolled 508 people with T1DM (HbA1c ≤11.0%; 97 mmol/mol) taking basal and prandial insulin. Participants were randomized 1:1 to once‐daily Mk‐Gla (n = 245) or Sa‐Gla (n = 263). Dose titration of basal insulin was by a pre‐breakfast plasma glucose dosing algorithm. The primary efficacy objective was assessment of the non‐inferiority of HbA1c change from baseline (margin of 0.40% [4.4 mmol/mol]) for Mk‐Gla compared with Sa‐Gla over 24 weeks. The primary safety objective was assessment of anti‐insulin antibody development over 24 weeks. Results The least squares (LS) mean HbA1c change from baseline at week 24 was −0.62 (95% CI −0.79, −0.45)% (−6.8 [−8.7, −4.9] mmol/mol) and −0.66 (−0.82, −0.50)% (−7.2 [−9.0, −5.4] mmol/mol) for Mk‐Gla and Sa‐Gla. The LS mean HbA1c difference was 0.04 (−0.11, 0.19)% (0.4 [−1.2, 2.0] mmol/mol) for Mk‐Gla minus Sa‐Gla, meeting the primary and secondary objective criteria for non‐inferiority and equivalence. Week 24 mean insulin glargine dose for Mk‐Gla and Sa‐Gla was 0.46 and 0.48 U/kg, respectively. Similarity of HbA1c response and basal insulin dose trajectory persisted over the 52 weeks. Safety and tolerability, including anti‐insulin antibody responses, hypoglycaemia, adverse events and body weight, were similar between insulins over the 52‐week study duration. Conclusions Mk‐Gla and Sa‐Gla exhibited similar efficacy and safety over 52 weeks in people with T1DM. ClinicalTrials.gov : NCT02059161