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

Abstract

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.

• Authors: Priscilla A Hollander, Wendy L Carofano, Raymond L H Lam, Gregory T Golm, Roy Eldor, Michael F Crutchlow, Michael C Marcos, Marc S Rendell, Philip D Home, Baptist Gallwitz, Julio Rosenstock
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 20 Issue 9 Pg. 2229-2237 (09 2018) ISSN: 1463-1326 [Electronic] England
• PMID: 29761615 (Publication Type: Clinical Trial, Phase III, Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 John Wiley & Sons Ltd.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin Antibodies
• hemoglobin A1c protein, human
• Insulin Glargine

Topics

• Aged
• Algorithms
• Blood Glucose (analysis)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Female
• Glycated Hemoglobin (drug effects)
• Humans
• Hypoglycemia (chemically induced)
• Hypoglycemic Agents (administration & dosage)
• Insulin Antibodies (blood, immunology)
• Insulin Glargine (administration & dosage)
• Least-Squares Analysis
• Male
• Middle Aged
• Treatment Outcome