Lilly Insulin Glargine Versus Lantus^® in Insulin-Naive and Insulin-Treated Adults with Type 2 Diabetes: A Randomized, Controlled Trial (ELEMENT 5).

ABSTRACT:

Introduction

This study compared the efficacy and safety of similar U-100 insulin glargine products, namely, Lilly insulin glargine (LY IGlar; Basaglar^®) and the reference insulin glargine product (IGlar; Lantus^®), used once daily in combination with oral antihyperglycemic medications (OAMs) in adults with type 2 diabetes (T2D).

Methods

ELEMENT 5 was a phase III, randomized, multinational, open-label, treat-to-target, 24-week trial. Participants were insulin naïve (glycated hemoglobin [HbA1c] ≥ 7.0% to ≤ 11.0%) or on basal insulin (IGlar, neutral protamine Hagedorn or insulin detemir; HbA1c ≤ 11.0%) and taking ≥ 2 OAMs. The primary objective was to show  that LY IGlar is noninferior to IGlar in terms of HbA1c reduction (0.4% noninferiority margin).

R

SUBMITTER: Pollom RK 

PROVIDER: S-EPMC6349279 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature