Efficacy and safety of LY2963016 insulin glargine versus insulin glargine (Lantus) in Chinese adults with type 2 diabetes: A phase III, randomized, open-label, controlled trial.

ABSTRACT:

Aim

To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) with insulin glargine (Lantus; IGlar) combined with oral antihyperglycaemic medications (OAMs) in insulin-naive Chinese patients with type 2 diabetes (T2D).

Materials and methods

In this phase III, open-label trial, adult patients with T2D receiving two or more OAMs at stable doses for 12 weeks or longer, with HbA1c of 7.0% or more and 11.0% or less, were randomized (2:1) to receive once-daily LY IGlar or IGlar for 24 weeks. The primary outcome was non-inferiority of LY IGlar to IGlar at a 0.4% margin, and a gated secondary endpoint tested non-inferiority of IGlar to LY IGlar (-0.4% margin), assessed by least squares (LS) mean change in HbA1c from baseline to 24 weeks.

Results

Patients ass

SUBMITTER: Feng W 

PROVIDER: S-EPMC8361736 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature