Efficacy and safety of insulin degludec/insulin aspart biosimilar B01711 vs originator insulin degludec/insulin aspart in Chinese patients with type 2 diabetes inadequately controlled on basal or premixed insulin: A multicenter, randomized, open-label, phase 3 study.

ABSTRACT:

Aims

To compare the efficacy and safety of insulin degludec/insulin aspart biosimilar B01711 (HS-IDegAsp) with originator insulin degludec/insulin aspart-Ryzodeg (NN-IDegAsp) in Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on once- or twice-daily (BID) premixed or basal insulin ± oral antidiabetic drugs (OADs).

Materials and methods

In this multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study, 367 participants with T2DM were randomized 1:1 to receive BID injections of HS-IDegAsp (n = 183) or NN-IDegAsp (n = 184) for 24 weeks. Insulins were administered subcutaneously with breakfast and the main evening meal at the same titration target. The primary endpoint was the change from baseline in glycated hem

SUBMITTER: Gao L 

PROVIDER: S-EPMC12757660 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature