A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period

Summary

This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.

Timeline

Start

2021-05-20

Primary completion

2023-02-24

Completion

2023-02-24

Publications

• Chen L, Wen B, Liu H, Wu H, Duan B, Shu H, Zhang Q, Wu X, Li M, Han Y, Kang L, Zhang M. Efficacy and safety of insulin glargine 300 U/mL in people with type 2 diabetes in China: The INITIATION study. Diabetes Obes Metab. 2024 Oct;26(10):4571-4582. doi: 10.1111/dom.15814. Epub 2024 Jul 29.

Drugs

Indications