| Autor: |
Xiaoling Cai, Linong Ji, Mingxia Yuan, Jianhua Ma, Fang Bian, Sheli Li, Wuyan Pang, Shuang Yan, Huimin Zhou, Minghui Hou, Wenhui Li, Ying Jia, Li Liu, Ke Ding, Michael Xu |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
The Lancet Regional Health. Western Pacific, Vol 51, Iss , Pp 101197- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2666-6065 |
| DOI: |
10.1016/j.lanwpc.2024.101197 |
| Popis: |
Summary: Background: Visepegenatide, a once-weekly glucagon-like peptide-1 receptor agonist injection, demonstrated effective glycaemic control and good tolerability without the requirement of dose titration in the two completed phase 2 studies. We aimed to evaluate the efficacy and safety of visepegenatide in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin monotherapy in this phase 3 clinical study. Methods: This multicentre phase 3 clinical study included a 24-week, randomised, placebo-controlled, double-blind period followed by a 28-week open-label extended treatment period. Patients (N = 620) aged ≥18 and ≤75 years with glycated haemoglobin (HbA1c) ≥7.0% and ≤10.5% [≥53.0 and ≤91.27 mmol/mol], were randomized in a 1:1 ratio to receive visepegenatide 150-μg or placebo once-weekly subcutaneous injection during the double-blind period. Subsequently, the patients in the placebo group were switched to visepegenatide treatment (placebo→visepegenatide group), and the patients in the visepegenatide group continued the same treatment during the open-label extended treatment period. The primary endpoint was the change in HbA1c from baseline to week 24. Findings: At week 24, the placebo-adjusted least squares mean (LSM) change of HbA1c was −0.57% (95% CI −0.71 to −0.43) with visepegenatide (p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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