Recently, the internationally renowned pharmacology journal — Frontiers in Pharmacology — published an online clinical study paper on Fulaimei® (PEG-Loxenatide for Injection) from Hansoh Pharma, which evaluated the glucose-lowering effect of Loxenatide using the Continuous Glucose Monitoring (CGM) System for the first time to demonstrate the excellent glucose-lowering effect and good safety of Fulaimei®.
This is a 24-week, randomized, open-label, parallel-controlled clinical study led by the team of Professor Kaijian Hou from The First Affiliated Hospital Longhu of Shantou University Medical College (SUMC). This study aimed to investigate the efficacy and safety of Loxenatide compared to insulin glargine treatment over 24 weeks.
The study showed that in the final two weeks of treatment, the Time in Range (TIR, blood glucose within the target range, 3.9–10.0 mmol/L) for the Loxenatide group and insulin glargine group was 81.4% and 67.9%, respectively (P < 0.001). Compared with insulin glargine, Loxenatide significantly improved the TIR in patients with type 2 diabetes mellitus (T2DM), demonstrating excellent glucose-lowering effect.
The blood glucose fluctuation indicator (SD) was 1.88 mmol/L and 2.22 mmol/L in the Loxenatide and insulin glargine groups, respectively, (P = 0.002), suggesting smaller blood glucose fluctuation in the Loxenatide group and thus more stable glucose-lowering effect. In addition, the TIR of the Loxenatide group was similar to that of the insulin glargine group in the first 2 weeks of treatment. The investigator believes that the onset time of Loxenatide is similar to that of insulin glargine, which can quickly reduce glucose levels in a short period of time.
As the first original GLP-1RA once-weekly formulation developed in China, Fulaimei® adopts third-generation PEGylation technique and features excellent solubility and stability. While significantly reducing blood glucose levels, it leads to only small glucose fluctuation, a rapid onset of action and a low incidence of adverse reactions. It is a suitable once-weekly formulation to start GLP-1 therapy following the failure of oral hypoglycemic agents. At the same time, Fulaimei® helps improve glycemic control in patients with T2DM. Only one injection is needed per week, regardless of meal times, and the injection has a low local reaction, which facilitates patients’ long-term use.
Starting with Fulaimei®, Hansoh Pharma is strengthening its forward-looking layout in endocrinology and investing more in R&D, thereby providing better treatment regimens and drugs for patients with diabetes in China.
About Fulaimei®
Fulaimei® (PEG-Loxenatide for Injection) is the first original GLP-1RA once-weekly formulation developed in China, and the first PEGylated long-acting hypoglycemic drug in the world. It was approved for marketing in May 2019, indicated for type 2 diabetes mellitus. Fulaimei® has been successively included in the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020) and the national medical insurance reimbursement list in China. It has benefited hundreds of thousands of Chinese T2DM patients, providing better treatment options for clinicians and patients.
About Front. Pharmacol.
Frontiers in Pharmacology (Front. Pharmacol., ISSN: 1663-9812, E-ISSN: 1663-9812) is a leading journal in the field of pharmacy and publishes strictly peer-reviewed interdisciplinary research, including basic and clinical pharmacology, medicinal chemistry, pharmacy, and toxicology. This multidisciplinary open-access journal is dedicated to being at the forefront of disseminating and communicating scientific knowledge and influential discoveries to researchers, scholars, clinicians, and the public around the world. The latest Impact Factor of Frontiers in Pharmacology in 2022 is 5.988. Among the 255 SCI-indexed pharmacology journals worldwide, it ranks 47th, in the Q1 quartile.
