A Randomized Controlled Trial of R-Form Verapamil Added to Ongoing Metformin Therapy in Patients with Type 2 Diabetes

Chih Yuan Wang, Kuo Chin Huang, Chia Wen Lu, Chih Hsun Chu, Chien Ning Huang, Harn Shen Chen, I. Te Lee, Jung Fu Chen, Ching Chu Chen, Chung Sen Chen, Chang Hsun Hsieh, Kai Jen Tien, Hung Yu Chien, Yu Yao Huang, Jui Pao Hsu, Guang Tzuu Shane, Ai Ching Chang, Yen Chieh Wu, Wayne Huey Herng Sheu

研究成果: Article同行評審

3 引文 斯高帕斯(Scopus)


CONTEXT: There is a medical need for effective insulin-independent antidiabetic drugs that can promote pancreatic β-cell function and have a low risk of hypoglycemia in type 2 diabetes mellitus (T2DM) patients. R-form verapamil (R-Vera), which is able to enhance the survival of β-cells and has higher cardiovascular safety margin compared with racemic verapamil, was developed as a novel approach for T2DM treatment. OBJECTIVE: This randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of 3 dosages of R-Vera added to ongoing metformin therapy in T2DM patients who had inadequate glycemic control on metformin alone. METHODS: Participants were randomly assigned in an equal ratio to receive R-Vera 450, 300, or 150 mg per day, or matching placebo, in combination with metformin. The primary endpoint was change in hemoglobin A1c (HbA1c) after 12 weeks of treatment. RESULTS: A total of 184 eligible participants were randomized to receive either R-Vera or placebo plus metformin. At week 12, significant reductions in HbA1c were observed for R-Vera 300 mg/day (-0.36, P = 0.0373) and 450 mg/day (-0.45, P = 0.0098) compared with placebo. The reduction in HbA1c correlated with decreasing fasting plasma glucose levels and improved HOMA2-β score. Treatment with R-Vera was well tolerated with no hypoglycemic episodes occurring during the trial. CONCLUSION: Addition of R-Vera twice daily to ongoing metformin therapy significantly improved glycemic control in T2DM patients. The favorable efficacy and safety profile of R-Vera 300 mg/day can be considered as the appropriate dose for clinical practice.

頁(從 - 到)e4063-e4071
期刊Journal of Clinical Endocrinology and Metabolism
出版狀態Published - 28 9月 2022


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