Acetyllevocarnitine hydrochloride for the treatment of diabetic peripheral neuropathy: A phase 3, randomized clinical trial in China,Diabetes

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Acetyllevocarnitine hydrochloride for the treatment of diabetic peripheral neuropathy: A phase 3, randomized clinical trial in China
Diabetes ( IF 7.7 ) Pub Date : 2024-02-06 , DOI: 10.2337/db23-0377
Lixin Guo ₁ , Qi Pan ₁ , Zhifeng Cheng ₂ , Zhiyong Li ₃ , Hongwei Jiang ₄ , Fang Zhang ₅ , Yufeng Li ₆ , Wei Qiu ₇ , Song Lu ₈ , Junhang Tian ₉ , Yanqin Fu ₁₀ , Fangqiong Li ₁₁ , Danqing Li ₁₁

Affiliation

1Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
2Department of Endocrinology, The Fourth Hospital of Harbin Medical University, Harbin 150001, China
3Department of Endocrinology, Yongchuan Hospital of Chongqing Medical University, Chongqing 402160, China
4Department of Endocrinology, First Affiliated Hospital of Henan University of Science and Technology, Luoyang 471000, China
5Department of Endocrinology, Kaifeng Hospital of Traditional Chinese Medicine, Kaifeng 475000, China
6Department of Endocrinology, Beijing Pinggu Hospital, Beijing 101200, China
7Department of Endocrinology, Xinxiang First people’s Hospital, The Affiliated People’s Hospital of Xinxiang Medical University, Xinxiang 453000, China
8Department of Endocrinology, Chongqing General Hospital, Chongqing 400010, China
9Department of Endocrinology, Luoyang Third People’s Hospital, Luoyang 471000, China
10Department of Endocrinology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450003, China
11Haisco Pharmaceutical Group Co., Ltd., Chengdu 611100, China

Diabetic peripheral neuropathy (DPN) is a highly prevalent chronic complication in type-2 diabetes mellitus (T2DM), for which no effective treatment is available. In this multi-center, randomized, double-blind, placebo-controlled phase 3 clinical trial in China, T2DM patients with DPN received acetyllevocarnitine hydrochloride (ALC, 1,500 mg/day, n = 231) or placebo (n = 227) for 24 weeks, during which anti-diabetic therapy was maintained. Significantly greater reduction in modified Toronto Clinical Neuropathy Score (mTCNS) as the primary endpoint occurred in the ALC group (−6.9 ± 5.3 points) compared to the placebo group (−4.7 ± 5.2 points, P < 0.001). Effect sizes (ALC = 1.31 and Placebo = 0.85) represented a 0.65-fold improvement in ALC treatment efficacy. The mTCNS values for pain did not differ significantly between the two groups (P = 0.066), whereas the remaining 10 components of mTCNS showed significant improvement in the ALC group compared to the Placebo group (P < 0.05 for all). Overall results of electrophysiological measurements were inconclusive, with significant improvement in individual measurements limited primarily to the ulnar and median nerves. Incidence of treatment emergent adverse events was 51.2% in the ALC group, among which urinary tract infection (5.9%) and hyperlipidemia (7.9%) were most frequent.

更新日期：2024-02-06

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