PMID- 38320260
OWN - NLM
STAT- MEDLINE
DCOM- 20240422
LR  - 20240427
IS  - 1939-327X (Electronic)
IS  - 0012-1797 (Print)
IS  - 0012-1797 (Linking)
VI  - 73
IP  - 5
DP  - 2024 May 1
TI  - Acetyllevocarnitine Hydrochloride for the Treatment of Diabetic Peripheral 
      Neuropathy: A Phase 3 Randomized Clinical Trial in China.
PG  - 797-805
LID - 10.2337/db23-0377 [doi]
AB  - Diabetic peripheral neuropathy (DPN) is a highly prevalent chronic complication 
      in type 2 diabetes (T2D) for which no effective treatment is available. In this 
      multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial 
      in China, patients with T2D with DPN received acetyllevocarnitine hydrochloride 
      (ALC; 1,500 mg/day; n = 231) or placebo (n = 227) for 24 weeks, during which 
      antidiabetic therapy was maintained. A significantly greater reduction in 
      modified Toronto clinical neuropathy score (mTCNS) as the primary end point 
      occurred in the ALC group (-6.9 +/- 5.3 points) compared with 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 with 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.
CI  - (c) 2024 by the American Diabetes Association.
FAU - Guo, Lixin
AU  - Guo L
AUID- ORCID: 0009-0000-5947-8293
AD  - Department of Endocrinology, Beijing Hospital, National Center of Gerontology, 
      Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 
      China.
FAU - Pan, Qi
AU  - Pan Q
AD  - Department of Endocrinology, Beijing Hospital, National Center of Gerontology, 
      Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 
      China.
FAU - Cheng, Zhifeng
AU  - Cheng Z
AD  - Department of Endocrinology, Fourth Hospital of Harbin Medical University, 
      Harbin, China.
FAU - Li, Zhiyong
AU  - Li Z
AD  - Department of Endocrinology, Yongchuan Hospital of Chongqing Medical University, 
      Chongqing, China.
FAU - Jiang, Hongwei
AU  - Jiang H
AD  - Department of Endocrinology, First Affiliated Hospital of Henan University of 
      Science and Technology, Luoyang, China.
FAU - Zhang, Fang
AU  - Zhang F
AD  - Department of Endocrinology, Kaifeng Hospital of Traditional Chinese Medicine, 
      Kaifeng, China.
FAU - Li, Yufeng
AU  - Li Y
AD  - Department of Endocrinology, Beijing Pinggu Hospital, Beijing, China.
FAU - Qiu, Wei
AU  - Qiu W
AD  - Department of Endocrinology, Xinxiang First People's Hospital, Affiliated 
      People's Hospital of Xinxiang Medical University, Xinxiang, China.
FAU - Lu, Song
AU  - Lu S
AD  - Department of Endocrinology, Chongqing General Hospital, Chongqing, China.
FAU - Tian, Junhang
AU  - Tian J
AD  - Department of Endocrinology, Luoyang Third People's Hospital, Luoyang, China.
FAU - Fu, Yanqin
AU  - Fu Y
AD  - Department of Endocrinology, Second Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, China.
FAU - Li, Fangqiong
AU  - Li F
AD  - Haisco Pharmaceutical Group Co., Ltd., Chengdu, China.
FAU - Li, Danqing
AU  - Li D
AD  - Haisco Pharmaceutical Group Co., Ltd., Chengdu, China.
LA  - eng
GR  - Haisco Pharmaceutical Group Co., Ltd./
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Diabetes
JT  - Diabetes
JID - 0372763
SB  - IM
MH  - Humans
MH  - *Diabetic Neuropathies/drug therapy
MH  - *Diabetes Mellitus, Type 2/complications/drug therapy
MH  - Pain
MH  - Treatment Outcome
MH  - China
MH  - Double-Blind Method
PMC - PMC11043058
COIS- Duality of Interest. This trial was supported by Haisco Pharmaceutical Group Co., 
      Ltd. F.L. and D.L. are employees of Haisco Pharmaceutical Group Co., Ltd. No 
      other potential conflicts of interest relevant to this article were reported.
EDAT- 2024/02/06 18:42
MHDA- 2024/04/22 06:43
PMCR- 2024/02/06
CRDT- 2024/02/06 16:43
PHST- 2023/05/15 00:00 [received]
PHST- 2024/02/01 00:00 [accepted]
PHST- 2024/04/22 06:43 [medline]
PHST- 2024/02/06 18:42 [pubmed]
PHST- 2024/02/06 16:43 [entrez]
PHST- 2024/02/06 00:00 [pmc-release]
AID - 154206 [pii]
AID - 230377 [pii]
AID - 10.2337/db23-0377 [doi]
PST - ppublish
SO  - Diabetes. 2024 May 1;73(5):797-805. doi: 10.2337/db23-0377.