Jinlida for Diabetes Prevention in Impaired Glucose Tolerance and Multiple Metabolic Abnormalities
Authors: Ji Hangyu , Zhao Xuefei , Chen Xinyan , Fang Hui , Gao Huailin , Wei Geng , Zhang Min , Kuang Hongyu , Yang Baijing , Cai Xiaojun , Su Yanjin , Piao Chunli , Zhao Shuyu , Li Liyang , Sun Wenliang , Xu Tianshu , Xu Qinghua , Fan Yuan , Ye Jianhua , Yao Chen , Shang Meixia , Song Guangyao , Chen Liming , Zheng Qingshan , Xiao Xinhua , Yan Li , Lian Fengmei , Tong Xiaolin , Jia Zhenhua ,   FOCUS Trial Committees and Investigators, Lun Liying , Hu Sulin , Liu Haipeng , Cai Guangyu , Li Huan , Huang Ling , Tian Mengling , Wan Jiale , Song Peizhen , Zhang Yaqin , Li Fan , Hu Xiaoyan , Xu Jing , Pang Ying , Shi Jing , Cheng Hongwei , Tian Wenhong , Wang Huiling , Qin Gangxin , Zhao Qiuju , Wang Lulu , Luo Junting , Liu Luyv , Zhao Li , Xie Wenjiao , Cai Xinlun , Qiao Gaohong , Song Aoran , Li Jianxiu , Zhang Wendan , Wu Qiong , Wang Yanan , Fang Qijun , Yue Lijun , Zhang Yuling , Hu Li , You Qin , Wang Li , Zhao Siyu , Zhang Liwei , Guo Hui , Dai Lina , Niu Wenjuan , Gao Wei , Li Minzhou , Zhang Ruixia , Liu Yixuan , Wang Jingwen , Zhang Congchao , Li Siyuan , Feng Yurong , Dai Yingran , Sa Ren , Sang Lili , Wang Haiyan , Yin Weiwei , Zhang Hong , Sun Fengjun , Ma Li , Yang Junyong , Zhang Xuanmin , Gan Xia , Sheng Yang , Zhou Yun , Lu Junhu , Xu Tong , Li Haoran , Li Zhen , Pan Xiaoxia , Zhang Li , Han Jialin , Yu Acui , Jing Jingqing , Huang Li , Chen Xi , Wang Xuling , Shi Jilai , Wang Bingyan , Sun Guanghui , Li Kaimin , Zhou Tingting , Shi Mengying , Liu Hongli , Sun Xueling , Zhang Hewei , Hong Wenhui , Huang Nan , Chen Xiufen , Zheng Jinxiang , Juan Yongjuan , Zhou Rongrong , Wang Huidan , Zang Chunxue , Lai Yiwen , Peng Zedong , Chen Ruyu , Liu Xinhui , Cai Mengjie , Han Xu 
Published: June 2024

Importance

Previous studies have shown that Jinlida (JLD) granules, an approved treatment for type 2 diabetes in China, can reduce blood glucose level, reduce glycated hemoglobin (HbA1c), and improve insulin resistance in people with type 2 diabetes.

Objective

To evaluate the effect of long-term administration of JLD vs placebo on the incidence of diabetes in participants with impaired glucose tolerance (IGT) and multiple metabolic abnormalities.

Design, Setting, and Participants

This multicenter, double-blind, placebo-controlled randomized clinical trial (FOCUS) was conducted across 35 centers in 21 cities in China from June 2019 to February 2023. Individuals aged 18 to 70 years with IGT and multiple metabolic abnormalities were enrolled.

Intervention

Participants were randomly allocated 1:1 to receive JLD or placebo (9 g, 3 times per day, orally). They continued this regimen until they developed diabetes, withdrew from the study, were lost to follow-up, or died.

Main Outcomes and Measures

The primary outcome was the occurrence of diabetes, which was determined by 2 consecutive oral glucose tolerance tests. Secondary outcomes included waist circumference; fasting and 2-hour postprandial plasma glucose levels; HbA1c; fasting insulin level; homeostatic model assessment for insulin resistance (HOMA-IR); total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels; ankle-brachial index; and carotid intima-media thickness.

Results

A total of 889 participants were randomized, of whom 885 were in the full analysis set (442 in the JLD group; 443 in the placebo group; mean [SD] age, 52.57 [10.33] years; 463 [52.32%] female). Following a median observation period of 2.20 years (IQR, 1.27-2.64 years), participants in the JLD group had a lower risk of developing diabetes compared with those in the placebo group (hazard ratio, 0.59; 95% CI, 0.46-0.74; P &amp;lt; .001). During the follow-up period, the JLD group had a between-group difference of 0.95 cm (95% CI, 0.36-1.55 cm) in waist circumference, 9.2 mg/dL (95% CI, 5.4-13.0 mg/dL) in 2-hour postprandial blood glucose level, 3.8 mg/dL (95% CI, 2.2-5.6 mg/dL) in fasting blood glucose level, 0.20% (95% CI, 0.13%-0.27%) in HbA1c, 6.6 mg/dL (95% CI, 1.9-11.2 mg/dL) in total cholesterol level, 4.3 mg/dL (95% CI, 0.8-7.7 mg/dL) in low-density lipoprotein cholesterol level, 25.7 mg/dL (95% CI, 15.9-35.4 mg/dL) in triglyceride levels, and 0.47 (95% CI, 0.12-0.83) in HOMA-IR compared with the placebo group. After 24 months of follow-up, the JLD group had a significant improvement in ankle-brachial index and waist circumference compared with the placebo group.

Conclusions and Relevance

The findings suggest that JLD can reduce the risk of diabetes in participants with IGT and multiple metabolic abnormalities.

Trial Registration

Chinese Clinical Trial Register: ChiCTR1900023241