1.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.
2.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.
3.National Metabolic Management Center(MMC) comprehensive management standards for patients with diabetes, hypertension, and hyperlipidemia
Weiqing WANG ; Yufan WANG ; Guixia WANG ; Aifang WANG ; Chunfang WEN ; Fanrong TIAN ; Guang NING ; Ping FENG ; Dalong ZHU ; Libin LIU ; Bangqun JI ; Heng SU ; Jianling DU ; Shu LI ; Yunsong LI ; Liu YANG ; Li LI ; Shengli WU ; Jinsong KUANG ; Yubo SHA ; Ping ZHANG ; Yawei ZHANG ; Yifei ZHANG ; Qidong ZHENG ; Zhongyan SHAN ; Dong ZHAO ; Zhigang ZHAO ; Tingyu KE ; Yu SHI ; Xuejiang GU ; Ning XU ; Fengmei XU ; Zuhua GAO ; Rong TANG ; Qijuan DONG ; Songbo FU ; Yi SHU ; Weici XIE ; Yuancheng DAI
Chinese Journal of Endocrinology and Metabolism 2024;40(12):1007-1023
Diabetes, hypertension, and dyslipidemia, collectively referred to the " Three Highs, " represent increasingly prevalent metabolic risk factors in China. Many individuals experience all three conditions concurrently, significantly heightening the risk of cardiovascular disease and mortality. Although the National Metabolic Management Center(MMC) has been established for over eight years and has its unique features, the awareness, treatment, and control rates of these diseases in China remain low, and the efficiency of community management is insufficient. According to the previous two editions of management guidelines and the most recent domestic and international diagnostic and treatment guidelines, this paper conducts an in-depth analysis of the operational experience and management strategies of the MMC. Its aim is to improve the efficiency of grassroots MMC mode management for " Three Highs" patients and ensure that patients receive more standardized management.
4.National Metabolic Management Center(MMC) comprehensive management standards for patients with diabetes, hypertension, and hyperlipidemia
Weiqing WANG ; Yufan WANG ; Guixia WANG ; Aifang WANG ; Chunfang WEN ; Fanrong TIAN ; Guang NING ; Ping FENG ; Dalong ZHU ; Libin LIU ; Bangqun JI ; Heng SU ; Jianling DU ; Shu LI ; Yunsong LI ; Liu YANG ; Li LI ; Shengli WU ; Jinsong KUANG ; Yubo SHA ; Ping ZHANG ; Yawei ZHANG ; Yifei ZHANG ; Qidong ZHENG ; Zhongyan SHAN ; Dong ZHAO ; Zhigang ZHAO ; Tingyu KE ; Yu SHI ; Xuejiang GU ; Ning XU ; Fengmei XU ; Zuhua GAO ; Rong TANG ; Qijuan DONG ; Songbo FU ; Yi SHU ; Weici XIE ; Yuancheng DAI
Chinese Journal of Endocrinology and Metabolism 2024;40(12):1007-1023
Diabetes, hypertension, and dyslipidemia, collectively referred to the " Three Highs, " represent increasingly prevalent metabolic risk factors in China. Many individuals experience all three conditions concurrently, significantly heightening the risk of cardiovascular disease and mortality. Although the National Metabolic Management Center(MMC) has been established for over eight years and has its unique features, the awareness, treatment, and control rates of these diseases in China remain low, and the efficiency of community management is insufficient. According to the previous two editions of management guidelines and the most recent domestic and international diagnostic and treatment guidelines, this paper conducts an in-depth analysis of the operational experience and management strategies of the MMC. Its aim is to improve the efficiency of grassroots MMC mode management for " Three Highs" patients and ensure that patients receive more standardized management.
5.Metabolic Disease Management Guideline for National Metabolic Management Center(2nd edition)
Weiqing WANG ; Yufan WANG ; Guixia WANG ; Guang NING ; Dalong ZHU ; Ping LIU ; Libin LIU ; Jianmin LIU ; Zhaoli YAN ; Xulei TANG ; Bangqun JI ; Sunjie YAN ; Heng SU ; Jianling DU ; Sheli LI ; Li LI ; Shengli WU ; Jinsong KUANG ; Yubo SHA ; Ping ZHANG ; Yifei ZHANG ; Lei CHEN ; Zunhai ZHOU ; Chao ZHENG ; Qidong ZHENG ; Zhongyan SHAN ; Dong ZHAO ; Zhigang ZHAO ; Ling HU ; Tingyu KE ; Yu SHI ; Yingfen QIN ; Mingjun GU ; Xuejiang GU ; Fengmei XU ; Zuhua GAO ; Qijuan DONG ; Yi SHU ; Yuancheng DAI
Chinese Journal of Endocrinology and Metabolism 2023;39(6):538-554
The latest epidemiological data suggests that the situation of adult diabetes in China is severe, and metabolic diseases have become significant chronic illnesses that have a serious impact on public health and social development. After more than six years of practice, the National Metabolic Management Center(MMC) has developed distinctive approaches to manage metabolic patients and has achieved a series of positive outcomes, continuously advancing the standardized diagnosis and treatment model. In order to further improve the efficiency, based on the first edition, the second edition guideline was composed by incorporating experience of the past six years in conjunction with the latest international and domestic guidelines.
6.Serum Betatrophin level in patients with polycystic ovary syndrome and its relationship with metabolic parameters
Lu YIN ; Qijuan DONG ; Xiaofei SUN ; Huijie FAN ; Jianghong YU
Chinese Journal of Endocrine Surgery 2022;16(3):325-329
Objective:To investigate the relationship between serum Betatrophin levels and metabolic parameters in patients with polycystic ovary syndrome (PCOS) .Methods:98 patients with PCOS (PCOS group) treated in Zhengzhou People’s Hospital from Dec. 2017 to Sep. 2019 were selected. They were divided into non-obese group ( n=45) and obese group ( n=53) according to BMI value; They were divided into non-IR group ( n= 21) and IR group ( n=77) according to HOMA-IR value; They were divided into non-hyperandrogen group ( n=24) and hyperandrogen group ( n=74) according to TT level; Another 90 healthy women were taken as the control group. The baseline data, lipid metabolism indexes, hormone indexes, glucose metabolism indexes and Betatrophin levels of the two groups were recorded. Pearson test and logisitc regression model were used to analyze the influencing factors related to the increase of serum Betatrophin level in patients with PCOS. Results:Compared with the control group, PCOS group had higher level of BMI, body fat, WHR, VLDL, LDL, TG, TC, FAI, TT, LH, DHEA-S, 17-OHP, FSH, FBG, FINS, and HOMA-IR, while the HDL level was significantly lower. The difference was significant ( P<0.01). Serum Betatrophin level in obese group was significantly higher than that in the control group (163.99±126.97 vs 110.99±102.97), and the difference was statistically significant ( t=3.21, P<0.001) ; serum Betatrophin level in IR group was higher than that in the control group (160.26±136.80 vs 133.17±112.06), and the serum Betatrophin level in IR group was higher than that in the control group (173.51±147.85 vs 144.26±124.56), but the difference was not statistically significant ( P>0.05). Serum Betatrophin levels in PCOS group were positively correlated with BMI, WHR, TG, FAI, FBG, FINS ( P<0.05), and negatively correlated with HDL ( P<0.05). Logistic analysis showed that BMI, WHR and TG were independent factors affecting the increase of serum Betatrophin level. Conclusion:Serum Betatrophin levels of PCOS patients are significantly increased, and BMI, WHR, TG, HDL, FAI, FBG, FINS may play an important role in the occurrence and development of PCOS and obesity, insulin resistance, blood lipids and androgen metabolism disorders.
7.Influence of glucose fluctuation on paraoxonase-3 and apoprotein a in T2DM patients with coronary heart disease
Lu YIN ; Qijuan DONG ; Jianghong YU
Chinese Journal of Diabetes 2018;26(5):380-384
Objective To observe the influence of glucose fluctuation on paraoxonase-3(PON3) and apoprotein A1(ApoA1) in T2DM patients with coronary heart disease (CHD) . Methods A total of 260 subjects were enrolled in this study and dividied into three groups :T2DM patients with CHD (T2DM +CHD group ,n=100) ,T2DM without CHD (T2DM group ,n=80) and healthy subjects(NC group ,n=80) .The serum PON3 and ApoA1 levels were measured and compared in all the three groups .The 72 h dynamic glucose monitoring (CGMS ) was adopted in T2DM + CHD group ,then according to the MAGE levels ,T2DM+ CHD group was subdivided intotertiles :the lowest tertile subgroup (2.43~3.44 mmol/L ,n=31) ,the middle tertile subgroup (3.45~4.46 mmol/L ,n=39) and the highest tertile subgroup (4.47~5.45 mmol/L ,n= 30) .Influencing factors for PON3 and ApoA1 were analyzed by multivariate linear regression analysis . Results (1)The SBP ,DBP ,FPG ,2 hPG ,HbA1c ,FIns ,ApoB ,BUN ,HOMA-IR , ApoA1 and number of smokers were higher in T2DM + CHD group than in NC group .FPG ,2 hPG ,HbA1c ,FIns and HOMA-IR were higher in T2DM+ CHD group than in T2DM group(P<0.05 or P<0.01) .LDL-C ,Lp-a and hsC-RP were higher ,and the PON3 were lower in T2DM +CHD group than in T2DM group and NC group (P< 0.05 or P< 0.01);(2)With the increase of blood glucose fluctuation range ,the levels of PON3[(0.58 ± 0.10) vs (0.44 ± 0.07) vs (0.25 ± 0.01) ng/ml]and ApoA1 [(2.33 ± 1.04) vs (2.31 ± 0.71) vs(1.05 ± 0.48)g/L]were reduced(all P=0.000);(3)Multiple linear regression analysis showed that BMI ,hsC-RP ,HOMA-IR and MAGE were influencing factors for PON3. And HbA1c ,hsC-RP and MAGE were influencing factors for ApoA1 (P<0.05 or P<0.01) . Conclusion Serum PON3 level is lower and ApoA1 level is higher in T2DM patients with CHD .Glucose fluctuation may be only an influencing factor for ApoA1 level .

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