Effectiveness and Safety of Nateglinide for Type 2 Diabetes Mellitus: A Meta-Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 WUMan ,  MAJian-li , LIUGui-yang , SHAOJie

Department of Pharmacy, First Hospital Affiliated to PLA General Hospital, Beijing 100048, China;

Corresponding author：

MAJian-li, Email: Jianli.ma@163.com

Keywords：

Nateglinide; Mitiglinide; Type 2 diabetes mellitus; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20140162

Video：

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Objective To systematically review the effectiveness and safety of nateglinide versus mitiglinide in patients with type 2 diabetes mellitus (T2DM). Methods Such databases as PubMed, EMbase, MEDLINE, The Cochrane Library (Issue 3, 2013), CNKI, VIP and WanFang Data were searched through computer to investigate references and collect randomized controlled trials (RCTs) about nateglinide (trial group) compared with mitiglinide (control group) in treating T2DM from the date of their establishment to October 2013. Literature screening according to the inclusion and exclusion criteria, data extraction and methodological quality assessment of the included studies were completed by two reviewers independently. Meta-analysis was then conducted using RevMan 5.2 software. Results A total of eight RCTs involving 966 patients were included. The results of meta-analysis indicated that: a) the effects of nateglinide were similar to those of mitiglinide in lowering FPG (WMD=0.07, 95%CI-0.19 to 0.34, P=0.58), 2hPG (WMD=0.33, 95%CI-0.22 to 0.87, P=0.24), and HbA1c (WMD=0.11, 95%CI-0.03 to 0.25, P=0.12). b) In both groups, insulin resistance levels were lowered down, B-cell function was improved, and oxidative stress was significantly suppressed. c) No significant difference was found between the two groups in the incidences of hypoglycemia (OR=1.49, 95%CI 0.85 to 2.60, P=0.17) and gastrointestinal adverse reaction (OR=-0.80, 95%CI 0.37 to 1.75, P=0.58). Conclusion Nateglinide and mitiglinide have the similar effectiveness and safety in the treatment of T2DM. Due to the limited quantity and quality of the included studies, the above conclusion should be probed by more large-scale multicenter high quality studies in future.

Citation： WUMan, MAJian-li, LIUGui-yang, SHAOJie. Effectiveness and Safety of Nateglinide for Type 2 Diabetes Mellitus: A Meta-Analysis. Chinese Journal of Evidence-Based Medicine, 2014, 14(8): 984-990. doi: 10.7507/1672-2531.20140162 Copy

1.	Chung KF, Barnes PJ. Cylokines in asthma. Thorax, 1999, 54(9): 825-857.
2.	Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med, 1998, 15(7): 539-553.
3.	American Diabetes Association. Standards of medical care in diabetes, 2007. Diabetes Care, 2007, 30(Suppl 1): S4-S41.
4.	Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane hand-book for systematic reviews of interventions version 5.1.0 (updated Sep 2011). The Cochrane Collaboration. 2011.
5.	吕肖锋, 姚璐, 朱旅云, 等.米格列奈钙片治疗2型糖尿病的安全性及有效性的临床研究.中国临床药理学与治疗学, 2009, 14(2): 175-179.
6.	朱显军, 张学军, 李蓬秋.国产米格列奈钙片治疗2型糖尿病患者的疗效观察.四川医学, 2012, 33(1): 55-57.
7.	王广宇, 朱旅云, 马利成, 等.米格列奈治疗2型糖尿病临床试验研究.临床内科杂志, 2006, 23(12): 812-814.
8.	陈道雄, 刘海蔚, 方团育, 等.米格列奈治疗初发2型糖尿病的疗效观察.实用糖尿病杂志, 2012, 8(6): 38-39.
9.	陈允真.米格列奈和那格列奈对2型糖尿病患者血糖水平及氧化应激指标的影响.山东医药, 2010, 50(35): 75-76.
10.	周嘉, 梁杏欢, 秦映芬, 等.米格列奈和那格列奈对2型糖尿病患者氧化应激指标的影响.广东医学, 2009, 30(11): 1737-1739.
11.	Li L, Yang M, Li Z, et al. Efficacy and safety of mitiglinide versus nateglinide in newly diagnose patients With Type 2 diabetes mellitus: A randomized double blind trial. Diabetes, Obesity and Metabolism, 2012, 14(2): 187-189.
12.	Xin G, Liu ZM, Li GW, et al. Multicentre, double-blind, randomized study of mitiglinide compared with nateglinide in type 2 diabetes mellitus patients in China. Journal of International Medical Research, 2009, 37(3): 812-821.
13.	杨惠娣, 徐彬. 2型糖尿病治疗新药-那格列奈.世界临床药物, 2004, 25(9): 564-567.
14.	Ryden L, Standl E, Bartnik M, et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J, 2007, 28(1): 88-136.
15.	Mattews DR, Boland O. The stimulation of insulin secration in non-insulin-dependent diabetic patients by amino acids and gliclazicle in the basai and hyperglycemic atste. Metabolism, 1997, 46(12): 5-9.
16.	Shikai H, Nishikawa M, Sato Y, et al. N-(cyclohexylcarbonyl)-D-phenylalanines and related componds. A new class of oral hypoglycemic agents. Med Chem, 1989, 32(7): 1436-1441.
17.	Sato Y, Nishikawa M, Shinkai H, et al. Possibility of ideal blood glucose control by a new oral hypoglycemic agent, N-(trans-4-isopropylcycohexy)-carbonyl-D-phenylalanine(A-4166), and its stimulatory effect on insulin secretion in animals. Diabetes Res Clin Pract, 1991, 12(1): 53-59.
18.	王甫能, 廖志红, 胡国亮, 等.控制血糖对2型糖尿病患者胰岛β细胞功能的改善作用—那格列奈和瑞格列奈的双盲随机对照研究.中华内分泌代谢杂志, 2005, 10(21): 428-431.
19.	邱奇.检测糖化血红蛋白对糖尿病治疗方案及疗效评价的意义探讨.中国实用医药, 2008, 3(7): 61-62.
20.	方中良, 沈干, 胡世莲, 等.罗格列酮治疗2型糖尿病伴原发性高血压患者效果的Meta分析.中国循证医学杂志, 2011, 11(9): 1012-1020.
21.	王凌云, 柳洁.氧化应激在糖尿病肾病中的意义及吡格列酮干预研究.山西医药杂志, 2008, 37 (4): 11.
22.	Assaloni R, Da Ros R, Quagliaro L, et al. Effects of mitiglinide on postprandial generation of oxidative stress and inflammation in type 2 diabetic patients. Diabetologia, 2005, 48(9): 1919-1924.
23.	金静, 罗佐杰.氧化应激对胰岛β细胞影响的研究进展.山东医药, 2009, 49(37): 108-109.
24.	殷霞, 李建薇, 喻红玲, 等.那格列奈和瑞格列奈对2型糖尿病患者血清MDA水平和SOD活性的影响.华西药学杂志, 2005, 20(6): 500-502.
25.	Davies M. Nateglinid: better post prandial glucosecontrol. Prescriber, 2002, 13(2): 17-27.
26.	李吉, 孙家忠, 李广森, 等.西格列汀联合二甲双胍治疗2型糖尿病效果的系统评价.中国循证医学杂志, 2013, 13(7): 836-843.

1. Chung KF, Barnes PJ. Cylokines in asthma. Thorax, 1999, 54(9): 825-857.
2. Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med, 1998, 15(7): 539-553.
3. American Diabetes Association. Standards of medical care in diabetes, 2007. Diabetes Care, 2007, 30(Suppl 1): S4-S41.
4. Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane hand-book for systematic reviews of interventions version 5.1.0 (updated Sep 2011). The Cochrane Collaboration. 2011.
5. 吕肖锋, 姚璐, 朱旅云, 等.米格列奈钙片治疗2型糖尿病的安全性及有效性的临床研究.中国临床药理学与治疗学, 2009, 14(2): 175-179.
6. 朱显军, 张学军, 李蓬秋.国产米格列奈钙片治疗2型糖尿病患者的疗效观察.四川医学, 2012, 33(1): 55-57.
7. 王广宇, 朱旅云, 马利成, 等.米格列奈治疗2型糖尿病临床试验研究.临床内科杂志, 2006, 23(12): 812-814.
8. 陈道雄, 刘海蔚, 方团育, 等.米格列奈治疗初发2型糖尿病的疗效观察.实用糖尿病杂志, 2012, 8(6): 38-39.
9. 陈允真.米格列奈和那格列奈对2型糖尿病患者血糖水平及氧化应激指标的影响.山东医药, 2010, 50(35): 75-76.
10. 周嘉, 梁杏欢, 秦映芬, 等.米格列奈和那格列奈对2型糖尿病患者氧化应激指标的影响.广东医学, 2009, 30(11): 1737-1739.
11. Li L, Yang M, Li Z, et al. Efficacy and safety of mitiglinide versus nateglinide in newly diagnose patients With Type 2 diabetes mellitus: A randomized double blind trial. Diabetes, Obesity and Metabolism, 2012, 14(2): 187-189.
12. Xin G, Liu ZM, Li GW, et al. Multicentre, double-blind, randomized study of mitiglinide compared with nateglinide in type 2 diabetes mellitus patients in China. Journal of International Medical Research, 2009, 37(3): 812-821.
13. 杨惠娣, 徐彬. 2型糖尿病治疗新药-那格列奈.世界临床药物, 2004, 25(9): 564-567.
14. Ryden L, Standl E, Bartnik M, et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J, 2007, 28(1): 88-136.
15. Mattews DR, Boland O. The stimulation of insulin secration in non-insulin-dependent diabetic patients by amino acids and gliclazicle in the basai and hyperglycemic atste. Metabolism, 1997, 46(12): 5-9.
16. Shikai H, Nishikawa M, Sato Y, et al. N-(cyclohexylcarbonyl)-D-phenylalanines and related componds. A new class of oral hypoglycemic agents. Med Chem, 1989, 32(7): 1436-1441.
17. Sato Y, Nishikawa M, Shinkai H, et al. Possibility of ideal blood glucose control by a new oral hypoglycemic agent, N-(trans-4-isopropylcycohexy)-carbonyl-D-phenylalanine(A-4166), and its stimulatory effect on insulin secretion in animals. Diabetes Res Clin Pract, 1991, 12(1): 53-59.
18. 王甫能, 廖志红, 胡国亮, 等.控制血糖对2型糖尿病患者胰岛β细胞功能的改善作用—那格列奈和瑞格列奈的双盲随机对照研究.中华内分泌代谢杂志, 2005, 10(21): 428-431.
19. 邱奇.检测糖化血红蛋白对糖尿病治疗方案及疗效评价的意义探讨.中国实用医药, 2008, 3(7): 61-62.
20. 方中良, 沈干, 胡世莲, 等.罗格列酮治疗2型糖尿病伴原发性高血压患者效果的Meta分析.中国循证医学杂志, 2011, 11(9): 1012-1020.
21. 王凌云, 柳洁.氧化应激在糖尿病肾病中的意义及吡格列酮干预研究.山西医药杂志, 2008, 37 (4): 11.
22. Assaloni R, Da Ros R, Quagliaro L, et al. Effects of mitiglinide on postprandial generation of oxidative stress and inflammation in type 2 diabetic patients. Diabetologia, 2005, 48(9): 1919-1924.
23. 金静, 罗佐杰.氧化应激对胰岛β细胞影响的研究进展.山东医药, 2009, 49(37): 108-109.
24. 殷霞, 李建薇, 喻红玲, 等.那格列奈和瑞格列奈对2型糖尿病患者血清MDA水平和SOD活性的影响.华西药学杂志, 2005, 20(6): 500-502.
25. Davies M. Nateglinid: better post prandial glucosecontrol. Prescriber, 2002, 13(2): 17-27.
26. 李吉, 孙家忠, 李广森, 等.西格列汀联合二甲双胍治疗2型糖尿病效果的系统评价.中国循证医学杂志, 2013, 13(7): 836-843.

Chinese Journal of Evidence-Based Medicine

Effectiveness and Safety of Nateglinide for Type 2 Diabetes Mellitus: A Meta-Analysis

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