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.	呂肖鋒, 姚璐, 朱旅云, 等.米格列奈鈣片治療2型糖尿病的安全性及有效性的臨床研究.中國臨床藥理學與治療學, 2009, 14(2): 175-179.
6.	朱顯軍, 張學軍, 李蓬秋.國產米格列奈鈣片治療2型糖尿病患者的療效觀察.四川醫學, 2012, 33(1): 55-57.
7.	王廣宇, 朱旅云, 馬利成, 等.米格列奈治療2型糖尿病臨床試驗研究.臨床內科雜志, 2006, 23(12): 812-814.
8.	陳道雄, 劉海蔚, 方團育, 等.米格列奈治療初發2型糖尿病的療效觀察.實用糖尿病雜志, 2012, 8(6): 38-39.
9.	陳允真.米格列奈和那格列奈對2型糖尿病患者血糖水平及氧化應激指標的影響.山東醫藥, 2010, 50(35): 75-76.
10.	周嘉, 梁杏歡, 秦映芬, 等.米格列奈和那格列奈對2型糖尿病患者氧化應激指標的影響.廣東醫學, 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.	楊惠娣, 徐彬. 2型糖尿病治療新藥-那格列奈.世界臨床藥物, 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, 廖志紅, 胡國亮, 等.控制血糖對2型糖尿病患者胰島β細胞功能的改善作用—那格列奈和瑞格列奈的雙盲隨機對照研究.中華內分泌代謝雜志, 2005, 10(21): 428-431.
19.	邱奇.檢測糖化血紅蛋白對糖尿病治療方案及療效評價的意義探討.中國實用醫藥, 2008, 3(7): 61-62.
20.	方中良, 沈干, 胡世蓮, 等.羅格列酮治療2型糖尿病伴原發性高血壓患者效果的Meta分析.中國循證醫學雜志, 2011, 11(9): 1012-1020.
21.	王凌云, 柳潔.氧化應激在糖尿病腎病中的意義及吡格列酮干預研究.山西醫藥雜志, 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.	金靜, 羅佐杰.氧化應激對胰島β細胞影響的研究進展.山東醫藥, 2009, 49(37): 108-109.
24.	殷霞, 李建薇, 喻紅玲, 等.那格列奈和瑞格列奈對2型糖尿病患者血清MDA水平和SOD活性的影響.華西藥學雜志, 2005, 20(6): 500-502.
25.	Davies M. Nateglinid: better post prandial glucosecontrol. Prescriber, 2002, 13(2): 17-27.
26.	李吉, 孫家忠, 李廣森, 等.西格列汀聯合二甲雙胍治療2型糖尿病效果的系統評價.中國循證醫學雜志, 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. 呂肖鋒, 姚璐, 朱旅云, 等.米格列奈鈣片治療2型糖尿病的安全性及有效性的臨床研究.中國臨床藥理學與治療學, 2009, 14(2): 175-179.
6. 朱顯軍, 張學軍, 李蓬秋.國產米格列奈鈣片治療2型糖尿病患者的療效觀察.四川醫學, 2012, 33(1): 55-57.
7. 王廣宇, 朱旅云, 馬利成, 等.米格列奈治療2型糖尿病臨床試驗研究.臨床內科雜志, 2006, 23(12): 812-814.
8. 陳道雄, 劉海蔚, 方團育, 等.米格列奈治療初發2型糖尿病的療效觀察.實用糖尿病雜志, 2012, 8(6): 38-39.
9. 陳允真.米格列奈和那格列奈對2型糖尿病患者血糖水平及氧化應激指標的影響.山東醫藥, 2010, 50(35): 75-76.
10. 周嘉, 梁杏歡, 秦映芬, 等.米格列奈和那格列奈對2型糖尿病患者氧化應激指標的影響.廣東醫學, 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. 楊惠娣, 徐彬. 2型糖尿病治療新藥-那格列奈.世界臨床藥物, 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, 廖志紅, 胡國亮, 等.控制血糖對2型糖尿病患者胰島β細胞功能的改善作用—那格列奈和瑞格列奈的雙盲隨機對照研究.中華內分泌代謝雜志, 2005, 10(21): 428-431.
19. 邱奇.檢測糖化血紅蛋白對糖尿病治療方案及療效評價的意義探討.中國實用醫藥, 2008, 3(7): 61-62.
20. 方中良, 沈干, 胡世蓮, 等.羅格列酮治療2型糖尿病伴原發性高血壓患者效果的Meta分析.中國循證醫學雜志, 2011, 11(9): 1012-1020.
21. 王凌云, 柳潔.氧化應激在糖尿病腎病中的意義及吡格列酮干預研究.山西醫藥雜志, 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. 金靜, 羅佐杰.氧化應激對胰島β細胞影響的研究進展.山東醫藥, 2009, 49(37): 108-109.
24. 殷霞, 李建薇, 喻紅玲, 等.那格列奈和瑞格列奈對2型糖尿病患者血清MDA水平和SOD活性的影響.華西藥學雜志, 2005, 20(6): 500-502.
25. Davies M. Nateglinid: better post prandial glucosecontrol. Prescriber, 2002, 13(2): 17-27.
26. 李吉, 孫家忠, 李廣森, 等.西格列汀聯合二甲雙胍治療2型糖尿病效果的系統評價.中國循證醫學雜志, 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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