Biphasic Insulin Aspart 30 Given Three Times Daily for Type 2 Diabetes: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Lan , OUYANG Xiaobo ,  HE Jidong

Department of Endocrinology, the Second People’s Hospital of Yaan, Yaan 625000, China;

Corresponding author：

HE Jidong, Email: hjdshare@sina.com

Keywords：

Biphasic insulin aspart 30; Type 2 diabetes; Systematic review; Meta-analysis

DOI：

10.7507/1672-2531.20120126

Video：

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Objective 　To assess the effectiveness and safety of biphasic insulin aspart 30 given three times a day in the management of type 2 diabetes.
Methods 　Such databases as CENTRAL, MEDLINE, PubMed and CNKI were searched on computer; additionally, the relevant conference proceedings from associations like American Diabetes Association, and the references of all selected literatures were also hand-searched. The randomized controlled trials (RCTs) on biphasic insulin aspart 30 given three times a day in treating type 2 diabetes were screened according to inclusive and exclusive criteria, without concerning the limitation of languages and blind methods. After data extraction and quality evaluation, Meta-analysis was performed by using RevMan 4.2 software.
Results 　Ten trials involving 1 415 patients were included. The sub-group analysis showed that compared with the group of given biphasic insulin aspart 30 twice a day (the bid group), the group of given biphasic insulin aspart 30 three times a day (the tid group) was superior in decreasing HbAlc (P lt;0.000 01). Compared with the group of thrice preprandial injection of Novolin R plus one injection of Novolin N at bedtime (the qid group), Meta-analysis showed that, a) As to the average fasting glucose levels: the tid group was not superior to the qid group (P=0.65); b) As to the average 2-hour postprandial glucose levels: the tid group was superior to the qid group (P=0.0003); c) As to the therapeutic time: the tid group was not superior to the qid group (P=0.38); d) As to the insulin doses: the tid group was superior to the qid group (P=0.000 1); e) As to the insulin costs: the tid group was inferior to the qid group (P=0.02); and e) As to the incidence of hypoglycaemia: the tid group was superior to the qid group (P=0.000 2). Compared with the oral antidiabetic drugs, the results of Meta-analyses showed: the tid group was superior in decreasing HbAlc (P=0.001).
Conclusion 　The limited current evidence shows that biphasic insulin aspart 30 given three times a day, as a simple insulin intensified scheme, is safe and effective for type 2 diabetes, and is worth recommending in clinic. However, all these findings should be further confirmed with more large sample and well-designed RCTs.

Citation： ZHANG Lan,OUYANG Xiaobo,HE Jidong. Biphasic Insulin Aspart 30 Given Three Times Daily for Type 2 Diabetes: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2012, 12(7): 822-829. doi: 10.7507/1672-2531.20120126 Copy

1.	Natban DM. Clinical: practice initial management of glycemia intype 2 diabetes mellitus. N Engl J Med, 2002, 347: 1342-1349.
2.	Edmond AR, Sharleen I, Clarissa W. Shoa Term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes. Diabetes Care, 2004, 27: 1028-1032.
3.	翁建平. 短期持续胰岛素输注治疗对初诊2型糖尿病患者胰岛B细胞功能的影响. 中国糖尿病杂志, 2003, 11(1): 10-14.
4.	KhutsoaIle D, Sharma SK, Mmustda M, et al. Biphasic insulin aspaIt 30 treament improves glyeaemic control in paient with type 2 diabetesin a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab, 2008, 10(3): 212-222.
5.	Garber AJ , Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once 2, twice 2, or thrice-daily dosing with biphasic insulin aspart 70/30 (the 1-2-3 study). Diabetes Obes Metab, 2006, 8: 58-66.
6.	Yang WY, Chen LL, Ji QH, et al. Biphasic Insulin Aspart 30 Three Times Daily Is More Effective Than a Twice-Daily Regimen, Without Increasing Hypoglycemia, in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Drugs. Diabetes Care, 2008, 31: 852-856.
7.	马新春, 刘志明. 诺和锐30日二次和三次注射对初诊II型糖尿病血糖波动的影响. Clinical Journal, 2009, 18(12): 96-99.
8.	李焱, 梁骏, 梁颖, 等. 三种胰岛素强化治疗方案的短期疗效和安全性比较. 中华内分泌代谢杂志, 2008, 24(6): 620-622.
9.	张灵建, 王瑾, 陈华, 等. 每日3次诺和锐3 O治疗2型糖尿病疗效观察. 中国糖尿病杂志, 2008, 16(12): 744-746.
10.	黄伟魄. 诺和锐30强化治疗2型糖尿病15例临床观察. 福建医药杂志, 2009, 31(5): 115-117.
11.	杜琳, 谢梅, 艾隽. 诺和锐30与诺和灵R、N强化治疗临床疗效与安全性对比研究. 新疆医学, 2006, 36: 161-162.
12.	尤巧英, 朱麒钱, 斯徐伟. 诺和锐3O与诺和灵R/N强化治疗初诊2型糖尿病的临床比较. 海峡药学. 2008, 20(11): 89-90.
13.	张玲玲, 白莉萍, 任海. 诺和锐3O与重组人胰岛素强化治疗2型糖尿病临床比较. 山西医药杂志, 2009, 38: 40-41.
14.	Ushakova O, Sokolovskaya V, Morozova A, et al. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in russia. Chin Ther, 2007, 29(11): 2374-2384.
15.	玛依努, 努荣古丽, 吾甫尔江. 应用诺和锐30对新疆地区初诊的维吾尔族2型糖尿病患者强化治疗的临床观察. 新疆医学, 2008, 38: 95-97.
16.	UK prospective diabetes study 16 Overview of 6 years therapy of type Ⅱ diabetes: a progressive disease. Diabetes, 1995, 44: 1249-1258.
17.	The DCCT Research Group. The effect of intensive treatmentof diabetes on the development and progression of long—term complications in insulin—dependent diabetes mellitus. N Engl J Med, 1993, 329: 977-986．.
18.	The DCCT/ED1C Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med, 2005, 353: 2643-2653．.
19.	Stratton IM , Adler AI, Neil HA, et al. Association of glycemia with macrovascular and microvascular complications of type 2diabetes (UKPDS 35): prospective observational study. Br Med J, 2000, 321: 405-412．.
20.	Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med, 2008, 358(24): 2545-2559.

1. Natban DM. Clinical: practice initial management of glycemia intype 2 diabetes mellitus. N Engl J Med, 2002, 347: 1342-1349.
2. Edmond AR, Sharleen I, Clarissa W. Shoa Term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes. Diabetes Care, 2004, 27: 1028-1032.
3. 翁建平. 短期持续胰岛素输注治疗对初诊2型糖尿病患者胰岛B细胞功能的影响. 中国糖尿病杂志, 2003, 11(1): 10-14.
4. KhutsoaIle D, Sharma SK, Mmustda M, et al. Biphasic insulin aspaIt 30 treament improves glyeaemic control in paient with type 2 diabetesin a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab, 2008, 10(3): 212-222.
5. Garber AJ , Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once 2, twice 2, or thrice-daily dosing with biphasic insulin aspart 70/30 (the 1-2-3 study). Diabetes Obes Metab, 2006, 8: 58-66.
6. Yang WY, Chen LL, Ji QH, et al. Biphasic Insulin Aspart 30 Three Times Daily Is More Effective Than a Twice-Daily Regimen, Without Increasing Hypoglycemia, in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Drugs. Diabetes Care, 2008, 31: 852-856.
7. 马新春, 刘志明. 诺和锐30日二次和三次注射对初诊II型糖尿病血糖波动的影响. Clinical Journal, 2009, 18(12): 96-99.
8. 李焱, 梁骏, 梁颖, 等. 三种胰岛素强化治疗方案的短期疗效和安全性比较. 中华内分泌代谢杂志, 2008, 24(6): 620-622.
9. 张灵建, 王瑾, 陈华, 等. 每日3次诺和锐3 O治疗2型糖尿病疗效观察. 中国糖尿病杂志, 2008, 16(12): 744-746.
10. 黄伟魄. 诺和锐30强化治疗2型糖尿病15例临床观察. 福建医药杂志, 2009, 31(5): 115-117.
11. 杜琳, 谢梅, 艾隽. 诺和锐30与诺和灵R、N强化治疗临床疗效与安全性对比研究. 新疆医学, 2006, 36: 161-162.
12. 尤巧英, 朱麒钱, 斯徐伟. 诺和锐3O与诺和灵R/N强化治疗初诊2型糖尿病的临床比较. 海峡药学. 2008, 20(11): 89-90.
13. 张玲玲, 白莉萍, 任海. 诺和锐3O与重组人胰岛素强化治疗2型糖尿病临床比较. 山西医药杂志, 2009, 38: 40-41.
14. Ushakova O, Sokolovskaya V, Morozova A, et al. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in russia. Chin Ther, 2007, 29(11): 2374-2384.
15. 玛依努, 努荣古丽, 吾甫尔江. 应用诺和锐30对新疆地区初诊的维吾尔族2型糖尿病患者强化治疗的临床观察. 新疆医学, 2008, 38: 95-97.
16. UK prospective diabetes study 16 Overview of 6 years therapy of type Ⅱ diabetes: a progressive disease. Diabetes, 1995, 44: 1249-1258.
17. The DCCT Research Group. The effect of intensive treatmentof diabetes on the development and progression of long—term complications in insulin—dependent diabetes mellitus. N Engl J Med, 1993, 329: 977-986．.
18. The DCCT/ED1C Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med, 2005, 353: 2643-2653．.
19. Stratton IM , Adler AI, Neil HA, et al. Association of glycemia with macrovascular and microvascular complications of type 2diabetes (UKPDS 35): prospective observational study. Br Med J, 2000, 321: 405-412．.
20. Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med, 2008, 358(24): 2545-2559.

Chinese Journal of Evidence-Based Medicine

Biphasic Insulin Aspart 30 Given Three Times Daily for Type 2 Diabetes: A Systematic Review

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