Meta-analysis of individual patient data to assess the risk of hypoglycaemia in people with type 2 diabetes using NPH insulin or insulin glargine

Diabetes, Obesity and Metabolism

Volumn 12, Issue 9, 2010, Pages 772-779

  Home, P D ^a   Fritsche, A ^b   Schinzel, S ^c   Massi Benedetti, M ^d  

^a NEWCASTLE UNIVERSITY   (United Kingdom)

^b UNIVERSITY OF TÜBINGEN   (Germany)

^c SANOFI AVENTIS DEUTSCHLAND GMBH   (Germany)

^d UNIVERSITY OF PERUGIA   (Italy)

Author keywords

Type 2 diabetes

Indexed keywords

HEMOGLOBIN A1C; INSULIN GLARGINE; ISOPHANE INSULIN; ORAL ANTIDIABETIC AGENT;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE SEVERITY; EVENING DOSAGE; HUMAN; HYPOGLYCEMIA; INCIDENCE; MEDICAL LITERATURE; META ANALYSIS; MORNING DOSAGE; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; SYSTEMATIC REVIEW;

EID: 77955031968     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2010.01232.x     Document Type: Article

References (42)

1. Frier BM. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab Res Rev 2008, 24:87-92.
2. Cryer PE. Hypoglycemia, functional brain failure, and brain death. J Clin Invest 2007, 117:868-870.
3. MacLeod KM. Hypoglycaemia unawareness: causes, consequences and treatment. J R Coll Physicians Lond 2000, 34:245-250.
4. Gabriely I, Shamoon H. Hypoglycemia in diabetes: common, often unrecognized. Cleve Clin J Med 2004, 71:335-342.
5. Davis RE, Morrissey M, Peters JR, Wittrup-Jensen K, Kennedy-Martin T, Currie CJ. Impact of hypoglycaemia on quality of life and productivity in type 1 and type 2 diabetes. Curr Med Res Opin 2005, 21:1477-1483.
6. Svensson AM, McGuire DK, Abrahamsson P, Dellborg M. Association between hyper- and hypoglycaemia and 2 year all-cause mortality risk in diabetic patients with acute coronary events. Eur Heart J 2005, 26:1255-1261.
7. Bonds DE, Miller ME, Bergenstal RM. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ 2010, 340:b4909.
8. Amiel SA, Dixon T, Mann R, Jameson K. Hypoglycaemia in Type 2 diabetes. Diabet Med 2008, 25:245-254.
9. Stratton IM, Kohner EM, Aldington SJ. UKPDS 50: risk factors for incidence and progression of retinopathy in Type II diabetes over 6 years from diagnosis. Diabetologia 2001, 44:156-163.
10. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-Year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008, 359:1577-1589.
11. Ray KK, Seshasai SR, Wijesuriya S. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet 2009, 373:1765-1772.
12. Nathan DM, Buse JB, Davidson MB. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009, 32:193-203.
13. Owens DR, Zinman B, Bolli GB. Insulins today and beyond. Lancet 2001, 358:739-746.
14. Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003, 26:3080-3086.
15. Massi-Benedetti M, Humburg E, Dressler A, Ziemen M. A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Horm Metab Res 2003, 35:189-196.
16. Rosenstock J, Schwartz SL, Clark CM. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care 2001, 24:631-636.
17. Yki-Järvinen H, Dressler A, Ziemen M. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group. Diabetes Care 2000, 23:1130-1136.
18. Fritsche A, Schweitzer M, Haring H-U. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med 2003, 138:952-959.
19. Mullins P, Sharplin P, Yki-Jarvinen H, Riddle MC, Haring HU. Negative binomial meta-regression analysis of combined glycosylated hemoglobin and hypoglycemia outcomes across eleven Phase III and IV studies of insulin glargine compared with neutral protamine Hagedorn insulin in type 1 and type 2 diabetes mellitus. Clin Ther 2007, 29:1607-1619.
20. Bottomley JM, Raymond FD. Pharmaco-economic issues for diabetes therapy. Best Pract Res Clin Endocrinol Metab 2007, 21:657-685.
21. Miller DR, Gardner JA, Hendricks AM, Zhang Q, Fincke BG. Health care resource utilization and expenditures associated with the use of insulin glargine. Clin Ther 2007, 29:478-487.
22. Brandle M, Azoulay M, Greiner RA. Cost-effectiveness and cost-utility of insulin glargine compared with NPH insulin based on a 10-year simulation of long-term complications with the Diabetes Mellitus Model in patients with type 2 diabetes in Switzerland. Int J Clin Pharmacol Ther 2007, 45:203-220.
23. Lambert PC, Sutton AJ, Abrams KR, Jones DR. A comparison of summary patient-level covariates in meta-regression with individual patient data meta-analysis. J Clin Epidemiol 2002, 55:86-94.
24. Berlin JA, Santanna J, Schmid CH, Szczech LA, Feldman HI. Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head. Stat Med 2002, 21:371-387.
25. Higgins JP, Thompson SG. Controlling the risk of spurious findings from meta-regression. Stat Med 2004, 23:1663-1682.
26. Altman DG, Schulz KF, Moher D. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001, 134:663-694.
27. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001, 134:657-662.
28. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 1999, 354:1896-1900.
29. Cochrane Handbook for Systematic Reviews of Interventions 4.2.6 (updated September 2006). http://www.cochrane.de, The Cochrane Collaboration., Availableat
30. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002, 21:1539-1558.
31. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003, 327:557-560.
32. Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ 1995, 310:452-454.
33. Yki-Järvinen H, Kauppinen-Makelin R, Tiikkainen M. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006, 49:442-451.
34. Eliaschewitz FG, Calvo C, Valbuena H. Therapy in type 2 diabetes: insulin glargine vs. NPH insulin both in combination with glimepiride. Arch Med Res 2006, 37:495-501.
35. Pan CY, Sinnassamy P, Chung KD, Kim KW. Insulin glargine versus NPH insulin therapy in Asian Type 2 diabetes patients. Diabetes Res Clin Pract 2007, 76:111-118.
36. Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care 1987, 10:617-621.
37. Jones TW, Porter P, Sherwin RS. Decreased epinephrine responses to hypoglycemia during sleep. N Engl J Med 1998, 338:1657-1662.
38. Rhoads GG, Orsini LS, Crown W, Wang S, Getahun D, Zhang Q. Contribution of hypoglycemia to medical care expenditures and short-term disability in employees with diabetes. J Occup Environ Med 2005, 47:447-452.
39. Heaton A, Martin S, Brelje T. The economic effect of hypoglycemia in a health plan. Manag Care Interface 2003, 16:23-27.
40. Lundkvist J, Berne C, Bolinder B, Jonsson L. The economic and quality of life impact of hypoglycemia. Eur J Health Econ 2005, 6:197-202.
41. Type 2 diabetes. National clinical guideline for management in primary and secondary care (update) Appendix C: Health exonomic analysis of third-line therapy with insulins glitazones or exematide in Type 2 diabetes. http://www.nice.org.uk/nicemedia/pdf/CG66diabetesappendices.pdf, National Institute for Health and Clinical Excellence (NICE)., London, NICE, Available at:, Accessed 2008.
42. Appendix 2- Technology assessment report. Type 2 diabetes: new agents. http://www.nice.org.uk/nicemedia/pdf/CG87ShortGuidelineAppendices.pdf, National Institute for Health and Clinical Excellence (NICE)., London, Nice, Available at:, Accessed 2009.