Intensification of insulin therapy with basal-bolus or premixed insulin regimens in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials (original) (raw)

References

1. E.W. Gregg, X. Zhuo, Y.J. Cheng, A.L. AlbrighL, K.M. Narayan, T.J. Thompson, Trends in lifetime risk and years of life lost due to diabetes in the USA, 1985–2011: a modelling study. Lancet Diabetes Endocrinol 2, 867–874 (2014)
   Article PubMed Google Scholar
2. American Diabetes Association, 7. Approaches to glycemic treatment. Diabetes Care 38(Suppl. 1), S41–S48 (2015)
   Article Google Scholar
3. L.W. Turner, D. Nartey, R.S. Stafford, S. Singh, G.C. Alexander, Ambulatory treatment of type 2 diabetes in the U.S., 1997–2012. Diabetes Care 37, 985–992 (2014)
   Article PubMed Central PubMed Google Scholar
4. K. Esposito, P. Chiodini, G. Bellastella, M.I. Maiorino, D. Giugliano, Proportion of patients at HbA1c target <7 % with eight classes of antidiabetic drugs in type 2 diabetes: systematic review of 218 randomized controlled trials with 78,945 patients. Diabetes Obes. Metab. 14, 228–233 (2012)
   Article CAS PubMed Google Scholar
5. P. de Pablos-Velasco, K.G. Parhofer, C. Bradley, E. Eschwège, L. Gönder-Frederick, P. Maheux, I. Wood, D. Simon, Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study. Clin. Endocrinol. (Oxf.) 80, 47–56 (2014)
   Article Google Scholar
6. American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD), S.E. Inzucchi, R.M. Bergenstal, J.B. Buse, E. Diamant, M. Ferrannini, A.L. Nauck, A. Peters, R. Tsapas, R. Wender, D.R. Matthews, Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 35, 1364–1379 (2012)
   Article Google Scholar
7. Orals Plus Apidra and LANTUS (OPAL) study group, M.R. Lankisch, K.C. Ferlinz, J.L. Leahy, W.A. Scherbaum, Introducing a simplified approach to insulin therapy in type 2 diabetes: a comparison of two single dose regimens of insulin glulisine plus insulin glargine and oral antidiabetic drugs. Diabetes Obes. Metab. 10, 1178–1185 (2008)
   Google Scholar
8. M.B. Davidson, P. Raskin, R.J. Tanenberg, A. Vlajnic, P. Hollander, A stepwise approach to insulin therapy in patients with type 2 diabetes mellitus and basal insulin treatment failure. Endocr. Pract. 17, 395–403 (2001)
   Article Google Scholar
9. A.J. Garber, J. Wahlen, T. Wahl, P. Bressler, R. Braceras, E. Allen, R. Jain, Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study). Diabetes Obes. Metab. 8, 58–66 (2006)
   Article CAS PubMed Google Scholar
10. O. Mosenzon, I. Raz, Intensification of insulin therapy for type 2 diabetic patients in primary care: basal-bolus regimen versus premix insulin analogs: when and for whom? Diabetes Care 36(Suppl 2), S212–S218 (2013)
    Article PubMed Central CAS PubMed Google Scholar
11. B.T. Blak, H.T. Smith, M. Hards, A. Maguire, V. Gimeno, A retrospective database study of insulin initiation in patients with Type 2 diabetes in UK primary care. Diabet. Med. 29, e191–e198 (2012)
    Article CAS PubMed Google Scholar
12. P.D. Home, M.-P. Dain, N. Freemantle, R. Kawamori, M. Pfohl, S. Brette, V. Pilorget, W.A. Scherbaum, G. Vespasiani, M. Vincent, B. Balkau, Four-year evolution of insulin regimens, glycaemic control, hypoglycaemia and body weight after starting insulin therapy in type 2 diabetes across three continents. Diabetes Res. Clin. Pract. (2015). doi:10.1016/j.diabres.2015.01.030
    Google Scholar
13. J.L. Li, W. Jia, J. Weng, Glycemic control in insulinized type 2 diabetes patients in China: one-year results from IDMPS. American Diabetes Association 69th Scientific Sessions, New Orleans, 2009
14. A. Liberati, D.G. Altman, J. Tetzlaff, C. Mulrow, P.C. Gøtzsche, J.P. Ioannidis, M. Clarke, P.J. Devereaux, J. Kleijnen, D. Moher, The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann. Intern. Med. 151, W65–W94 (2009)
    Article PubMed Google Scholar
15. J. Higgins, D.G. Altman, P.C. Gotzsche, P. Jüni, D. Moher, A.D. Oxman, J. Savovic, K.F. Schulz, L. Weeks, J.A. Sterne, The Cochrane collaboration’s tool for assessing risk of bias in randomized trials. BMJ 343, d5928 (2011)
    Article PubMed Central PubMed Google Scholar
16. A.R. Jadad, R.A. Moore, D. Carroll, C. Jenkinson, D.J. Reynolds, D.J. Gavaghan, H.J. McQuay, Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control. Clin. Trials 17, 1–12 (1996)
    Article CAS PubMed Google Scholar
17. J.P.T. Higgins, S. Green (ed.), Cochrane Handbook for Systematic Reviews of Interventions (The Cochrane Collaboration, 5.1.0. Oxford, 2011)
18. J.J.A.D. Deeks, M.J. Bradburn, Statistical methods for examining heterogeneity and combining results from several studies in meta-analysis, in Systematic Reviews in Health Care, ed. by M.D.-S.G. Egger, D.G. Altman (BMJ Publishing, London, 2001), pp. 285–312
    Chapter Google Scholar
19. R. Malek, F. Ajili, S.H. Assaad-Khalil, A. Shinde, J.W. Chen, E. Van den Berg, Similar glucose control with basal-bolus regimen of insulin detemir plus insulin aspart and thrice-daily biphasic insulin aspart 30 in insulin-naive patients with type 2 diabetes: Results of a 50-week randomized clinical trial of stepwise insulin intensification. Diabetes Metab. (2014). doi:10.1016/j.diabet.2014.11.002
    PubMed Google Scholar
20. W. Jia, X. Xiao, Q. Ji, K.-J. Ahn, L.-M. Chuang, Y. Bao, C. Pang, L. Chen, F. Gao, Y. Tu, P. Li, J. Yang, Comparison of thrice-daily premixed insulin (insulin lispro premix) with basal-bolus (insulin glargine once-daily plus thrice-daily prandial insulin lispro) therapy in east Asian patients with type 2 diabetes insufficiently controlled with twice-daily premixed insulin: an open-label, randomised, controlled trial. Lancet Diabetes Endocrinol. 3, 254–262 (2015)
    Article CAS PubMed Google Scholar
21. D. Giugliano, M. Tracz, S. Shah, A. Calle-Pascual, C. Mistodie, R. Duarte, R. Sari, V. Woo, A.O. Jiletcovici, J. Deinhard, S.A. Wille, J. Kiljanski, Initiation and gradual intensification of premixed insulin lispro therapy versus basal ± mealtime insulin in patients with type 2 diabetes eating light breakfasts. Diabetes Care 37, 372–380 (2014)
    Article CAS PubMed Google Scholar
22. F.J. Tinahones, J.L. Gross, A. Onaca, S. Cleall, A. Rodríguez, Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial. Diabetes Obes. Metab. 16, 963–970 (2014)
    Article PubMed Central CAS PubMed Google Scholar
23. M.C. Riddle, J. Rosenstock, A. Vlajnic, L. Gao, Randomized, 1-year comparison of three ways to initiate and advance insulin for type 2 diabetes: twice-daily premixed insulin versus basal insulin with either basal-plus one prandial insulin or basal-bolus up to three prandial injections. Diabetes Obes. Metab. 16, 396–402 (2014)
    Article CAS PubMed Google Scholar
24. K. Bowering, V.A. Reed, J.S. Felicio, J. Landry, L. Ji, J. Oliveira, A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study. Diabet. Med. 29, e263–e272 (2012)
    Article CAS PubMed Google Scholar
25. P.A. Levin, Q. Zhang, J.H. Mersey, F.Y. Lee, L.A: Bromberger, M. Bhushan, R. Bhushan, Glycemic control with insulin glargine plus insulin glulisine versus premixed insulin analogues in real-world practices: a cost-effectiveness study with a randomized pragmatic trial design. Clin. Ther. 33, 841–850 (2011)
    Article CAS PubMed Google Scholar
26. A. Fritsche, M. Larbig, D. Owens, H.U. Häring, GINGER study group, Comparison between a basal-bolus and a premixed insulin regimen in individuals with type 2 diabetes-results of the GINGER study. Diabetes Obes. Metab. 12, 115–123 (2010)
    Article CAS PubMed Google Scholar
27. W.F. Miser, R. Arakaki, H. Jiang, J. Scism-Bacon, P.W. Anderson, J.L. Fahrbach, Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin. Ther. 32, 896–908 (2010)
    Article CAS PubMed Google Scholar
28. S.M. Jain, X. Mao, M. Escalante-Pulido, N. Vorokhobina, I. Lopez, L.L. Ilag, Prandial-basal insulin regimens plus oral antihyperglycaemic agents to improve mealtime glycaemia: initiate and progressively advance insulin therapy in type 2 diabetes. Diabetes Obes. Metab. 12, 967–975 (2010)
    Article PubMed Central CAS PubMed Google Scholar
29. PREFER Study Group, A. Liebl, R. Prager, K. Binz, M. Kaiser, R. Bergenstal, B. Gallwitz, Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes. Metab. 11, 45–52 (2009)
    Article Google Scholar
30. J. Rosenstock, A.J. Ahmann, G. Colon, J. Scism-Bacon, H. Jiang, S. Martin, Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal-bolus (glargine/lispro) therapy. Diabetes Care 31, 20–25 (2008)
    Article CAS PubMed Google Scholar
31. R.J. Ligthelm, U. Mouritzen, H. Lynggaard, M. Landin-Olsson, C. Fox, C. le Devehat, E. Romero, A. Liebl, Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp. Clin. Endocrinol. Diabetes 114, 511–519 (2006)
    Article CAS PubMed Google Scholar
32. European Medicines Agency, Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. CPMP/EWP/1080/00 Rev. 1. 14 May 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129256.pdf. Accessed 27 Apr 2015
33. Food and Drug Administration, Guidance for industry diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. draft guidance (2008). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf. Accessed 17 Apr 2015
34. D. Giugliano, M.I. Maiorino, G. Bellastella, P. Chiodini, A. Ceriello, K. Esposito, Efficacy of insulin analogs in achieving the hemoglobin A1c target of <7 % in type 2 diabetes: meta-analysis of randomized controlled trials. Diabetes Care 34, 510–517 (2011)
    Article PubMed Central CAS PubMed Google Scholar
35. R. Miao, W. Wei, O. Baser, L. Xie, Real world outcomes of adding rapid-acting insulin versus switching to analog premix insulin among US patients with type 2 diabetes treated with insulin glargine. Patient Prefer Adherence 7, 951–960 (2013)
    Article PubMed Central PubMed Google Scholar
36. 4-T Study Group, R.R. Holman, K.I. Thorne, A.J. Farmer, M.J. Davies, J.F. Keenan, S. Paul, J.C. Levy, Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. New Engl. J. Med. 357, 1716–1730 (2007)
    Article Google Scholar
37. 4-T Study Group, R.R. Holman, A.J. Farmer, M.J. Davies, J.C. Levy, J.L. Darbyshire, J.F. Keenan, S.K. Paul, Three-year efficacy of complex insulin regimens in type 2 diabetes. New Engl. J. Med. 361, 1736–1747 (2009)
    Article Google Scholar
38. D. Giugliano, M.I. Maiorino, G. Bellastella, P. Chiodini, K. Esposito, Treatment regimens with insulin analogues and haemoglobin A1c target of <7 % in type 2 diabetes: a systematic review. Diabetes Res. Clin. Pract. 92, 1–10 (2011)
    Article CAS PubMed Google Scholar
39. D. Giugliano, M.I. Maiorino, G. Bellastella, M. Petrizzo, A. Ceriello, S. Genovese, K. Esposito, Setting the hemoglobin A1c target in type 2 diabetes: a priori, a posteriori, or neither? Endocrine (2015). doi:10.1136/bmjopen-2014-005892
    Google Scholar
40. G. Dieuzeide, L.M. Chuang, A. Almaghamsi, A. Zilov, J.W. Chen, F.J. Lavalle-González, Safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes switching from basal-bolus insulin regimens in the A1chieve study. Prim Care Diabetes 8, 111–117 (2014)
    Article PubMed Google Scholar
41. C. Mathieu, F. Storms, J. Tits, T.F. Veneman, I.M. Colin, Switching from premixed insulin to basal-bolus insulin glargine plus rapid-acting insulin: the ATLANTIC study. Acta Clin. Belg. 68, 28–33 (2013)
    Article CAS PubMed Google Scholar
42. H.I. Price, M.D. Agnew, J.-M. Gamble, Comparative cardiovascular morbidity and mortality in patients taking different insulin regimens for type 2 diabetes: a systematic review. BMJ Open 5, e006341 (2015)
    Article PubMed Central PubMed Google Scholar

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