Choice of therapy in patients with type 2 diabetes inadequately controlled with metformin and a sulphonylurea: A systematic review and mixed-treatment comparison meta-analysis

Open Medicine

Volumn 6, Issue 2, 2012, Pages 62-67

  McIntosh, Brendan ^a   Cameron, Chris ^a   Singh, Sumeet R ^a   Yu, Changhua ^a   Dolovich, Lisa ^b   Houlden, Robyn ^c  

^a CANADIAN AGENCY FOR DRUGS AND TECHNOLOGIES IN HEALTH   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

^c QUEEN S UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; METFORMIN; SULFONYLUREA DERIVATIVE;

ARTICLE; BAYES THEOREM; COMPARATIVE EFFECTIVENESS; DRUG COMBINATION; HUMAN; META ANALYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; REGRESSION ANALYSIS; STATISTICAL MODEL; TREATMENT OUTCOME;

BAYES THEOREM; COMPARATIVE EFFECTIVENESS RESEARCH; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; HUMANS; HYPOGLYCEMIC AGENTS; METFORMIN; MODELS, STATISTICAL; REGRESSION ANALYSIS; SULFONYLUREA COMPOUNDS; TREATMENT OUTCOME;

EID: 84864305391     PISSN: None     EISSN: 19112092     Source Type: Journal    
DOI: None     Document Type: Article

References (93)

1. Canadian Diabetes Association. Canadian Diabetes Association 2008 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes 2008;32(Suppl 1) (accessed 2011 Jun 15)
2. National Collaborating Centre for Chronic Conditions. Type 2 diabetes: National clinical guideline for management in primary and secondary care (update). London (UK): Royal College of Physicians; 2008 (accessed 2008 Dec 19)
3. Standards of medical care in diabetes-2009. Diabetes Care 2009;32(Suppl 1):13-61.
4. Government of South Australia, Department of Health. Managing type 2 diabetes in South Australia. Government of South Australia, Department of Healt
5. New Zealand Guidelines Group. Management of type 2 diabetes. Wellington: The Group; 2003 (accessed 2009 Jan 19)
6. IDF clinical guidelines task force. Global guideline for type 2 diabetes. Brussels: International Diabetes Federation; 2005 (accessed 2009 Jan 19)
7. American Diabetes Association. Standards of medical care in diabetes- 2010. Diabetes Care 2010;33(Suppl 1):11-61. (accessed 2010 Jan 21) [Full Text]
8. National Collaborating Centre for Chronic Conditions. Type 2 diabetes: the management of type 2 diabetes. London: National Institute for Health and Clinical Excellence; 2009 NICE clinical guideline 87
9. Canadian Agency for Drugs and Technologies in Health. Optimal therapy recommendations for the prescribing and use of second-line therapy for patients with type 2 diabetes inadequately controlled on metformin. CADTH optimal therapy report 2010;4(5) (accessed 2011 Jun 15) Ottawa: The Agency
10. Colagiuri S, Dickinson S, Girgis S, Colagiuri R. National evidence based guideline for blood glucose control in type 2 diabetes. Canberra: Diabetes Australia and NHMRC; 2009 (accessed 2010 Feb 17)
11. Scotish Intercollegiate Guidelines Network. Management of diabetes: a national clinical guideline. Edinburgh: The Network; 2010 (accessed 2010 Mar 25) Guideline no 116
12. Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA 2010;303(14):1410-1418
13. Canadian Agency for Drugs and Technologies in Health. Second-line therapy for patients with type 2 diabetes inadequately controlled on metformin: a systematic review and cost-effectiveness analysis. Optimal therapy report 2010;4(2)Ottawa: The Agency
14. Canadian Agency for Drugs and Technologies in Health. Current utilization of second- and third-line therapies in patients with type 2 diabetes. Optimal therapy report 2010;4(3) (accessed 2010 Sep 11) Ottawa: The Agency
15. Rodbard HW, Jellinger PS, Davidson JA, Einhorn D, Garber AJ, Grunberger G, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract 2009;15(6):540-559. (2010 Mar 10)
16. Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developers' handbook. Edinburgh: The Network; 2008. Annex C. Methodology checklist 2: randomised controlled trials; p. 52 (accessed 2008 Jun 6)
17. Caldwell DM, Ades AE, Higgins JPT. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ 2005;331(7521):897-900
18. 2007 Mixed treatment comparisons. Bristol (UK): University of Bristol; Dec 20 (accessed 2012 Jan 05)
19. Salanti G. Graphical exploration of incoherence in a network of randomized trials in R [Internet]. Version 2.2. Ioannina (GR): University of Ioannina; 2009 (2012-01-05)
20. Salanti G, Marinho V, Higgins JPT. A case study of multiple-treatments meta-analysis demonstrates that covariates should be considered. J Clin Epidemiol 2009;62(8):857-864
21. Ntzoufras I. Bayesian Modeling Using WinBUGS. Hoboken, NJ, USA: John Wiley & Sons, Inc; 2009
22. Canadian Agency for Drugs and Technologies in Health. CADTH therapeutic review. Ottawa: The Agency; 2010 Clinical review: Third-line therapy for patients with type 2 diabetes inadequately controlled with metformin and sulfonylureas. (accessed 2010 Sep 30)
23. Aljabri K, Kozak SE, Thompson DM. Addition of pioglitazone or bedtime insulin to maximal doses of sulfonylurea and metformin in type 2 diabetes patients with poor glucose control: a prospective, randomized trial. Am J Med 2004;116(4):230-235
24. Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Järvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 2005;28(2):254-259
25. Al-Shaikh AR. Comparison of basal insulin added to oral agents versus twice - daily premixed insulin as initial insulin therapy for type 2 diabetes. Pakistan J Med Sci 2006;22(1):14-17. (accessed 2009 Dec 9)
26. Janka HU, Plewe G, Busch K. Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus. J Am Geriatr Soc 2007;55(2):182-188
27. Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Curr Med Res Opin 2009;25(1):65-75
28. Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 2005;28(5):1083-1091
29. Berhanu P, Perez A, Yu S, Spanheimer R. Effect of pioglitazone in combination with insulin therapy on glycaemic control, insulin dose requirement and lipid profile in patients with type 2 diabetes previously poorly controlled with combination therapy. Diabetes Obes Metab 2007;9(4):512-520
30. Ko GTC, Tsang PCC, Wai HPS, Kan ECY, Chan HCK. Rosiglitazone versus bedtime insulin in the treatment of patients with conventional oral antidiabetic drug failure: A 1-year randomized clinical trial. Adv Ther 2006;23(5):799-808
31. Secnik Boye K, Matza LS, Oglesby A, Malley K, Kim S, Hayes RP, et al. Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes. Health Qual Life Outcomes 2006;4:80. (accessed 2009 May 15)
32. Lam KS, Tiu SC, Tsang MW, Ip TP, Tam SC. Acarbose in NIDDM patients with poor control on conventional oral agents. A 24-week placebo-controlled study. Diabetes Care 1998;21(7):1154-1158. (accessed 2009 Dec 8)
33. Charpentier G, Halimi S. Earlier triple therapy with pioglitazone in patients with type 2 diabetes. Diabetes Obes Metab 2009;11(9):844-854.
34. Lopez-Alvarenga JC, Aguilar-Salinas CA, Velasco-Perez ML, Arita-Melzer O, Guillen LE, Wong B, et al. Acarbose vs. bedtime NPH insulin in the treatment of secondary failures to sulphonylurea-metformin therapy in type 2 diabetes mellitus. Diabetes Obes Metab 1999;1(1):29-35
35. Dailey GE 3rd, Noor MA, Park J, Bruce S, Fiedorek FT. Glycemic control with glyburide/metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: a randomized, double-blind trial. Am J Med 2004;116(4):223-229.
36. Milicevic Z, Hancu N, Car N, Ivanyi T, Schwarzenhofer M, Jermendy G. Effect of two starting insulin regimens in patients with Type II diabetes not controlled on a combination of oral antihyperglycemic medications. Exp Clin Endocrinol Diabetes 2009;117(5):223-229
37. Davies MJ, Thaware PK, Tringham JR, Howe J, Jarvis J, Johnston V, et al. A randomized controlled trial examining combinations of repaglinide, metformin and NPH insulin. Diabet Med 2007;24(7):714-719
38. Nauck MA, Duran S, Kim D, Johns D, Northrup J, Festa A, et al. A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia 2006;50(2):259-267
39. De Mattia G, Laurenti O, Moretti A. Comparison of glycaemic control in patients with Type 2 diabetes on basal insulin and fixed combination oral antidiabetic treatment: results of a pilot study. Acta Diabetol 2008;46(1):67-73
40. Ovalle F, Bell DSH. Effect of rosiglitazone versus insulin on the pancreatic beta-cell function of subjects with type 2 diabetes. Diabetes Care 2004;27(11):2585-2589.
41. Derosa G, Salvadeo SAT, D'Angelo A, Ferrari I, Mereu R, Palumbo I, et al. Metabolic effect of repaglinide or acarbose when added to a double oral antidiabetic treatment with sulphonylureas and metformin: a double-blind, cross-over, clinical trial. Curr Med Res Opin 2009;25(3):607-615
42. Reynolds LR, Kingsley FJ, Karounos DG, Tannock LR. Differential effects of rosiglitazone and insulin glargine on inflammatory markers, glycemic control, and lipids in type 2 diabetes. Diabetes Res Clin Pract 2007;77(2):180-187
43. Dorkhan M, Dencker M, Stagmo M, Groop L. Effect of pioglitazone versus insulin glargine on cardiac size, function, and measures of fluid retention in patients with type 2 diabetes. Cardiovasc Diabetol 2009;8(15):15. (accessed 2009 Dec 4)
44. Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G. Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care 2006;29(3):554-559. (accessed 2009 Dec 4)
45. Esposito K, Ciotola M, Maiorino MI, Gualdiero R, Schisano B, Ceriello A, et al. Addition of neutral protamine lispro insulin or insulin glargine to oral type 2 diabetes regimens for patients with suboptimal glycemic control: a randomized trial. Ann Intern Med 2008;149(8):531-539
46. Ross SA, Zinman B, Campos RV, Strack T. A comparative study of insulin lispro and human regular insulin in patients with type 2 diabetes mellitus and secondary failure of oral hypoglycemic agents. Clin Invest Med 2001;24(6):292-298
47. Gao Y, Yoon KH, Chuang L, Mohan V, Ning G, Shah S, et al. Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea. Diabetes Res Clin Pract 2009;83(1):69-76
48. Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia 2009;52(10):2046-2055
49. Goudswaard AN, Stolk RP, Zuithoff P, de Valk HW, Rutten GE. Starting insulin in type 2 diabetes: continue oral hypoglycemic agents? A randomized trial in primary care. J Fam Pract 2004;53(5):393-399. (2009-12-04)
50. Standl E, Schernthaner G, Rybka J, Hanefeld M, Raptis SA, Naditch L. Improved glycaemic control with miglitol in inadequately-controlled type 2 diabetics. Diabetes Res Clin Pract 2001;51(3):205-213
51. Hartemann-Heurtier A, Halbron M, Golmard J, Jacqueminet S, Bastard J, Rouault C, et al. Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes. Diabetes Res Clin Pract 2009;86(1):37-43
52. Stehouwer MH, DeVries JH, Lumeij JA, Adèr HJ, Engbers AM, Iperen A. Combined bedtime insulin-daytime sulphonylurea regimen compared with two different daily insulin regimens in type 2 diabetes: effects on HbA1c and hypoglycaemia rate-a randomised trial. Diabetes Metab Res Rev 2003;19(2):148-152.
53. Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med 2005;143(8):559-569. (accessed 2009 Dec 3)
54. Strojek K, Bebakar WMW, Khutsoane DT, Pesic M, Šmahelová A, Thomsen HF, et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin 2009;25(12):2887-2894
55. Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab 2007;9(5):733-745
56. Vinik AI, Zhang Q. Adding insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diabetes Care 2007;30(4):795-800
57. Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007;357(17):1716-1730. (2009-12-03)
58. Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, Vähätalo M, Virtamo H, Nikkilä K, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006;49(3):442-451
59. Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med 2009;361(18):1736-1747. [CrossRef] [PubMed]
60. Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009;373(9681):2125-2135
61. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356(24):2457-2471
62. Canadian Agency for Drugs and Technologies in Health. Current practice analysis of health care providers and patients: second-line therapy for patients with type 2 diabetes inadequately controlled on metformin. Optimal therapy report 2010;4(4) (accessed 2010 Jun 29) Ottawa: The Agency
63. Canadian Agency for Drugs and Technologies in Health. Current practice analysis: insulin analogues. A qualitative analysis of Canadian physician perceptions and use of insulin analogues. Optimal therapy report 2008;2(6) (accessed 2008 Apr 11) Ottawa: The Agency
64. Agarwal G, Nair K, Cosby J, Dolovich L, Levine M, Kaczorowski J, et al. GPs' approach to insulin prescribing in older patients: a qualitative study. Br J Gen Pract 2008;58(553):569-575
65. Bolen S, Feldman L, Vassy J, Wilson L, Yeh H, Marinopoulos S, et al. Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med 2007;147(6):386-399. (accessed 2010 May 14)
66. Cardiovascular outcomes in trials of oral diabetes medications: a systematic review
67. U.S. Food and Drug Administration. FDA drug safety communication: update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer. Silver Spring (MD): The Administration; 2011 (accessed 2011 Aug 11)
68. Pocock N. NeLM news service: Germany joins France in suspending use of pioglitazone while EMA safety review is ongoing (summary). London: National electronic Library for Medicines; 2011 (accessed 2011 Aug 11)
69. MedWatch the FDA safety information and adverse event reporting program: safety information. Silver Spring (MD): US Food and Drug Administration; 2007 Byetta (exenatide). (accessed 2009 Oct 8)
70. Dore DD, Seeger JD, Chan KA. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin 2009;25(4):1019-1027
71. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352(9131):837-853
72. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359(15):1577-1589
73. Gerstein HC, Miller ME, Byington RP, Goff DC. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358(24):2545-2559
74. Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;2008(358):2560-2572
75. Turnbull FM, Abraira C, Anderson RJ, Byington RP, Chalmers JP, Duckworth WC, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia 2009;52(11):2288-2298
76. Ray KK, Seshasai SRK, Wijesuriya S, Sivakumaran R, Nethercott S, Preiss D, et al. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. Lancet 2009;373(9677):1765-1772
77. Currie CJ, Peters JR, Tynan A, Evans M, Heine RJ, Bracco OL, et al. Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study. Lancet 2010;375(9713):481-489
78. Gross JL, Kramer CK, Leitão CB, Hawkins N, Viana LV, Schaan BD, et al. Effect of antihyperglycemic agents added to metformin and a sulfonylurea on glycemic control and weight gain in type 2 diabetes: a network meta-analysis. Ann Intern Med 2011;154(10):672-679
79. Perfetti R, Merkel P. Glucagon-like peptide-1: a major regulator of pancreatic beta-cell function. Eur J Endocrinol 2000;143(6):717-725
80. Yeom J, Kim ES, Park H, Ham D, Sun C, Kim J, et al. Both sitagliptin analogue & pioglitazone preserve the Beta-cell proportion in the islets with different mechanism in non-obese and obese diabetic mice. BMB Rep 2011;44(11):713-718
81. Kanda Y, Shimoda M, Hamamoto S, Tawaramoto K, Kawasaki F, Hashiramoto M, et al. Molecular mechanism by which pioglitazone preserves pancreatic beta-cells in obese diabetic mice: evidence for acute and chronic actions as a PPARgamma agonist. Am J Physiol Endocrinol Metab 2009;298(2)
82. Richter B, Bandeira-Echtler E, Bergerhoff K, Lerch CL. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus. Cochrane Database Syst Rev 2008;2(2)
83. Shyangdan DS, Royle PL, Clar C, Sharma P, Waugh NR. Glucagon-like peptide analogues for type 2 diabetes mellitus: systematic review and meta-analysis. BMC Endocr Disord 2010;10(1):20. (2011-08-11)
84. Nakamura T, Funahashi T, Yamashita S, Nishida M, Nishida Y, Takahashi M, et al. Thiazolidinedione derivative improves fat distribution and multiple risk factors in subjects with visceral fat accumulation-double-blind placebo-controlled trial. Diabetes Res Clin Pract 2001;54(3):181-190
85. Nesto RW, Bell D, Bonow RO, Fonseca V, Grundy SM, Horton ES, et al. Thiazolidinedione use, fluid retention, and congestive heart failure: a consensus statement from the American Heart Association and American Diabetes Association. October 7, 2003. Circulation 2003;108(23):2941-2948. (accessed 2007 Nov 20)
86. Fonseca V. Effect of thiazolidinediones on body weight in patients with diabetes mellitus. Am J Med 2003;115(Suppl 8A):42-48
87. Wajchenberg BL. Subcutaneous and visceral adipose tissue: their relation to the metabolic syndrome. Endocr Rev 2000;21(6):697-738
88. WHO Consultation on Obesity (1999: Geneva, Switzerland). Obesity: preventing and managing the global epidemic: report of a WHO consultation. (WHO technical report series; 894). Geneva: World Health Organization (WHO); 2000 (accessed 2009 Nov 29)
89. Wing RR, Koeske R, Epstein LH, Nowalk MP, Gooding W, Becker D. Long-term effects of modest weight loss in type II diabetic patients. Arch Intern Med 1987;147(10):1749-1753
90. Fujioka K, Seaton TB, Rowe E, Jelinek CA, Raskin P, Lebovitz HE, et al. Weight loss with sibutramine improves glycaemic control and other metabolic parameters in obese patients with type 2 diabetes mellitus. Diabetes Obes Metab 2000;2(3):175-187
91. Amiel SA, Dixon T, Mann R, Jameson K. Hypoglycaemia in Type 2 diabetes. Diabet Med 2008;25(3):245-254. (2010-01-22)
92. Edwards KL, Alvarez C, Irons BK, Fields J. Third-line agent selection for patients with type 2 diabetes mellitus uncontrolled with sulfonylureas and metformin. Pharmacotherapy 2008;28(4):506-521
93. Black C, Donnelly P, McIntyre L, Royle PL, Shepherd JP, Thomas S. Meglitinide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007;2(2)