Long-term studies of treatments for type 2 diabetes

References

• International Diabetes Federation. International Diabetes Federation Atlas Sixth Edition. 2014 [cited 2016 Sep 12]. Available from: http://www.idf.org/diabetesatlas
   Google Scholar
• Defronzo RA. Banting lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58:773–795.
   PubMed Web of Science ®Google Scholar
• Inzucchi SE, Bergenstal RM, Buse JB, et al. 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. 2012;35:1364–1379.
   PubMed Web of Science ®Google Scholar
• Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405–412.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care. 2014;37(Suppl 1):S14–S80.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Standards of medical care in diabetes—2015. Diabetes Care. 2015;38(Suppl 1):S1–S94.
   Google Scholar
• Kirkman MS, McCarren M, Shah J, et al. The association between metabolic control and prevalent macrovascular disease in type 2 diabetes: the VA Cooperative Study in diabetes. J Diabetes Complications. 2006;20:75–80.
   PubMed Web of Science ®Google Scholar
• Friedewald WT, Buse JB, Bigger JT, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545–2559.
   PubMed Web of Science ®Google Scholar
• BARI 2D Study Group, Frye RL, August P, et al. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009;360:2503–2515.
   PubMed Web of Science ®Google Scholar
• ADVANCE Collaborative Group, Patel A, MacMahon S, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560–2572.
   PubMed Web of Science ®Google Scholar
• Zoungas S, Chalmers J, Kengne AP, et al. The efficacy of lowering glycated haemoglobin with a gliclazide modified release-based intensive glucose lowering regimen in the ADVANCE trial. Diabetes Res Clin Pract. 2010;89:126–133.
   PubMed Web of Science ®Google Scholar
• Buse JB, Bigger JT, Byington RP, et al. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol. 2007;99:21i–33i.
   PubMed Web of Science ®Google Scholar
• UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). [Erratum appears in Lancet 1999 Aug 14;354(9178):602]. Lancet. 1998;352:837–853.
   PubMed Web of Science ®Google Scholar
• Konig M, Lamos EM, Stein SA, et al. An insight into the recent diabetes trials: what is the best approach to prevent macrovascular and microvascular complications? Curr Diabetes Rev. 2013;9:371–381.
   PubMedGoogle Scholar
• Wilcox R, Kupfer S, Erdmann E, et al. Effects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10).[Erratum appears in Am Heart J. 2008 Aug;156(2):255]. Am Heart J. 2008;155:712–717.
   PubMed Web of Science ®Google Scholar
• Hong J, Zhang Y, Lai S, et al. Effects of metformin versus glipizide on cardiovascular outcomes in patients with type 2 diabetes and coronary artery disease. Diabetes Care. 2013;36:1304–1311.
   PubMed Web of Science ®Google Scholar
• Kooy A, De Jager J, Lehert P, et al. Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus. Arch Intern Med. 2009;169:616–625.
   PubMed Web of Science ®Google Scholar
• De Jager J, Kooy A, Schalkwijk C, et al. Long-term effects of metformin on endothelial function in type 2 diabetes: a randomized controlled trial. J Intern Med. 2014;275:59–70.
   PubMed Web of Science ®Google Scholar
• Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355:2427–2443.
   PubMed Web of Science ®Google Scholar
• Kahn SE, Lachin JM, Zinman B, et al. Effects of rosiglitazone, glyburide, and metformin on beta-cell function and insulin sensitivity in ADOPT. Diabetes. 2011;60:1552–1560.
   PubMed Web of Science ®Google Scholar
• Lachin JM, Viberti G, Zinman B, et al. Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapy. Clin J Am Soc Nephrol. 2011;6:1032–1040.
   PubMed Web of Science ®Google Scholar
• Komajda M, McMurray JJV, Beck-Nielsen H, et al. Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial. Eur Heart J. 2010;31:824–831.
   PubMed Web of Science ®Google Scholar
• Jones NP, Curtis PS, Home PD. Cancer and bone fractures in observational follow-up of the RECORD study. Acta Diabetol. 2015;52:539–546.
   PubMed Web of Science ®Google Scholar
• Bach RG, Brooks MM, Lombardero M, et al. Rosiglitazone and outcomes for patients with diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Circulation. 2013;128:785–794.
   PubMed Web of Science ®Google Scholar
• Tolman KG, Freston JW, Kupfer S, et al. Liver safety in patients with type 2 diabetes treated with pioglitazone: results from a 3-year, randomized, comparator-controlled study in the US. Drug Saf. 2009;32:787–800.
   PubMed Web of Science ®Google Scholar
• Erdmann E, Song E, Spanheimer R, et al. Observational follow-up of the PROactive study: a 6-year update. Diabetes Obes Metab. 2014;16:63–74.
   PubMed Web of Science ®Google Scholar
• Charbonnel B, DeFronzo R, Davidson J, et al. Pioglitazone use in combination with insulin in the prospective pioglitazone clinical trial in macrovascular events study (PROactive19). J Clin Endocrinol Metab. 2010;95:2163–2171.
   PubMed Web of Science ®Google Scholar
• Erdmann E, Harding S, Lam H, et al. Ten-year observational follow-up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes. Diabetes Obes Metab. 2016;18:266–273.
   PubMed Web of Science ®Google Scholar
• Kaku K, Daida H, Kashiwagi A, et al. Long-term effects of pioglitazone in Japanese patients with type 2 diabetes without a recent history of macrovascular morbidity. Curr Med Res Opin. 2009;25:2925–2932.
   PubMed Web of Science ®Google Scholar
• Yamasaki Y, Katakami N, Furukado S, et al. Long-term effects of pioglitazone on carotid atherosclerosis in Japanese patients with type 2 diabetes without a recent history of macrovascular morbidity. J Atheroscler Thromb. 2010;17:1132–1140.
   PubMed Web of Science ®Google Scholar
• Stringer F, DeJongh J, Enya K, et al. Evaluation of the long-term durability and glycemic control of fasting plasma glucose and glycosylated hemoglobin for pioglitazone in Japanese patients with type 2 diabetes. Diabetes Technol Ther. 2015;17:215–223.
   PubMed Web of Science ®Google Scholar
• Gerstein HC, Bosch J, Dagenais GR, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012;367:319–328.
   PubMed Web of Science ®Google Scholar
• Punthakee Z, Gerstein HC, Bosch J, et al. Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE). Diabetes Care. 2016;39:709–716.
   PubMed Web of Science ®Google Scholar
• Li JL, Feng ZP, Li QF, et al. Insulin glargine effectively achieves glycemic control and improves insulin resistance in patients with early type 2 diabetes that exhibit a high risk for cardiovascular disease. Exp Ther Med. 2014;8:147–152.
   PubMed Web of Science ®Google Scholar
• Kacerovsky-Bielesz G, Dressler A, Freunscht R. Long-term glycaemic control with insulin glargine in type 2 diabetes. Diabetes Res Clin Pract. 2006;71:184–191.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Fonseca V, McGill JB, et al. Similar progression of diabetic retinopathy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: a long-term, randomised, open-label study. Diabetologia. 2009;52:1778–1788.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Fonseca V, Schinzel S, et al. Reduced risk of hypoglycemia with once-daily glargine versus twice-daily NPH and number needed to harm with NPH to demonstrate the risk of one additional hypoglycemic event in type 2 diabetes: evidence from a long-term controlled trial. J Diabetes Complications. 2014;28:742–749.
   PubMed Web of Science ®Google Scholar
• Birkeland KI, Rishaug U, Hanssen KF, et al. NIDDM: a rapid progressive disease. Results from a long-term, randomised, comparative study of insulin or sulphonylurea treatment. Diabetologia. 1996;39:1629–1633.
   PubMed Web of Science ®Google Scholar
• Alvarsson M, Sundkvist G, Lager I, et al. Effects of insulin vs. glibenclamide in recently diagnosed patients with type 2 diabetes: a 4-year follow-up. Diabetes Obes Metab. 2008;10:421–429.
   PubMed Web of Science ®Google Scholar
• Harrison LB, Adams-Huet B, Raskin P, et al. β-cell function preservation after 3.5 years of intensive diabetes therapy. Diabetes Care. 2012;35:1406–1412.
   PubMed Web of Science ®Google Scholar
• Harrison LB, Adams-Huet B, Li X, et al. Intensive therapy in newly diagnosed type 2 diabetes: results of a 6-year randomized trial. J Investig Med. 2014;62:676–686.
   PubMed Web of Science ®Google Scholar
• Labrousse-Lhermine F, Cazals L, Ruidavets JB, et al. Long-term treatment combining continuous subcutaneous insulin infusion with oral hypoglycaemic agents is effective in type 2 diabetes. Diabetes Metab. 2007;33:253–260.
   PubMed Web of Science ®Google Scholar
• Ritsinger V, Malmberg K, Martensson A, et al. Intensified insulin-based glycaemic control after myocardial infarction: mortality during 20 year follow-up of the randomised Diabetes Mellitus Insulin Glucose Infusion in Acute Myocardial Infarction (DIGAMI 1) trial. Lancet Diabetes Endocrinol. 2014;2:627–633.
   PubMed Web of Science ®Google Scholar
• Holman RR, Cull CA, Turner RC. A randomized double-blind trial of acarbose in type 2 diabetes shows improved glycemic control over 3 years (U.K. Prospective Diabetes Study 44).[Erratum appears in Diabetes Care 1999 Nov;22(11):1922]. Diabetes Care. 1999;22:960–964.
   PubMed Web of Science ®Google Scholar
• Kirkman MS, Shankar RR, Shankar S, et al. Treating postprandial hyperglycemia does not appear to delay progression of early type 2 diabetes: the Early Diabetes Intervention Program. Diabetes Care. 2006;29:2095–2101.
   PubMed Web of Science ®Google Scholar
• Matsumoto K, Sera Y, Abe Y, et al. Combination therapy of alpha-glucosidase inhibitor and a sulfonylurea compound prolongs the duration of good glycemic control. Metabolism. 2002;51:1548–1552.
   PubMed Web of Science ®Google Scholar
• Klonoff DC, Buse JB, Nielsen LL, et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008;24:275–286.
   PubMed Web of Science ®Google Scholar
• Bunck MC, Corner A, Eliasson B, et al. Effects of exenatide on measures of beta-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011;34:2041–2047.
   PubMed Web of Science ®Google Scholar
• van Raalte DH, Bunck MC, Smits MM, et al. Exenatide improves beta-cell function up to 3 years of treatment in patients with type 2 diabetes: a randomised controlled trial. Eur J Endocrinol. 2016;175:345–352.
   PubMed Web of Science ®Google Scholar
• Gallwitz B, Guzman J, Dotta F, et al. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial. Lancet. 2012;379:2270–2278.
   PubMed Web of Science ®Google Scholar
• Simó R, Guerci B, Schernthaner G, et al. Long-term changes in cardiovascular risk markers during administration of exenatide twice daily or glimepiride: results from the European exenatide study. Cardiovasc Diabetol. 2015;14:116.
   PubMed Web of Science ®Google Scholar
• Diamant M, Van Gaal L, Guerci B, et al. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014;2:464–473.
   PubMed Web of Science ®Google Scholar
• MacConell L, Pencek R, Li Y, et al. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31–41.
   PubMedGoogle Scholar
• Wysham CH, MacConell LA, Maggs DG, et al. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015;90:356–365.
   PubMed Web of Science ®Google Scholar
• Henry RR, Klein EJ, Han J, et al. Efficacy and tolerability of exenatide once weekly over 6 years in patients with type 2 diabetes: an uncontrolled open-label extension of the DURATION-1 study. Diabetes Technol Ther. 2016;18:677–686.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Gross JL, Aguilar-Salinas C, et al. Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with type 2 diabetes. Diabet Med. 2013;30:1472–1476.
   PubMed Web of Science ®Google Scholar
• Green JB, Bethel MA, Armstrong PW, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;373:232–242.
   PubMed Web of Science ®Google Scholar
• Viberti G, Kahn SE, Greene DA, et al. A diabetes outcome progression trial (ADOPT): an international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care. 2002;25:1737–1743.
   PubMed Web of Science ®Google Scholar
• Home PD, Pocock SJ, Beck-Nielsen H, 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;373:2125–2135.
   PubMed Web of Science ®Google Scholar
• Dormandy JA, Charbonnel B, Eckland DJA, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366:1279–1289.
   PubMed Web of Science ®Google Scholar
• Scheen AJ, Tan MH, Betteridge DJ, et al. Long-term glycaemic effects of pioglitazone compared with placebo as add-on treatment to metformin or sulphonylurea monotherapy in PROactive (PROactive 18). Diabet Med. 2009;26:1242–1249.
   PubMed Web of Science ®Google Scholar
• Hanefeld M, Bramlage P. Insulin use early in the course of type 2 diabetes mellitus: the ORIGIN trial. Curr Diabetes Rep. 2013;13:342–349.
   PubMed Web of Science ®Google Scholar
• ORIGIN Trial Investigators. Predictors of nonsevere and severe hypoglycemia during glucose-lowering treatment with insulin glargine or standard drugs in the ORIGIN trial. Diabetes Care. 2015;38:22–28.
   PubMed Web of Science ®Google Scholar
• Alvarsson M, Berntorp K, Fernqvist-Forbes E, et al. Effects of insulin versus sulphonylurea on beta-cell secretion in recently diagnosed type 2 diabetes patients: a 6-year follow-up study. Rev Diabet Stud. 2010;7:225–232.
   PubMedGoogle Scholar
• Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006;368:1696–1705.
   PubMed Web of Science ®Google Scholar
• Bunck MC, Diamant M, Corner A, et al. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2009;32:762–768.
   PubMed Web of Science ®Google Scholar
• Drucker DJ, Buse JB, Taylor K, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008;372:1240–1250.
   PubMed Web of Science ®Google Scholar
• Turner RC, Cull CA, Frighi V, et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999;281:2005–2012.
   PubMed Web of Science ®Google Scholar
• Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117–2128.
   PubMed Web of Science ®Google Scholar