The cost-effectiveness and budget impact of stepwise addition of bolus insulin in the treatment of type 2 diabetes: evaluation of the FullSTEP trial

References

• Prevention. CfDCa. National Diabetes Statistics Report: estimates of diabetes and its burden in the United States, 2014. In: Prevention. CfDCa, ed. Atlanta, GA: US Department of Health and Human Services, 2014
   Google Scholar
• International Diabetes Federation. IDF Diabetes Atlas. Brussels, Belgium: International Diabetes Federation, 2013
   Google Scholar
• Association AD. Economic costs of diabetes in the U.S. in 2012. Diabetes Care 2013;36:1033–46
   Google Scholar
• Jonsson B. Revealing the cost of Type II diabetes in Europe. Diabetologia 2002;45:S5–12
   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;321:405–12
   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;35:1364–79
   PubMed Web of Science ®Google Scholar
• Meneghini LF. Early insulin treatment in type 2 diabetes: what are the pros? Diabetes Care 2009;32(2 Suppl):S266–9
   Google Scholar
• Viana LV, Leitao CB, Grillo Mde F, et al. Are diabetes management guidelines applicable in ‘real life’? Diabetol Metabc Syndr 2012;4:47
   Google Scholar
• Hollander P, Cooper J, Bregnhoj J, et al. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Therapeut 2008;30:1976–87
   PubMed Web of Science ®Google Scholar
• Donnelly LA, Morris AD, Evans JM, et al. Adherence to insulin and its association with glycaemic control in patients with type 2 diabetes. QJM: Monthly Journal of the Association of Physicians 2007;100:345–50
   PubMed Web of Science ®Google Scholar
• Peyrot M, Barnett AH, Meneghini LF, et al. Factors associated with injection omission/non-adherence in the Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabetes Obes Metab 2012;14:1081–7
   PubMed Web of Science ®Google Scholar
• Ross SA, Tildesley HD, Ashkenas J. Barriers to effective insulin treatment: the persistence of poor glycemic control in type 2 diabetes. Curr Med Res Opin 2011;27(3 Suppl):13–20
   Google Scholar
• Evans M, Wolden M, Gundgaard J, et al. Cost-effectiveness of insulin degludec compared with insulin glargine for patients with type 2 diabetes treated with basal insulin - from the UK health care cost perspective. Diabetes Obes Metab 2014;16:366–75
   PubMed Web of Science ®Google Scholar
• Brandle M, Azoulay M, Greiner RA. Cost-effectiveness of insulin glargine versus NPH insulin for the treatment of Type 2 diabetes mellitus, modeling the interaction between hypoglycemia and glycemic control in Switzerland. Int J Clin Pharmacol Therapeut 2011;49:217–30
   PubMed Web of Science ®Google Scholar
• Ridderstrale M, Jensen MM, Gjesing RP, et al. Cost-effectiveness of insulin detemir compared with NPH insulin in people with type 2 diabetes in Denmark, Finland, Norway, and Sweden. J Med Econ 2013;16:468–78
   Google Scholar
• Edelman S, Dailey G, Flood T, et al. A practical approach for implementation of a basal-prandial insulin therapy regimen in patients with type 2 diabetes. Osteopath Med Prim Care 2007;1:9
   Google Scholar
• Riddle MC, Rosenstock J, Vlajnic A, et al. 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 2014;16:396–402
   PubMedGoogle Scholar
• Rodbard HW, Visco VE, Andersen H, et al. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol 2014;2:30–7
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011
   Google Scholar
• Blak BT, Smith HT, Hards M, et al. Optimization of insulin therapy in patients with type 2 diabetes mellitus: beyond basal insulin. Diabetic Med J Br Diabetic Assoc 2012;29:e13–20
   PubMed Web of Science ®Google Scholar
• Swinnen SG, Simon AC, Holleman F, et al. Insulin detemir versus insulin glargine for type 2 diabetes mellitus. Cochrane Database System Rev 2011;(7):CD006383
   Google Scholar
• Pollack M, Waterman F, Bolge SC, et al. Satisfaction with diabetes treatments: impacts on patient health-related quality of life and productivity. ISPOR 14th Annual International Meeting Orlando, FL, US; 2009. PDB45
   Google Scholar
• Evans M, Jensen HH, Bogelund M, et al. Flexible insulin dosing improves health-related quality-of-life (HRQoL): a time trade-off survey. J Med Econ 2013;16:1357–65
   PubMedGoogle Scholar
• National Institute for Health and Care Excellence. Dapagliflozin in combination therapy for treating type 2 diabetes. NICE Technology Appraisal Guidance 2013 . Available at http://www.nice.org.uk/guidance/ta288/chapter/3-The-manufacturers-submission
   Google Scholar
• Pieper L, Klotsche J, Pittrow D, et al. Health-related quality of life of type 2 diabetics in German primary care: results of the DETECT study. ISPOR 9th Annual European Congress. Copenhagen, Denmark; 2006
   Google Scholar
• Evans M, Khunti K, Mamdani M, et al. Health-related quality of life associated with daytime and nocturnal hypoglycaemic events: a time trade-off survey in five countries. Health Qual Life Outcomes 2013;11:90
   PubMed Web of Science ®Google Scholar
• Hammer M, Lammert M, Mejias SM, et al. Costs of managing severe hypoglycaemia in three European countries. J Med Econ 2009;12:281–90
   PubMedGoogle Scholar
• Jonsson L, Bolinder B, Lundkvist J. Cost of hypoglycemia in patients with Type 2 diabetes in Sweden. Value Health J Int Soc Pharmacoecon Outcomes Res 2006;9:193–8
   Google Scholar
• Levy AR, Christensen TL, Johnson JA. Utility values for symptomatic non-severe hypoglycaemia elicited from persons with and without diabetes in Canada and the United Kingdom. Health Qual Life Outcomes 2008;6:73
   PubMed Web of Science ®Google Scholar
• Harris S, Mamdani M, Galbo-Jorgensen CB, et al. The effect of hypoglycemia on health-related quality of life: Canadian results from a multinational time trade-off survey. Can J diabetes 2014;38:45–52
   PubMed Web of Science ®Google Scholar
• Guillermin AL, Samyshkin Y, Wright D, et al. Modeling the lifetime costs of insulin glargine and insulin detemir in type 1 and type 2 diabetes patients in Canada: a meta-analysis and a cost-minimization analysis. J Med Econ 2011;14:207–16
   PubMedGoogle Scholar
• Palmer JL, Goodall G, Nielsen S, et al. Cost-effectiveness of insulin aspart versus human soluble insulin in type 2 diabetes in four European countries: subgroup analyses from the PREDICTIVE study. Curr Med Res Opin 2008;24:1417–28
   PubMed Web of Science ®Google Scholar
• Samyshkin Y, Guillermin AL, Best JH, et al. Long-term cost-utility analysis of exenatide once weekly versus insulin glargine for the treatment of type 2 diabetes patients in the US. J Med Econ 2012;15(2 Suppl):6–13
   PubMedGoogle Scholar
• Brod M, Christensen T, Thomsen TL, et al. The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health J Int Soc Pharmacoecon Outcomes Res 2011;14:665–71
   Google Scholar
• Quilliam BJ, Simeone JC, Ozbay AB, et al. The incidence and costs of hypoglycemia in type 2 diabetes. Am J Manag Care 2011;17:673–80
   PubMed Web of Science ®Google Scholar
• Holman RR, Thorne KI, Farmer AJ, et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007;357:1716–30
   PubMed Web of Science ®Google Scholar
• Miser WF, Arakaki R, Jiang H, et al. 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 Therapeut 2010;32:896–908
   PubMed Web of Science ®Google Scholar