Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes

References

• UK Prospective Diabetes Study Group. U.K. Prospective Diabetes Study 16: overview of 6 years’ therapy of type II diabetes: a progressive disease. Diabetes. 1995;44:1249–1258.
   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
• American Diabetes Association. Standards of medical care in diabetes—2016. Glycemic Targets Diabetes Care. 2016;39(Suppl 1):S39–S46.
   PubMed Web of Science ®Google Scholar
• Stark Casagrande S, Fradkin JE, Saydah SH, et al. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010. Diabetes Care. 2013;36:2271–2279.
   PubMed Web of Science ®Google Scholar
• Hayes RP, Fitzgerald JT, Jacober SJ. Primary care physician beliefs about insulin initiation in patients with type 2 diabetes. Int J Clin Pract. 2008;62:860–868.
   PubMed Web of Science ®Google Scholar
• Polonsky WH, Fisher L, Guzman S, et al. Psychological insulin resistance in patients with type 2 diabetes: the scope of the problem. Diabetes Care. 2005;28:2543–2545.
   PubMed Web of Science ®Google Scholar
• Polinski JM, Smith BF, Curtis BH, et al. Barriers to insulin progression among patients with type 2 diabetes: a systematic review. Diabetes Educ. 2013;39:53–65.
   PubMed Web of Science ®Google Scholar
• Becker RH, Nowotny I, Teichert L, et al. Low within- and between-day variability in exposure to new insulin glargine 300 U/ml. Diabetes Obes Metab. 2015;17:261–267.
   PubMed Web of Science ®Google Scholar
• Becker RH, Dahmen R, Bergmann K, et al. New insulin glargine 300 units·mL−1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units·mL−1. Diabetes Care. 2015;38:637–643.
   PubMed Web of Science ®Google Scholar
• Shiramoto M, Eto T, Irie S, et al. Single-dose new insulin glargine 300 U/ml provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes. Diabetes Obes Metab. 2015;17:254–260.
   PubMed Web of Science ®Google Scholar
• Bolli GB, Riddle MC, Bergenstal RM, et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015;17:386–394.
   PubMed Web of Science ®Google Scholar
• Riddle MC, Bolli GB, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014;37:2755–2762.
   PubMed Web of Science ®Google Scholar
• Yki-Järvinen H, Bergenstal R, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014;37:3235–3243.
   PubMed Web of Science ®Google Scholar
• Home PD, Bergenstal RM, Bolli GB, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care. 2015;38:2217–2225.
   PubMed Web of Science ®Google Scholar
• Riddle MC, Yki-Järvinen H, Bolli GB, et al. One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension. Diabetes Obes Metab. 2015;17:835–842.
   PubMed Web of Science ®Google Scholar
• Yki-Järvinen H, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015;17:1142–1149.
   PubMed Web of Science ®Google Scholar
• Ritzel R, Roussel R, Bolli GB, et al. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes. Diabetes Obes Metab. 2015;17(9):859–867.
   PubMed Web of Science ®Google Scholar
• Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply? Lancet. 2005;365:82–93.
   PubMed Web of Science ®Google Scholar
• Gandhi GY, Murad MH, Fujiyoshi A, et al. Patient-important outcomes in registered diabetes trials. JAMA. 2008;299:2543–2549.
   PubMed Web of Science ®Google Scholar
• Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342:1887–1892.
   PubMed Web of Science ®Google Scholar
• Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13:217–224.
   PubMedGoogle Scholar
• Lakey WC, Barnard K, Batch BC, et al. Are current clinical trials in diabetes addressing important issues in diabetes care? Diabetologia. 2013;56:1226–1235.
   PubMed Web of Science ®Google Scholar
• Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chron Dis. 1967;20:637–648.
   PubMedGoogle Scholar
• Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009;62:464–475.
   PubMed Web of Science ®Google Scholar
• Oster G, Borok GM, Menzin J, et al. A randomized trial to assess effectiveness and cost in clinical practice: rationale and design of the Cholesterol Reduction Intervention study (CRIS). Control Clin Trials. 1995;16:3–16.
   PubMedGoogle Scholar
• Levin PA, Zhang Q, Mersey JH, et al. 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. 2011;33:841–850.
   PubMed Web of Science ®Google Scholar
• Kauf TL, McKinnon P, Corey GR, et al. An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection. BMC Infect Dis. 2015;15:503.
   PubMed Web of Science ®Google Scholar
• NIH Health Care Systems (HCS) Research Collaboratory [Internet]. Bethesda (MD): National Institutes of Health; [ cited 2012 Jan 24]. Available from: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-12-002.html
   Google Scholar
• Lieu TA, Au D, Krishnan JA, et al. Comparative effectiveness research in lung diseases and sleep disorders: recommendations from the National Heart, Lung, and Blood Institute workshop. Am J Resp Crit Care Med. 2011;184:848–856.
   PubMed Web of Science ®Google Scholar
• Shrank W. The Center For Medicare And Medicaid Innovation’s blueprint for rapid-cycle evaluation of new care and payment models. Health Aff. 2013;32:807–812.
   Web of Science ®Google Scholar
• AHRQ: comparative effectiveness research portfolio [Internet]. Rockville (MD): Agency for Healthcare Research and Quality; [ reviewed 2012 Oct]. Available from: http://www.ahrq.gov/cpi/portfolios/comparative-effectiveness/index.html
   Google Scholar
• PCORI: research we support [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute; [updated 2015 Oct 20; cited 2014 Sep 10]. Available from: http://www.pcori.org/research-results/research-we-support
   Google Scholar
• Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff. 2008;27:759–769.
   PubMed Web of Science ®Google Scholar
• NCQA: HEDIS summary table of measures, product lines and changes [Internet]. Washington (DC): National Committee for Quality Assurance; 2015. [cited 2015 July]. Available from: http://www.ncqa.org/Portals/0/HEDISQM/Hedis2015/List_of_HEDIS_2015_Measures.pdf
   Google Scholar
• Baser O, Bouchard J, DeLuzio T, et al. Assessment of adherence and healthcare costs of insulin device (FlexPen®) versus conventional vial/syringe. Adv Ther. 2010;27:94–104.
   PubMed Web of Science ®Google Scholar
• Bradley C. Diabetes treatment satisfaction questionnaire (DTSQ). In: Bradley C, editor. Handbook of psychology and diabetes. Chur: Harwood Academic Publishers; 1994. p. 111–132.
   Google Scholar
• Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36:1384–1395.
   PubMed Web of Science ®Google Scholar
• Sanofi. Sanofi Announces Study Program Evaluating Toujeo® in a Real-Life Setting [Internet]. [ cited 2015 Jun 4]. Available from: http://www.prnewswire.com/news-releases/sanofi-announces-study-program-evaluating-toujeo-in-a-real-life-setting-300094110.html
   Google Scholar
• Garland EL, Roberts-Lewis A, Tronnier CD, et al. Mindfulness-Oriented Recovery Enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: proximal outcomes from a pragmatic randomized trial. Behav Res Ther. 2016;77:7–16.
   PubMed Web of Science ®Google Scholar
• Bender BG, Cvietusa PJ, Goodrich GK, et al. Pragmatic trial of health care technologies to improve adherence to pediatric asthma treatment: a randomized clinical trial. JAMA Pediatr. 2015;169:317–323.
   PubMed Web of Science ®Google Scholar
• Heisler M, Hofer TP, Schmittdiel JA, et al. Improving blood pressure control through a clinical pharmacist outreach program in patients with diabetes mellitus in 2 high-performing health systems: the adherence and intensification of medications cluster randomized, controlled pragmatic trial. Circulation. 2012;125:2863–2872.
   PubMed Web of Science ®Google Scholar