U300, a novel long-acting insulin formulation

Bibliography

• Ryden L, Grant PJ, Anker SD, et al. ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J 2013;34:3035-87
   PubMed Web of Science ®Google Scholar
• Atkinson MA, Eisenbarth GS, Michels AW. Type 1 diabetes. Lancet 2014;383:69-82
   PubMed Web of Science ®Google Scholar
• Nolan CJ, Damm P, Prentki M. Type 2 diabetes across generations: from pathophysiology to prevention and management. Lancet 2011;378:169-81
   PubMed Web of Science ®Google Scholar
• Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia 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). Diabetologia 2012;55:1577-96
   PubMed Web of Science ®Google Scholar
• Hilgenfeld R, Seipke G, Berchtold H, et al. The evolution of insulin glargine and its continuing contribution to diabetes care. Drugs 2014;74:911-27
   PubMed Web of Science ®Google Scholar
• Owens DR, Matfin G, Monnier L. Basal insulin analogues in the management of diabetes mellitus: what progress have we made? Diabetes Metab Res Rev 2014;30:104-19
   PubMed Web of Science ®Google Scholar
• Barnett AH. Insulin glargine in the treatment of type 1 and type 2 diabetes. Vasc Health Risk Manag 2006;2:59-67
   PubMedGoogle Scholar
• Goykhman S, Drincic A, Desmangles JC, et al. Insulin Glargine: a review 8 years after its introduction. Expert Opin Pharmacother 2009;10:705-18
   PubMed Web of Science ®Google Scholar
• Horvath K, Jeitler K, Berghold A, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007;CD005613
   Google Scholar
• Mullins P, Sharplin P, Yki-Jarvinen H, et al. Negative binomial meta-regression analysis of combined glycosylated hemoglobin and hypoglycemia outcomes across eleven Phase III and IV studies of insulin glargine compared with neutral protamine Hagedorn insulin in type 1 and type 2 diabetes mellitus. Clin Ther 2007;29:1607-19
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Dailey G, Massi-Benedetti M, et al. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care 2005;28:950-5
   PubMed Web of Science ®Google Scholar
• Home PD, Bolli GB, Mathieu C, et al. Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naive people with type 2 diabetes. Diabetes Obes Metab 2014. [Epub ahead of print]
   Web of Science ®Google Scholar
• Garber AJ, King AB, Del Prato S, et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012;379:1498-507
   PubMed Web of Science ®Google Scholar
• Evans M, Schumm-Draeger PM, Vora J, et al. A review of modern insulin analogue pharmacokinetic and pharmacodynamic profiles in type 2 diabetes: improvements and limitations. Diabetes Obes Metab 2011;13:677-84
   PubMed Web of Science ®Google Scholar
• Steinstraesser A, Schmidt R, Bergmann K, et al. Investigational new insulin glargine 300 U/ml has the same metabolism as insulin glargine 100 U/ml. Diabetes Obes Metab 2014
   PubMedGoogle Scholar
• Sanofi. FDA Accepts Sanofi’s New Drug Application for Basal Insulin Toujeo®. 2014. Available from: http://en.sanofi.com/Images/36859_20140708_toujeo_en.pdf [Cited 21 July 2014]
   Google Scholar
• Tillner JA, Bergmann K, Teichert L, et al. Euglycemic clamp profile of new insulin glargine U300 formulation in patients with type 1 diabetes (T1DM) is different from glargine U100. Diabetes 2013;62:A234
   PubMed Web of Science ®Google Scholar
• Shiramoto M, Eto T, Watanabe A, et al. Single dose of new insulin glargine Gla-300 formulation has a flatter and prolonged PK/PD profile than Gla-100 in Japanese subjects with type 1 diabetes. Diabetologia 2013;56:A1031
   PubMedGoogle Scholar
• Sanofi. Clinical study results. Phase I in Japanese patients with type 1 diabetes mellitus]. 2013. Available from: http://en.sanofi.com/img/content/study/pdy12777-summary.pdf [Cited 07 July 2014]
   Google Scholar
• Jax J, Heise T, Dahmen R, et al. New insulin glargine formulation has a flat and prolonged steady state profile in subjects with type 1 diabetes. Diabetologia 2013;56:A1029
   Google Scholar
• Becker RHA, 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 2014. [ Epub ahead of print]
   Web of Science ®Google Scholar
• Becker RHA, Nowotny I, Teichert L, et al. Low within- and between-day variability in exposure to new insulin glargine 300 U.ml-1. Am Diabetes Assoc 2014;2014;abstract 892-P
   Google Scholar
• Sanofi. Clinical study results. Phase II clinical trial in patients with type 1 diabetes mellitus]. 2014. Available from: http://en.sanofi.com/img/content/study/pdy12777-summary.pdf [Cited 07 July 2014]
   Google Scholar
• Home PD, Bergenstal RM, Riddle MC, et al. Glycemic control and hypoglycemia with new insulin glargine 300U/ml in people with T1DM (EDITION 4). Am Diabetes Assoc 2014;2014:abstract 80-LB
   Google Scholar
• Matsuhisa M, Koyama M, Cheng X, et al. New insulin glargine 300 U/mL: glycemic control and hypoglycemia in Japanese people with T1DM (EDITION JP 1). Am Diabetes Assoc 2014;2014:abstract 88-LB
   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(10):2755-62
   PubMed Web of Science ®Google Scholar
• Riddle MC, Bolli GB, Yki-Jarvinen H, et al. Sustained glycemic control and less hypoglycemia with new insulin glargine 300 U/mL compared with 100 U/ml: one-year results in people with T2DM using basal + mealtime insulin (EDITION 1). Am Diabetes Assoc 2014;2014:abstract 81-LB
   Google Scholar
• Yki-Jarvinen H, Bergenstal RM, Bolli GB, et al. Less nocturnal hypoglycemia and weight gain with new insulin glargine 300 U/ml compared with 100 U/ml: 1-year results in people wwith T2DM using basal insulin with OADs (EDITION 2). Am Diabetes Assoc 2014;2014:abstract 93-LB
   Google Scholar
• Yki-Jarvinen H, Bergenstal R, Ziemen M, et al. New insulin glargine 300 U/mL versus glargine 100 U/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. [Epub ahead of print]
   PubMedGoogle Scholar
• Riddle MC, Bolli GB, Home PD, et al. New insulin glargine 300 U/ml: efficacy and safety of adaptable vs. fixed dosing intervals in people with T2DM. Am Diabetes Assoc 2014;2014:abstract 919-P
   Google Scholar
• Bolli GB, Riddle MC, Bergenstal RM, et al. New insulin glargine 300 U/ml: glycaemic control and hypoglycaemia in insulin-naive people with type 2 diabetes mellitus (EDITION 3). Am Diabetes Assoc (San Francisco) 2014;2014:abstract 947
   Google Scholar
• Ritzel R, Roussel R, Bolli G, et al. New insulin glargine 300 U/mL: glycemic control and hypoglycemia in a meta-analysis of phase 3a EDITION clinical trials in people with T2DM. Am Diabetes Assoc 2014;2014:abstract 90-LB
   Google Scholar
• Terauchi Y, Koyama M, Cheng X, et al. Glycemic control and hypoglycemia in Japanese people with T2DM receiving new insulin glargine 300 U/mL in combination with OADs (EDITOIN JP 2). Am Diabetes Assoc 2014;2014:abstract 94-LB
   Google Scholar
• Pieber TR, Treichel HC, Hompesch B, et al. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med 2007;24:635-42
   PubMed Web of Science ®Google Scholar
• Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther 2009;31:2086-97
   PubMed Web of Science ®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 Ther 2008;30:1976-87
   PubMed Web of Science ®Google Scholar
• Raskin P, Gylvin T, Weng W, et al. Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes. Diabetes Metab Res Rev 2009;25:542-8
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Davies M, Home PD, et al. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008;51:408-16
   PubMed Web of Science ®Google Scholar
• Swinnen SG, Dain MP, Aronson R, et al. A 24-week, randomized, treat-to-target trial comparing initiation of insulin glargine once-daily with insulin detemir twice-daily in patients with type 2 diabetes inadequately controlled on oral glucose-lowering drugs. Diabetes Care 2010;33:1176-8
   PubMed Web of Science ®Google Scholar
• Davies MJ, Gagliardino JJ, Gray LJ, et al. Real-world factors affecting adherence to insulin therapy in patients with type 1 or type 2 diabetes mellitus: a systematic review. Diabet Med 2013;30:512-24
   PubMed Web of Science ®Google Scholar
• Peyrot M, Barnett AH, Meneghini LF, et al. Insulin adherence behaviours and barriers in the multinational global attitudes of patients and physicians in insulin therapy study. Diabet Med 2012;29:682-9
   PubMed Web of Science ®Google Scholar
• Pontiroli AE, Miele L, Morabito A. Increase of body weight during the first year of intensive insulin treatment in type 2 diabetes: systematic review and meta-analysis. Diabetes Obes Metab 2011;13:1008-19
   PubMed Web of Science ®Google Scholar
• Mellbin LG, Ryden L, Riddle MC, et al. Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial. Eur Heart J 2013;34:3137-44
   PubMed Web of Science ®Google Scholar
• Investigators OT, Gerstein HC, Bosch J, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012;367:319-28
   PubMed Web of Science ®Google Scholar
• Andrews MA, O’Malley PG. Diabetes overtreatment in elderly individuals: risky business in need of better management. JAMA 2014;311:2326-7
   PubMed Web of Science ®Google Scholar
• Willis WD, Diago-Cabezudo JI, Madec-Hily A, et al. Medical resource use, disturbance of daily life and burden of hypoglycemia in insulin-treated patients with diabetes: results from a European online survey. Exp Rev Pharmacoecon Outcomes Res 2013;13:123-30
   PubMed Web of Science ®Google Scholar
• Hammer M, Lammert M, Mejias SM, et al. Costs of managing severe hypoglycaemia in three European countries. Journal of medical economics 2009;12:281-90
   PubMedGoogle Scholar
• Lamy A, Tong W, Jung H, et al. Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial. J Diabetes Complications 2014;28:553-8
   PubMed Web of Science ®Google Scholar
• Approval package for application number NDA 21-081/S-024. 2007. Available from: www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021081Orig1s024.pdf] [Cited 25 August 2014]
   Google Scholar
• Sanofi Diabetes. Advancing Science: investigational new insulin U300. 2013. Available from: www.google.de/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=2&cad=rja&uact=8&ved=0CCQFjAB&url=http%3A%2F%Fwww.epresspack.net%Fsanofi-at-ada%Fdownload%F%3Fid%D362%26pn%3D831723-pdf&ei=VDz7U7PUB-6g7Abd-YHICw&usg=AFQjCNFXEjzGnKz7L0eMwSCrakty19B5cw&bvm=bv.73612305,d.bGE] [Cited 25 August 2014]
   Google Scholar