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Original Research

Long-term safety and efficacy of tofogliflozin, a selective inhibitor of sodium-glucose cotransporter 2, as monotherapy or in combination with other oral antidiabetic agents in Japanese patients with type 2 diabetes mellitus: multicenter, open-label, randomized controlled trials

, MD PhD, , MD PhD, , MD PhD, , MD PhD, , MD PhD, , MD PhD, , MD PhD, , MD PhD, , , PhD, , PhD & show all

Bibliography

  • IDF diabetes atlas 6th edition, 2012 update. Brussels, Belgium: international Diabetes Federation, 2012. Available from: www.diabetesatlas.org [Last accessed 20 December 2013]
  • Hsu WC. Consequences of delaying progression to optimal therapy in patients with type 2 diabetes not achieving glycemic goals. South Med J 2009;102:67-76
  • Management of diabetes. A national clinical guideline. Edinburgh, UK: Scottish Intercollegiate Guidelines Network, 2010. Available from: www.sign.ac.uk/guidelines/index.html [Last accessed 20 December 2013]
  • Vilsbøll T, Christensen M, Junker AE, et al. Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. BMJ 2012;344:d7771
  • Kanai Y, Lee WS, You G, et al. The human kidney low affinity Na+/glucose cotransporter SGLT2. Delineation of the major renal reabsorptive mechanism for D-glucose. J Clin Invest 1994;93:397-404
  • Wright EM, Hirayama BA, Loo DF. Active sugar transport in health and disease. J Intern Med 2007;261:32-43
  • List JF, Woo V, Morales E, et al. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care 2009;32:650-7
  • Ferrannini E, Ramos SJ, Salsali A, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 2010;33:2217-24
  • Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med 2012;156:405-15
  • Rosenstock J, Aggarwal N, Polidori D, et al. Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes. Diabetes Care 2012;35:1232-8
  • Devineni D, Morrow L, Hompesch M, et al. Canagliflozin improves glycaemic control over 28 days in subjects with type 2 diabetes not optimally controlled on insulin. Diabetes Obes Metab 2012;14:539-45
  • Suzuki M, Honda K, Fukazawa M, et al. Tofogliflozin, a potent and highly specific sodium/glucose cotransporter 2 inhibitor, improves glycemic control in diabetic rats and mice. J Pharmacol Exp Ther 2012;341:692-701
  • Nagata T, Fukazawa M, Honda K, et al. Selective SGLT2 inhibition by tofogliflozin reduces renal glucose reabsorption under hyperglycemic but not under hypo- or euglycemic conditions in rats. Am J Physiol Endocrinol Metab 2013;304:E414-23
  • ICH harmonised tripartite guideline: the extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1994. Available from: www.ich.org/products/guidelines.html [Last accessed 20 December 2013]
  • Guideline for clinical evaluation of oral hypoglycemic agents. Tokyo, Japan: Ministry of Health, Labour and Welfare, 2010. Available from: www.pmda.go.jp [Last accessed 20 December 2013]
  • Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin. Diabetes Care 2011;34:2015-22
  • Kim Y, Babu AR. Clinical potential of sodium-glucose cotransporter 2 inhibitors in the management of type 2 diabetes. Diabetes Metab Syndr Obes 2012;5:313-27
  • Kaku K, Inoue S, Matsuoka O, et al. Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a Phase II multicentre, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab 2013;5:432-40
  • Bolinder J, Ljunggren Ö, Kullberg J, et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab 2012;97:1020-31
  • Bailey CJ, Gross JL, Pieters A, et al. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet 2010;375:2223-33
  • Ferrannini E. Sodium-glucose transporter-2 inhibition as an antidiabetic therapy. Nephrol Dial Transplant 2010;25:2041-3
  • Invokana™ prescribing information. Titusville, NJ: Janssen Pharmaceuticals, Inc., 2013. Available from: www.invokanahcp.com [Last accessed 20 December 2013]

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