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Clinical Focus: Diabetes and Concomitant Disorders

Safety and Tolerability of Canagliflozin in Patients With Type 2 Diabetes Mellitus: Pooled Analysis of Phase 3 Study Results

, MD, , MD, , BS, , PhD & , MD

References

  • . American Diabetes Association. Standards of medical care in diabetes—2013. Diabetes Care. 2013;36( suppl 1):S11–S66
  • . Neumiller JJ, White JR Jr, Campbell RK. Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs. 2010;70(4):377–385
  • . Inzucchi SE, Bergenstal RM, Buse JB, . 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(6):1364–1379
  • . Rosenstock J, Aggarwal N, Polidori D, . 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(6):1232–1238
  • . Stenlöf K, Cefalu WT, Kim K-A, . Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15(4):372–382
  • . Schernthaner G, Gross JL, Rosenstock J, . Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52–week, randomized trial. Diabetes Care. 2013;36(9):2508–2515
  • . Yale JF, Bakris G, Cariou B, . Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease. Diabetes Obes Metab. 2013;15(5):463–473
  • . Cefalu WT, Leiter LA, Yoon K-H, . Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013;382(9896):941–950
  • . Bode B, Stenlöf K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract. 2013;41(2):72–84
  • . Lavalle-González F, Januszewicz A, Davidson J, . Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56(12):2582–2592
  • . Wilding JP, Charpentier G, Hollander P, . Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial. Int J Clin Pract. 2013;67(12):1267–1282
  • . Forst T, Guthrie R, Goldenberg R, . Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes on background metformin and pioglitazone. Diabetes Obes Metab. 2014;16(5):467–477
  • . Nair S, Wilding JP. Sodium glucose cotransporter 2 inhibitors as a new treatment for diabetes mellitus. J Clin Endocrinol Metab. 2010;95(1):34–42
  • . Bailey CJ. Renal glucose reabsorption inhibitors to treat diabetes. Trends Pharmacol Sci. 2011;32(2):63–71
  • . Devineni D, Morrow L, Hompesch M, . Canagliflozin improves glycemic control over 28 days in subjects with type 2 diabetes not optimally controlled on insulin. Diabetes Obes Metab. 2012;14(6):539–545
  • . Polidori D, Sha S, Ghosh A, Plum-Morschel L, Heise T, Rothenberg P. Validation of a novel method for determining the renal threshold for glucose excretion in untreated and canagliflozin-treated subjects with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013;98(5):E867–E871
  • . INVOKANA™ (canagliflozin) tablets, for oral use [package insert]. Titusville, NJ: Janssen Pharmaceuticals, 2013
  • . Nyirjesy P, Sobel JD, Fung A, . Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies [published online ahead of print February 21, 2014]. Curr Med Res Opin. doi:10.1185/03007995.2014.890925
  • . Nicolle LE, Capuano G, Fung A, Usiskin K. Urinary tract infection in randomized Phase III studies of canagliflozin, a sodium glucose co-transporter 2 inhibitor. Postgrad Med. 2014;126(1):7–17
  • . Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complications. 2013;27(5):479–484
  • . Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Urinary tract infections in patients with diabetes treated with dapagliflozin. J Diabetes Complications. 2013;27(5):473–478
  • . Rosenstock J, Seman LJ, Jelaska A, . Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia. Diabetes Obes Metab. 2013;15(12):1154–1160
  • . Haring HU, Merker L, Seewaldt-Becker E, . Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013;36(11):3396–3404
  • . FARXIGA™ (dapagliflozin) tablets, for oral use [package insert]. Princeton, NJ: Bristol-Myers Squibb Company, 2014
  • . Lambers Heerspink HJ, de ZD, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013;15(9):853–862
  • . Williams-Herman D, Round E, Swern AS, . Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis. BMC Endocr Disord. 2008;8:14
  • . Williams-Herman D, Engel SS, Round E, . Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord. 2010;10:7
  • . Engel SS, Round E, Golm GT, Kaufman KD, Goldstein BJ. Safety and tolerability of sitagliptin in type 2 diabetes: pooled analysis of 25 clinical studies. Diabetes Ther. 2013;4(1):119–145
  • . Weidmann P, de Court, Ferrari P. Effect of diuretics on the plasma lipid profile. Eur Heart J. 1992;13 Suppl G:61–67
  • . Hach T, Gerich JE, Salsali A, . Empagliflozin improves glycemic parameters and cardiovascular risk factors in patients with type 2 diabetes (T2DM): pooled data from four pivotal phase III trials. Diabetes. 2013;62( suppl 1):LB19
  • . Neal B, Perkovic V, de Zeeuw D, . Rationale, design, and baseline characteristics of the canagliflozin cardiovascular assessment study (CANVAS)—a randomized placebo-controlled trial. Am Heart J. 2013;166(2):217–223

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