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«The Dapagliflozin Bibliography Program-Level Data Review and Synthesis 1. Ptaszynska A, Hardy E, Johnsson E, Parikh S, List J. Effects of ...»

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Updated September 26, 2013

The Dapagliflozin Bibliography

Program-Level Data Review and Synthesis

1. Ptaszynska A, Hardy E, Johnsson E, Parikh S, List J. Effects of dapagliflozin on

cardiovascular risk factors. Postgrad Med. 2013;27(5):473–8.

doi:10.1016/j.jdiacomp.2013.05.004

2. 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 Sep-Oct;27(5):479-84. doi:

10.1016/j.jdiacomp.2013.04.012.

3. 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 Sep-Oct;27(5):473-8. doi: 10.1016/j.jdiacomp.2013.05.004.

4. Whaley JM, Tirmenstein M, Reilly TP, Poucher SM, Saye J, Parikh S, List JF.

Targeting the kidney and glucose excretion with dapagliflozin: preclinical and clinical evidence for SGLT2 inhibition as a new option for treatment of type 2 diabetes mellitus. Diabetes Metab Syndr Obesity Targ Ther. 2012;5:135-148.

5. Jabbour SA, Whaley JM, Tirmenstein M, Poucher SM, Reilly TP, Boulton DW, Saye J, List JF, Parikh S. Targeting renal glucose reabsorption for the treatment of type 2 diabetes mellitus using the SGLT2 inhibitor dapagliflozin. Postgrad Med. 2012;124(4):62-73.

6. Pfister M, Whaley JM, Zhang L, List JF. Inhibition of SGLT2: A novel strategy for treatment of type 2 diabetes mellitus. Clin Pharmacol Ther. 2011;89(4):621-625.

7. Zhang L, Feng Y, List J, Kasichayanula S, Pfister M. Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight. Diabetes Obes Metab. 2010;12(6):510-516.

8. Zhang L, Ng CM, List JF, Pfister M. Synergy between scientific advancement and technological innovation, illustrated by a mechanism-based model characterizing sodium–glucose cotransporter-2 inhibition. J Clin Pharmacol. 2010;50(9):113S- 120S.

9. Meng W, Ellsworth BA, Nirschl AA, McCann PJ, Patel M, Girotra RN, Wu G, Sher PM, Morrison EP, Biller SA, Zahler R, Deshpande PP, Pullockaran A, Hagan DL, Morgan N, Taylor JR, Obermeier MT, Humphreys WG, Khanna A, Discenza L, 1 Updated September 26, 2013 Robertson JG, Wang A, Han S, Wetterau JR, Janovitz EB, Flint OP, Whaley JM, Washburn WN. Discovery of dapagliflozin: a potent, selective renal sodium- dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes. J Med Chem. 2008;51(5):1145-1149.

Key Clinical Trials

10. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy

in type 2 diabetic patients with inadequate glycemic control by diet and exercise:

a randomized, double-blind, placebo-controlled, phase III trial. Diabetes Care.

2010;33(10):2217-2224.

11. Nauck MA, Del Prato S, Meier J, Durán-García S, Rohwedder K, Elze M, Parikh S. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled non-inferiority trial. Diabetes Care.

2011;34(9):2015-2022.

German translation: Dtsch Med Wochenschr. 2013 April;138(suppl 1):S6-S15.

12. Bailey C, Gross J, Pieters A, Bastien A, List J. 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(9733):2223Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo controlled 102-week trial. BMC Med.

2013;11(1):43.

14. Strojek K, Yoon K, Hruba V, Elze M, Langkilde A, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomised, 24-week, double-blind, placebo-controlled trial.

Diabetes Obes Metab. 2011:13(10):928-938.

German translation: Dtsch Med Wochenschr. 2013 April;138(suppl 1):S16-S26.

15. Wilding J, Soler N, Woo V, Rohwedder K. Long-term efficacy of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: a randomized, controlled trial. Ann Intern Med. 2012;156(6):405-415.

German translation: Dtsch Med Wochenschr. 2013 April;138(suppl 1):S27-S38.

16. Wilding JPH, Woo V, Rohwedder K, Sugg J, Parikh S. Dapagliflozin in Patients With Type 2 Diabetes Receiving High Doses of Insulin: Efficacy and Safety Over Two Years. Diabetes Obes Metab. 2013 Aug 1. doi: 10.1111/dom.12187. [Epub ahead of print]

17. Bolinder J, Ljunggren O, Kullberg J, Johansson L, Langkilde A. 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(3):1020-1031.

18. Ljunggren O, Bolinder J, Johansson L,Wilding J, Langkilde AM, Sjöström CD, Sugg J, Parikh S. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab. 2012 November;14(11):990-999.





19. Bolinder J, Ljunggren Ö, Johansson L, Wilding J, Langkilde AM, Sjöström CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus

inadequately controlled on metformin. Diabetes Obes Metab. 2013 Aug 1. doi:

10.1111/dom.12189. [Epub ahead of print] Bailey CJ, Iqbal N, T’joen C, List JF. Dapagliflozin monotherapy in drug-naïve 20.

patients with diabetes: a randomized-controlled trial of low-dose range. Diabetes Obes Metab. 2012;14(10):951-959.

21. Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska Agata, List JF.

Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;65(5):446-456.

22. Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, on hemoglobin A1c, body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012;35(7):1473-1478.

23. Kaku K, Inoue S, Matsuoka O, Kiyosue A, Azuma H, Hayashi N, Tokudome T, Langkilde AM, Parikh S. 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 May;15(5):432-440.

24. Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2013 Sep

25. doi 10.1038/ki.2013.356

–  –  –

Clinical Pharmacology and Early Clinical Data

25. Yang L, Li H, Li H, Bui A, Chang M, Liu X, Kasichayanula S, Griffen SC, Lacreta FP, Boulton DW. Pharmacokinetic and pharmacodynamic properties of singleand mulitple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Clin Ther. 2013 Aug;35(8):1211-1222.e2.

26. van der Walt JS, Hong Y, Zhang L, Pfister M, Boulton D, Karlsson M. A Nonlinear Mixed Effects Pharmacokinetic Model for Dapagliflozin and Dapagliflozin 3-O-glucuronide in Renal or Hepatic Impairment. CPT Pharmacometrics Syst Pharmacol. 2013 May; 2(5): e42.

27. Defronzo RA, Hompesch M, Kasichayanula S, Liu X, Hong Y, Pfister M, Morrow LA, Leslie BR, Boulton DW, Ching A, Lacreta FP, Griffen SC. Characterization of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and Subjects With Type 2 Diabetes. Diabetes Care. 2013 Jun 4. [Epub ahead of print]

28. Gould JC, Kasichayanula S, Shepperly DC, Boulton DW. Use of low-dose clinical pharmacodynamic and pharmacokinetic data to establish an occupational

exposure limit for dapagliflozin, a potent inhibitor of the renal sodium glucose cotransporter 2. Regul Toxicol Pharmacol. 2013 Oct;67(1):89-97. doi:

10.1016/j.yrtph.2013.07.002.

29. Kasichayanula S, Liu X, LaCreta F, Griffen SC, Boulton D. Clinical pharmacokinetics and pharmacodynamics profile of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2. Clinical Pharmacokinetics. in press.

30. Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucoseregulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013 Sep;15(9):853-62. doi: 10.1111/dom.12127.

31. Kasichayanula S, Liu X, Griffen S, LaCreta F, Boulton D. Effects of rifampin and mefenamic acid on the pharmacokinetics and pharmacodynamics of dapagliflozin. Diabetes Obes Metab. 2013 March;15(3):280-283.

32. Imamura A, Kusunoki M, Ueda S, Hayashi N, Imai Y. Impact of voglibose on the pharmacokinetics of dapagliflozin in Japanese patients with type 2 diabetes.

Diabetes Ther. 2013 Jun;4(1):41-9. doi: 10.1007/s13300-012-0016-5.

33. Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta F, Humphreys W, Boulton D. The influence of kidney function on dapagliflozin exposure, metabolism, and efficacy in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056.

–  –  –

determine the absolute oral bioavailability of saxagliptin and dapagliflozin. Br J Clin Pharmacol. 2013;75(3):763-768.

35. Kasichayanula S, Chang M, Liu X, Shyu WC, Griffen SC, LaCreta FP, Boulton DW. Lack of pharmacokinetic interactions between dapagliflozin and simvastatin, valsartan, warfarin, or digoxin. Adv Ther. 2012;29(2):163-177.

36. Carlson G, Tou C, Parikh S, Birmingham B, Butler K. Evaluation of the effect of dapagliflozin on cardiac repolarization: a thorough QT/QTc study. Diabetes Ther.

2011;2(3):123-132.

37. Kasichayanula S, Liu X, Zhang W, Pfister M, Reele SB, Aubry AF, LaCreta FP, Boulton DW. Effect of a high-fat meal on the pharmacokinetics of dapagliflozin, a selective SGLT2 inhibitor, in healthy subjects. Diabetes Obes Metab.

2011;13(8):770-773.

38. Kasichayanula S, Liu X, Shyu WC, Zhang W, Pfister M, Griffen SC, Li T, LaCreta FP, Boulton DW. Lack of pharmacokinetic interaction between dapagliflozin, a novel SGLT2 inhibitor, and metformin, pioglitazone, glimepiride, or sitagliptin in healthy subjects. Diabetes Obes Metab. 2011;13(1):47-54.

39. Kasichayanula S, Chang M, Hasegawa M, Liu X, Yamahira N, LaCreta FP, Imai Y, Boulton DW. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium–glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab.

2011;13(4):357-365.

40. Kasichayanula S, Liu X, Zhang W, Pfister M, LaCreta F, Boulton D. Influence of

hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin:

An open-label, parallel-group, single-dose study. Clin Ther. 2011;33(11):1798Wilding JPH, Norwood P, T'joen C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment.

Diabetes Care. 2009;32(9):1656-1662.

42. List J, Woo V, Morales E, Tang W, Fiedorek F. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care. 2009;32(4):650Komoroski B, Vachharajani N, Boulton D, Kornhauser D, Geraldes M, Li L, Pfister M. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther. 2009;85(5):520-526.

44. Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M.

Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over

–  –  –

2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther.

2009;85(5):513-519.

Nonclinical Data

45. Tirmenstein M, Dorr T, Janovitz E, Whaley J, Abell L, Onorato J, Hagan D, Reilly T. Nonclinical Toxicology Assessments Support the Chronic Safety of Dapagliflozin, A First-in-Class Sodium-Glucose Cotransporter 2 Inhibitor, for Type 2 Diabetes Patients. Int J Toxicol. In press.

46. Devenny JJ, Godonis HE, Harvey SJ, Cullen MJ, Pelleymounter MA. Weight loss induced by chronic dapagliflozin treatment is attenuated by compensatory

hyperphagia in diet induced obese (DIO) rats. Obesity. 2012; doi:

10.1038/oby.2012.59

47. Thomson SC, Rieg T, Miracle C, Mansoury H, Whaley J, Vallon V, Singh P.

Acute and chronic effects of SGLT2 blockade on glomerular and tubular function in the early diabetic rat. Am J Phsyiol Regul Integr Comp Physiol.

2012;302(1):R75-R83.

48. Hummel CS, Lu C, Liu J, Ghezzi C, Hirayama BA, Loo DD, Kepe V, Barrio JR, Wright EM. Structural selectivity of human SGLT inhibitors. Am J Physiol Cell Physiol. 2012;302(2):C373-382.

Independently sponsored study supports and offers a kinetic explanation for dapagliflozin selectivity for SGLT2 versus SGLT1

49. Macdonald FR, Peel JE, Jones HB, Mayers RM, Westgate L, Whaley JM, Poucher SM. The novel sodium glucose transporter 2 inhibitor dapagliflozin sustains pancreatic function and preserves islet morphology in obese, diabetic rats. Diabetes Obes Metab. 2010;12(11):1004-1012.

50. Obermeier MT, Yao M, Khanna A, Koplowitz B, Zhu M, Li W, Komoroski B, Kasichayanula S, Discenza L, Washburn W, Meng W, Ellsworth BA, Whaley JM, Humphreys WG. In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II (SGLT2) inhibitor, in animals and humans. Drug Metab Dispos. 2010;38(3):405-414.



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