Impact of the 8-week administration of tofogliflozin for glycemic control and body composition in Japanese patients with type 2 diabetes mellitus

Internal Medicine

Volumn 55, Issue 22, 2016, Pages 3239-3245

  Hirose, Sachie ^a   Nakajima, Shinsuke ^b   Iwahashi, Yasuyuki ^a   Seo, Akane ^a   Takahashi, Tetsuya ^a   Tamori, Yoshikazu ^a,b  

^a Chibune General Hospital   (Japan)

^b KOBE UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

Body composition; Hemoconcentration; SGLT2 inhibitor; Tofogliflozin

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; CHLORIDE; CREATININE; GAMMA GLUTAMYLTRANSFERASE; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LACTATE DEHYDROGENASE; LOW DENSITY LIPOPROTEIN CHOLESTEROL; POTASSIUM; PROTEIN; SODIUM; TOFOGLIFLOZIN; 6-((4-ETHYLPHENYL)METHYL)-3',4',5',6'-TETRAHYDRO-6'-(HYDROXYMETHYL)SPIRO(ISOBENZOFURAN-1(3H),2'-(2H)PYRAN)-3',4',5'-TRIOL; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; GLUCOSE BLOOD LEVEL; GLUCOSIDE; GLYCOSYLATED HEMOGLOBIN;

ADULT; ARTICLE; ATAXIC GAIT; BODY COMPOSITION; BODY COMPOSITION ANALYZER; BODY MASS; BODY WEIGHT; CLINICAL ARTICLE; CLINICAL TRIAL; CORRELATION ANALYSIS; CYSTITIS; EXTRACELLULAR FLUID; FAT FREE MASS; FAT MASS; FEMALE; GLOMERULUS FILTRATION RATE; GLYCEMIC CONTROL; HEMOCONCENTRATION; HUMAN; KIDNEY FUNCTION; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; PLASMA OSMOLARITY; SINGLE DRUG DOSE; SWEAT GLAND DISEASE; TOTAL BODY WATER; URINARY EXCRETION FRACTION; BLOOD; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; JAPAN; METABOLISM; MIDDLE AGED;

ADULT; BENZHYDRYL COMPOUNDS; BLOOD GLUCOSE; BODY COMPOSITION; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCOSIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; JAPAN; MALE; MIDDLE AGED;

EID: 84995560961     PISSN: 09182918     EISSN: 13497235     Source Type: Journal    
DOI: 10.2169/internalmedicine.55.6367     Document Type: Article

References (37)

1. Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract 94: 311-321, 2011.
2. Inzucchi SE, Bergenstal RM, Buse JB, et al. American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). 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 35: 1364-1379, 2012.
3. DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab 14: 5-14, 2012.
4. Tahrani AA, Barnett AH, Bailey CJ. SGLT inhibitors in management of diabetes. Lancet Diabetes Endocrinol 1: 140-151, 2013.
5. Abdul-Ghani MA, Norton L, DeFronzo RA. Role of sodiumglucose cotransporter 2 (SGLT 2) inhibitors in the treatment of type 2 diabetes. Endocr Rev 32: 515-531, 2011.
6. Jan B, Östen L, Joel K, 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 97: 1020-1031, 2012.
7. Yabe D, Nishikino R, Kaneko M, Iwasaki M, Seino Y. Short-termimpacts of sodium/glucose co-transporter 2 inhibitors in Japanese clinical practice: considerations for their appropriate use to avoid serious adverse events. Expert Opin Drug Saf 14: 795-800, 2015.
8. Sartorio A, Malavolti M, Agosti F, et al. Body water distribution in severe obesity and its assessment from eight-polar bioelectrical impedance analysis. Eur J Clin Nutr 59: 155-160, 2005.
9. Ling CH, de Craen AJ, Slagboom PE, et al. Accuracy of direct segmental multi-frequency bioimpedance analysis in the assessment of total body and segmental body composition in middleaged adult population. Clin Nutr 30: 610-615, 2011.
10. Kim M, Shinkai S, Murayama H, Mori S. Comparison of segmental multifrequency bioelectrical impedance analysis with dualenergy X-ray absorptiometry for the assessment of body composition in a community-dwelling older population. Geriatr Gerontol Int 15: 1013-1022, 2015.
11. Androutsos O, Gerasimidis K, Karanikolou A, Reilly JJ, Edwards CA. Impact of eating and drinking on body composition measurements by bioelectrical impedance. J Hum Nutr Diet 28: 165-171, 2015.
12. Seino Y, Inagaki N, Haneda M, et al. Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig 6: 443-453, 2015.
13. Inagaki N, Kondo K, Yoshinari T, Maruyama N, Susuta Y, Kuki H. Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study. Diabetes Obes Metab 15: 1136-1145, 2013.
14. Kashiwagi A, Kazuta K, Yoshida S, Nagase I. Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus. J Diabetes Invest 5: 382-391, 2014.
15. 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, placebocontrolled, phase 3 trial. Diabetes Care 33: 2217-2224, 2010.
16. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet 375: 2223-2233, 2010.
17. Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, 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 13: 928-938, 2011.
18. Wilding JP, 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 32: 1656-1662, 2009.
19. Peene B, Benhalima K. Sodium glucose transporter protein 2 inhibitors: focusing on the kidney to treat type 2 diabetes. Ther Adv Endocrinol Metab 5: 124-136, 2014.
20. Sumiyoshi S, Shimono D, Futada T. Effects of SGLT2 inhibitors to body composition. Diabetes Frontier 26: 240-246, 2015 (in Japanese).
21. Matsuhashi Y, Chikazawa S, Matsui J, Daimon M. Administration of SGLT-2 inhibitor Ipraglifrozin improves Glycemic control and reduces the body weight and fat mass. Prog Med 34: 1867-1871, 2014 (in Japanese, Abstract in English).
22. Takagi S, Takagi M, Kiyama A, Nakamura N. Study of clinical effects of Ipragliflozin (SGLT2 inhibitor) and body composition changes by BIA (bioelectrocal impedance analysis). Prog Med 34: 2229-2235, 2014 (in Japanese, Abstract in English).
23. Scheen AJ. Pharmacodynamics, efficacy and safety of sodiumglucose co-transporter type 2 (SGLT2) inhibitors for the treatment of type 2 diabetes mellitus. Drugs 75: 33-59, 2015.
24. Ferrannini E, Muscelli E, Frascerra S, et al. Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients. J Clin Invest 124: 499-508, 2014.
25. Perkins BA, Cherney DZ, Partridge H, et al. Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial. Diabetes Care 37: 1480-1483, 2014.
26. Napolitano A, Miller S, Murgatroyd PR, et al. Exploring glycosuria as a mechanism for weight and fat mass reduction. A pilot study with remogliflozin etabonate and sergliflozin etabonate in healthy obese subjects. J Clin Transl Endocrinol 1: e3-e8, 2014.
27. Abdul-Ghani MA, DeFronzo RA, Norton L. Novel hypothesis to explain why SGLT2 inhibitors inhibit only 30-50% of filtered glucose load in humans. Diabetes 62: 3324-3328, 2013.
28. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet 375: 2223-2233, 2010.
29. Kaku K, Watada H, Iwamoto Y, et al. Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study. Cardiovasc Diabetol 13: 65, 2014.
30. Bolinder J, Ljunggren Ö, Johansson L, et al. 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 16: 159-169, 2014.
31. Ridderstråle M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, activecontrolled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol 2: 691-700, 2014.
32. Leiter LA, Yoon KH, Arias P, et al. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, Phase 3 study. Diabetes Care 38: 355-364, 2015.
33. Ferrannini G, Hach T, Crowe S, Sanghvi A, Hall KD, Ferrannini E. Energy balance after sodium-glucose cotransporter 2 inhibition. Diabetes Care 38: 1730-1735, 2015.
34. Scheen AJ, Van Gaal LF. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol 2: 911-922, 2014.
35. Shah N, Deeb W, Choksi R, Epstein B. Dapagliflozin: a novel sodium-glucose cotransporter type 2 inhibitor for the treatment of type 2 diabetes mellitus. Pharmacotherapy 32: 80-94, 2012.
36. Foote C, Perkovic V, Neal B. Effects of SGLT2 inhibitors on cardiovascular outcomes. Diab Vasc Dis Res 9: 117-123, 2012.
37. Go AS, Mozaffarian D, Roger VL, et al. Executive summary: heart disease and stroke statistics: 2013 update: a report from the American Heart Association. Circulation 127: 143-152, 2013.