Long-term safety and efficacy of tofogliflozin as add-on to insulin in patients with type 2 diabetes: Results from a 52-week, multicentre, randomized, double-blind, open-label extension, Phase 4 study in Japan (J-STEP/INS)

Diabetes, Obesity and Metabolism

Volumn 20, Issue 5, 2018, Pages 1176-1185

  Terauchi, Yasuo ^a   Tamura, Masahiro ^b   Senda, Masayuki ^b   Gunji, Ryoji ^c   Kaku, Kohei ^d  

^a YOKOHAMA CITY UNIVERSITY   (Japan)

^b Sanofi KK ^*  (Japan)

^c KOWA COMPANY LTD   (Japan)

^d KAWASAKI MEDICAL SCHOOL   (Japan)

Author keywords

basal insulin; randomized trial; SGLT2 inhibitor; type 2 diabetes; weight control

Indexed keywords

BETA 2 MICROGLOBULIN; CREATINE KINASE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; HEMOGLOBIN A1C; INSULIN; KETONE BODY; PLACEBO; 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; GLUCOSIDE; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

ABDOMINAL PAIN; ABNORMAL URINE COMPOSITION; ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADD ON THERAPY; ADULT; AGED; ANKLE FRACTURE; ARTICLE; ASTEATOTIC ECZEMA; BODY WEIGHT LOSS; CELLULITIS; COLD URTICARIA; CONSTIPATION; CONTACT DERMATITIS; CONTROLLED STUDY; CORONARY ARTERY OBSTRUCTION; CREATINE KINASE BLOOD LEVEL; CYSTITIS; DAYTIME HYPOGLYCEMIA; DEHYDRATION; DERMATITIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; ECZEMA; FEMALE; GASTROENTERITIS; GENITAL TRACT INFECTION; GLYCEMIC CONTROL; HEART FAILURE; HEART INFARCTION; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; JAPAN; KETOGENESIS; KETONURIA; MAJOR CLINICAL STUDY; MALE; MICTURITION DISORDER; MONOTHERAPY; MULTICENTER STUDY; NOCTURIA; NOCTURNAL HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PERIARTHRITIS; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHARYNGITIS; PHASE 4 CLINICAL TRIAL; POLLAKISURIA; POLYURIA; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SKIN DISEASE; SPONDYLOLISTHESIS; SWEAT GLAND DISEASE; THIRST; TREATMENT DURATION; UNCONSCIOUSNESS; URINARY TRACT INFECTION; URTICARIA; VAGINITIS; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; ETHNOLOGY; FOLLOW UP; HYPERGLYCEMIA; INCIDENCE; INSULIN RESISTANCE; METABOLISM; MIDDLE AGED; MULTIDRUG RESISTANCE; RISK; YOUNG ADULT;

ADULT; AGED; BENZHYDRYL COMPOUNDS; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DOUBLE-BLIND METHOD; DRUG RESISTANCE, MULTIPLE; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; GLUCOSIDES; GLYCATED HEMOGLOBIN A; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INCIDENCE; INSULIN; INSULIN RESISTANCE; JAPAN; MALE; MIDDLE AGED; RISK; SODIUM-GLUCOSE TRANSPORTER 2 INHIBITORS; YOUNG ADULT;

EID: 85041703052     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.13213     Document Type: Article

References (35)

1. 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.
2. Poole RM, Prossler JE. Tofogliflozin: first global approval. Drugs. 2014;74:939-944.
3. Tanizawa Y, Kaku K, Araki E, et al. 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. Expert Opin Pharmacother. 2014;15:749-766.
4. Ikeda S, Takano Y, Cynshi O, et al. A novel and selective sodium-glucose cotransporter-2 inhibitor, tofogliflozin, improves glycaemic control and lowers body weight in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015;17:984-993.
5. Wulffelé MG, Kooy A, Lehert P, et al. Combination of insulin and metformin in the treatment of type 2 diabetes. Diabetes Care. 2002;25:2133-2140.
6. Sato S, Saisho Y, Kou K, et al. Efficacy and safety of sitagliptin added to insulin in Japanese patients with type 2 diabetes: the EDIT randomized trial. PLoS One. 2015;10:e0121988.
7. American Diabetes Association. 7. Approaches to glycemic treatment. Diabetes Care. 2016;39(suppl 1):S52-S59.
8. Terauchi Y, Tamura M, Senda M, Gunji R, Kaku K. Efficacy and safety of tofogliflozin in Japanese patients with type 2 diabetes mellitus with inadequate glycaemic control on insulin therapy (J-STEP/INS): results of a 16 week randomized, double-blind, placebo-controlled multicentre trial. Diabetes Obes Metab. 2017;19:1397-1407.
9. DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab. 2012;14:5-14.
10. Rosenstock J, Jelaska A, Frappin G, et al. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014;37:1815-1823.
11. Neal B, Perkovic V, de Zeeuw D, et al. Efficacy and safety of canagliflozin, an inhibitor of sodium-glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care. 2015;38:403-411.
12. Araki E, Onishi Y, Asano M, Kim H, Yajima T. Efficacy and safety of dapagliflozin over 1 year as add-on to insulin therapy in Japanese patients with type 2 diabetes: the DAISY (Dapagliflozin added to patients under InSulin therapY) trial. Diabetes Obes Metab. 2017;19:562-570.
13. Kim Y, Babu AR. Clinical potential of sodium-glucose cotransporter 2 inhibitors in the management of type 2 diabetes. Diabetes Metab Syndr Obes. 2012;5:313-327.
14. Inagaki N, Harashima S, Maruyama N, Kawaguchi Y, Goda M, Iijima H. Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2016;15:89.
15. Ishihara H, Yamaguchi S, Nakao I, Okitsu A, Asahina S. Efficacy and safety of ipragliflozin as add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a multi-centre, randomized, placebo-controlled, double-blind study. Diabetes Obes Metab. 2016;18:1207-1216.
16. Erondu N, Desai M, Ways K, Meininger G. Diabetic ketoacidosis and related events in the canagliflozin type 2 diabetes clinical program. Diabetes Care. 2015;38:1680-1686.
17. Zinman B, Wanner C, Lachin JM, et al. EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117-2128.
18. Jabbour S, Seufert J, Scheen A, Bailey CJ, Karup C, Langkilde AM. Dapagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of safety data from phase IIb/III clinical trials. Diabetes Obes Metab. 2018;20:620–628.
19. Blau JE, Tella SH, Taylor SI, Rother KI. Ketoacidosis associated with SGLT2 inhibitor treatment: analysis of FAERS data. Diabetes Metab Res Rev. 2017 Nov;33(8). https://doi.org/10.1002/dmrr.2924.
20. Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377:644-657.
21. Food and Drug Administration. FDA drug safety communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. 2015. Available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM446954.pdf. Accessed December 4, 2017.
22. Food and Drug Administration. FDA drug safety communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. 2015. Available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM475487.pdf. Accessed December 4, 2017.
23. Food and Drug Administration. FDA drug safety communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). 2017. Available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM558427.pdf. Accessed December 4, 2017.
24. Rosenstock J, Jelaska A, Zeller C, et al. EMPA-REG BASALTM trial investigators. Impact of empagliflozin added on to basal insulin in type 2 diabetes inadequately controlled on basal insulin: a 78-week randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2015;17:936-948.
25. Wilding JP, Woo V, Rohwedder K, Sugg J, Parikh S, Dapagliflozin 006 Study Group. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab. 2014;16:124-136.
26. Stenlöf K, Cefalu WT, Kim KA, et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15:372-382.
27. Fadini GP, Bonora BM, Zatti G, et al. Effects of the SGLT2 inhibitor dapagliflozin on HDL cholesterol, particle size, and cholesterol efflux capacity in patients with type 2 diabetes: a randomized placebo-controlled trial. Cardiovasc Diabetol. 2017;16:42.
28. Rosenstock J, Seman LJ, Jelaska A, et al. 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;15:1154-1160.
29. Schernthaner G, Gross JL, Rosenstock J, et al. 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;36:2508-2515.
30. Qiu R, Capuano G, Meininger G. Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus. J Clin Transl Endocrinol. 2014;1:54-60.
31. Suzuki K, Mitsuma Y, Sato T, Anraku T, Hatta M. Comparison of combined Tofogliflozin and glargine, Tofogliflozin added to insulin, and insulin dose-increase therapy in uncontrolled type 2 diabetes. J Clin Med Res. 2016;8:805-814.
32. 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;97:1020-1031.
33. Kato M, Yamashita S, Tsutsui K, Kato N. Tofogliflozin add-on therapy to insulin for poorly controlled Japanese, obese, type 2 diabetic patients. Prog Med. 2015;35:1067-1075.
34. Al-Goblan AS, Al-Alfi MA, Khan MZ. Mechanism linking diabetes mellitus and obesity. Diabetes Metab Syndr Obes. 2014;7:587-591.
35. Yki-Järvinen H. Combination therapies with insulin in type 2 diabetes. Diabetes Care. 2001;24:758-767.