Efficacy and safety of canagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled with diet and exercise: A 24-week, randomized, double-blind, placebo-controlled, Phase III study

Expert Opinion on Pharmacotherapy

Volumn 15, Issue 11, 2014, Pages 1501-1515

  Inagaki, Nobuya ^a   Kondo, Kazuoki ^b   Yoshinari, Toru ^b   Takahashi, Nahoko ^b   Susuta, Yutaka ^b   Kuki, Hideki ^b  

^a KYOTO UNIVERSITY   (Japan)

^b MITSUBISHI TANABE PHARMA CORPORATION   (Japan)

Author keywords

Canagliflozin; Hemoglobin A1c; Sodium glucose co transporter 2 inhibitor; Type 2 diabetes

Indexed keywords

ALANINE AMINOTRANSFERASE; CANAGLIFLOZIN; CREATININE; GAMMA GLUTAMYLTRANSFERASE; GLUCOSE; HEMOGLOBIN A1C; KETONE BODY; PLACEBO; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; GLUCOSIDE; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; LIPID; THIOPHENE DERIVATIVE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIET; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXERCISE; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GENITAL TRACT INFECTION; GLUCOSE BLOOD LEVEL; GLUCOSE TOLERANCE TEST; GLYCEMIC CONTROL; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; UREA NITROGEN BLOOD LEVEL; URINARY TRACT INFECTION; AGED; BLOOD; BLOOD PRESSURE; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DIET THERAPY; DRUG EFFECTS; JAPAN; KINESIOTHERAPY; METABOLISM; MIDDLE AGED; WEIGHT REDUCTION;

AGED; BLOOD GLUCOSE; BLOOD PRESSURE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; EXERCISE THERAPY; FEMALE; GLUCOSIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; JAPAN; KETONE BODIES; LIPIDS; MALE; MIDDLE AGED; THIOPHENES; TREATMENT OUTCOME; WEIGHT LOSS;

EID: 84904207974     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2014.935764     Document Type: Article

References (37)

1. Rave K, Nosek L, Posner J, et al. Renal glucose excretion as a function of blood glucose concentration in subjects with type 2 diabetes-results of a hyperglycaemic glucose clamp study. Nephrol Dial Transplant 2006;21:2166-71
2. Ruhnau B, Faber OK, Borch-Johnsen K, Thorsteinsson B. Renal threshold for glucose in non-insulin-dependent diabetic patients. Diabetes Res Clin Pract 1997;36:27-33
3. Nair S, Wilding JP. Sodium glucose cotransporter 2 inhibitors as a new treatment for diabetes mellitus. J Clin Endocrinol Metab 2010;95:34-42
4. Rahmoune H, Thompson PW, Ward JM, et al. Glucose transporters in human renal proximal tubular cells isolated from the urine of patients with non-insulin-dependent diabetes. Diabetes 2005;54:3427-34
5. Jurczak MJ, Lee HY, Birkenfeld AL, et al. SGLT2 deletion improves glucose homeostasis and preserves pancreatic beta-cell function. Diabetes 2011;60:890-8
6. List JF, Whaley JM. Glucose dynamics and mechanistic implications of SGLT2 inhibitors in animals and humans. Kidney Int Suppl 2011;S20-7
7. You G, Lee WS, Barros EJ, et al. Molecular characteristics of Na(+)-coupled glucose transporters in adult and embryonic rat kidney. J Biol Chem 1995;270:29365-71
8. Santer R, Calado J. Familial renal glucosuria and SGLT2: from a mendelian trait to a therapeutic target. Clin J Am Soc Nephrol 2010;5:133-41
9. Polidori D, Sha S, Devineni D, Rothenberg P. The renal glucose threshold is increased in patients with type 2 diabetes: results from a novel method for measuring the renal threshold (abstract 2186-PO). 70th Scientific Sessions of the American Diabetes Association; Orlando, FL, USA; 2010
10. Abdul-Ghani MA, DeFronzo RA. Inhibition of renal glucose reabsorption: a novel strategy for achieving glucose control in type 2 diabetes mellitus. Endocr Pract 2008;14:782-90
11. 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
12. Adachi T, Yasuda K, Okamoto Y, et al. T-1095, a renal Na+-glucose transporter inhibitor, improves hyperglycemia in streptozotocin-induced diabetic rats. Metabolism 2000;49:990-5
13. Luippold G, Klein T, Mark M, Grempler R. Empagliflozin, a novel potent and selective SGLT-2 inhibitor, improves glycaemic control alone and in combination with insulin in streptozotocin-induced diabetic rats, a model of type 1 diabetes mellitus. Diabetes Obes Metab 2012;14:601-7
14. Wilding JP, Norwood P, T'Joen C, et al. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulinindependent treatment. Diabetes Care 2009;32:1656-62
15. Chen LH, Leung PS. Inhibition of the sodium glucose co-transporter-2: its beneficial action and potential combination therapy for type 2 diabetes mellitus. Diabetes Obes Metab 2013;15:392-402
16. Nomura S, Sakamaki S, Hongu M, et al. Discovery of canagliflozin, a novel C-glucoside with thiophene ring, as sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes mellitus. J Med Chem 2010;53:6355-60
17. Liang Y, Arakawa K, Ueta K, et al. Effect of canagliflozin on renal threshold for glucose, glycemia, and bodyweight in normal and diabetic animal models. PLoS One 2012;7:e30555
18. Liang Y, Du F, Conway JG, et al. Mechanism of action: canagliflozin, an SGLT2 inhibitor, increases urinary glucose excretion (UGE) in ZDF rats by lowering the renal glucose threshold (RTG) (abstract 1090-P). 71st Scientific Sessions of the American Diabetes Association; San Diego, CA, USA; 2011
19. Sha S, Devineni D, Ghosh A, et al. Canagliflozin, a novel inhibitor of sodium glucose co-transporter 2, dose dependently reduces calculated renal threshold for glucose excretion and increases urinary glucose excretion in healthy subjects. Diabetes Obes Metab 2011;13:669-72
20. Devineni D, Curtin CR, Polidori D, et al. Pharmacokinetics and pharmacodynamics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in subjects with type 2 diabetes mellitus. J Clin Pharmacol 2013;53:601-10.
21. 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
22. 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
23. Stenlof 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;15:372-82.
24. Inagaki N, Kondo K, Yoshinari T, et al. Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebocontrolled, 12-week study. Diabetes Obes Metab 2013;15:1136-45.
25. Cefalu WT, Leiter LA, Yoon KH, et al. 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;382:941-50
26. 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;36:2508-15
27. Elkinson S, Scott LJ. Canagliflozin: first global approval. Drugs 2013;73:979-88
28. Kashiwagi A, Kasuga M, Araki E, et al. International clinical harmonization of glycated hemoglobin in Japan: from Japan Diabetes Society to National Glycohemoglobin Standardization Program values. Diabetol Int 2012;3:8-10
29. Nyamdorj R, Pitkaniemi J, Tuomilehto J, et al. Ethnic comparison of the association of undiagnosed diabetes with obesity. Int J Obes (Lond) 2010;34:332-9
30. Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet 2005;365:1333-46
31. Campbell IW. Comparing the actions of older and newer therapies on bodyweight: to what extent should these effects guide the selection of antidiabetic therapy? Int J Clin Pract 2010;64:791-801
32. Morgan CL, Jenkins-Jones S, Evans M, et al. Weight change in people with type 2 diabetes: secular trends and the impact of alternative antihyperglycaemic drugs. Diabetes Obes Metab 2012;14:424-32
33. Meneghini LF, Orozco-Beltran D, Khunti K, et al. Weight beneficial treatments for type 2 diabetes. J Clin Endocrinol Metab 2011;96:3337-53
34. Nicolle LE, Capuano G, Ways K, Usiskin K. Effect of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enrolled in a 12-week, phase 2 study. Curr Med Res Opin 2012;28:1167-71
35. Nyirjesy P, Zhao Y, Ways K, Usiskin K. Evaluation of vulvovaginal symptoms and Candida colonization in women with type 2 diabetes mellitus treated with canagliflozin, a sodium glucose cotransporter 2 inhibitor. Curr Med Res Opin 2012;28:1173-8
36. Neal B, Perkovic V, de Zeeuw D, et al. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)-a randomized placebocontrolled trial. Am Heart J 2013;166:217-23.e11
37. Evaluation of the effects of canagliflozin on renal and cardiovascular outcomes in participants with diabetic nephropathy (CREDENCE) (NCT02065791). Available from: www.clinicaltrials.gov/ct2/show/NCT02065791 [Last accessed 10 June 2014]