Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise

Diabetes, Obesity and Metabolism

Volumn 15, Issue 4, 2013, Pages 372-382

  Stenlof K ^a   Cefalu, W T ^b,c   Kim, K A ^d   Alba, M ^e   Usiskin, K ^e   Tong, C ^e   Canovatchel, W ^e   Meininger, G ^e  

^a SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^b PENNINGTON BIOMEDICAL RESEARCH CENTER   (United States)

^c LOUISIANA STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d Dongguk University Ilsan Hospital   (South Korea)

^e JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Phase 3 study; SGLT2 inhibitor; Type 2 diabetes

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTIFUNGAL AGENT; CANAGLIFLOZIN; CREATININE; GLUCOSE; HEMOGLOBIN; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; NITROGEN; PLACEBO; PROINSULIN; TRIACYLGLYCEROL; URATE; UREA;

ADULT; ARTICLE; BALANITIS; BALANITIS CANDIDA; BALANOPOSPHITIS; CELL FUNCTION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIABETIC DIET; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FEMALE GENITAL TRACT INFECTION; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; KINESIOTHERAPY; MAJOR CLINICAL STUDY; MALE; MALE GENITAL TRACT INFECTION; MONOTHERAPY; MYCOSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; ORTHOSTATIC HYPOTENSION; PANCREAS ISLET BETA CELL; PHASE 3 CLINICAL TRIAL; POLLAKISURIA; POLYURIA; POSITIONAL DIZZINESS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; TREATMENT FAILURE; TREATMENT OUTCOME; UREA NITROGEN BLOOD LEVEL; URIC ACID BLOOD LEVEL; URINARY FREQUENCY; URINARY TRACT INFECTION; URINE VOLUME; VAGINA CANDIDIASIS; VAGINITIS; VULVITIS; VULVOVAGINAL MYCOTIC INFECTION; VULVOVAGINITIS; WEIGHT CHANGE;

EID: 84874291673     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12054     Document Type: Article

References (22)

1. Inzucchi S.E., Bergenstal R.M., Buse J.B. et al. 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: 1364-1379.
2. Cook M.N., Girman C.J., Stein P.P., Alexander C.M., Holman R.R. Glycemic control continues to deteriorate after sulfonylureas are added to metformin among patients with type 2 diabetes. Diabetes Care 2005; 28: 995-1000.
3. Cook M.N., Girman C.J., Stein P.P., Alexander C.M. Initial monotherapy with either metformin or sulphonylureas often fails to achieve or maintain current glycaemic goals in patients with Type 2 diabetes in UK primary care. Diabet Med 2007; 24: 350-358.
4. Standl E. The importance of beta-cell management in type 2 diabetes. Int J Clin Pract Suppl 2007; 153: 10-19.
5. Bennett W.L., Maruthur N.M., Singh S. et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med 2011; 154: 602-613.
6. Neumiller J.J., White J.R. Jr., Campbell R.K. Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs 2010; 70: 377-385.
7. Defronzo R.A. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes 2009; 58: 773-795.
8. Devineni D., Morrow L., Hompesch M. et al. Canagliflozin improves glycemic control over 28days in subjects with type 2 diabetes not optimally controlled on insulin. Diabetes Obes Metab 2012; 14: 539-545.
9. Liang Y., Arakawa K., Ueta K. et al. Effect of canagliflozin on renal threshold for glucose, glycemia, and body weight in normal and diabetic animal models. PLoS One 2012; 7: e30555.
10. 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: 6355-6360.
11. 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: 1232-1238.
12. 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: 669-672.
13. Inagaki N., Kondo K., Iwasaki T. et al. Canagliflozin, a novel inhibitor of sodium glucose co-transporter 2 (SGLT2) improves glycemic control and reduces body weight in Japanese type 2 diabetes mellitus (T2DM) (Abstract 0999-P). Diabetes 2011; 60(Suppl. 1): A274.
14. Polidori D., Sha S., Mudaliar S. et al. Canagliflozin lowers postprandial glucose and insulin by delaying intestinal glucose absorption in addition to increasing urinary glucose excretion (Abstract 79-OR). Diabetes 2012; 61(Suppl. 1): A22.
15. Stein P., Berg J.K., Morrow L. et al. Canagliflozin (CANA), a sodium glucose co-transporter 2 (SGLT2) inhibitor, reduces post-meal glucose excursion in patients with type 2 diabetes mellitus (T2DM) by a non-renal mechanism (Abstract 84-OR). Diabetes 2012; 61(Suppl. 1): A24.
16. Klein S., Sheard N.F., Pi-Sunyer X. et al. Weight management through lifestyle modification for the prevention and management of type 2 diabetes: rationale and strategies: a statement of the American Diabetes Association, the North American Association for the Study of Obesity, and the American Society for Clinical Nutrition. Diabetes Care 2004; 27: 2067-2073.
17. Diabetes Prevention Program Research Group. Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study. Diabetes Care 2012; 35: 731-737.
18. Polidori D., Zhao Y., Sha S., Canovatchel W. Canagliflozin treatment improves beta cell function in subjects with type 2 diabetes (Abstract 646-P). Diabetes 2010; 59(Suppl. 1).
19. Wajchenberg B.L. Clinical approaches to preserve beta-cell function in diabetes. Adv Exp Med Biol 2010; 654: 515-535.
20. Nicolle L.E., 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: 1167-1171.
21. 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 co-transporter 2 inhibitor. Curr Med Res Opin 2012; 28: 1173-1178.
22. Ferrannini E., Ramos S.J., Salsali A., Tang W., List J.F. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 2010; 33: 2217-2224.