Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, 12-week study

Diabetes, Obesity and Metabolism

Volumn 15, Issue 12, 2013, Pages 1136-1145

  Inagaki, N ^a   Kondo, K ^b   Yoshinari, T ^b   Maruyama, N ^b   Susuta, Y ^b   Kuki, H ^b  

^a KYOTO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b MITSUBISHI TANABE PHARMA CORPORATION   (Japan)

Author keywords

SGLT2 inhibitor

Indexed keywords

CANAGLIFLOZIN; CREATININE; GLUCOSE; HEMOGLOBIN A1C; KETONE BODY; PLACEBO;

ADULT; AGED; ARTICLE; BLOOD CHEMISTRY; BODY WEIGHT; CANDIDIASIS; CLINICAL LABORATORY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE URINE LEVEL; DEHYDRATION; DIET THERAPY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATTY ACID BLOOD LEVEL; FEMALE; FOLLOW UP; GASTRITIS; GLUCOSE BLOOD LEVEL; GLUCOSE URINE LEVEL; GLYCEMIC CONTROL; HEART PALPITATION; HUMAN; HYPOGLYCEMIA; JAPANESE; KINESIOTHERAPY; LABORATORY TEST; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALAISE; MALE; MOUTH DISCOMFORT; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT COMPLIANCE; PERIODONTITIS; POLLAKISURIA; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RISK ASSESSMENT; SIDE EFFECT; TEST MEAL; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINALYSIS; XEROSTOMIA;

SGLT2 INHIBITOR;

ADULT; AGED; AGED, 80 AND OVER; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GLUCOSIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; THIOPHENES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84887147788     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12149     Document Type: Article

References (23)

1. International Diabetes Federation. IDF Diabetes Atlas. 5th edn. Brussels, Belgium: International Diabetes Federation, 2011.
2. American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care 2012; 35(Suppl 1): S11-63.
3. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193-203.
4. Kahn SE, Haffner SM, Heise MA et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006; 355: 2427-2443.
5. Rave K, Nosek L, Posner J, Heise T, Roggen K, van Hoogdalem EJ. 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: 2166-2171.
6. 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.
7. Nair S, Wilding JP. Sodium glucose cotransporter 2 inhibitors as a new treatment for diabetes mellitus. J Clin Endocrinol Metab 2010; 95: 34-42.
8. Rahmoune H, Thompson PW, Ward JM, Smith CD, Hong G, Brown J. Glucose transporters in human renal proximal tubular cells isolated from the urine of patients with non-insulin-dependent diabetes. Diabetes 2005; 54: 3427-3434.
9. 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: 782-790.
10. 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.
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. 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.
13. 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.
14. Devineni D, Morrow L, Hompesch M et al. Canagliflozin improves glycaemic control over 28days in subjects with type 2 diabetes not optimally controlled on insulin. Diabetes Obes Metab 2012; 14: 539-545.
15. 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.
16. 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: 372-382.
17. List JF, Woo V, Morales E, Tang W, Fiedorek FT. Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes Care 2009; 32: 650-657.
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 2009; 32: 1656-1662.
19. Kaku K, Inoue S, Matsuoka O et al. 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; 15: 432-440.
20. 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. 70th Scientific Sessions of the American Diabetes Association (Abstract 2186-PO). Orlando, FL, USA, 2010.
21. Liang Y, Du F, Conway JG, Polidori D, Clapper J, Demarest K. Mechanism of action: canagliflozin, an SGLT2 inhibitor, increases urinary glucose excretion (UGE) in ZDF rats by lowering the renal glucose threshold (RTG). 71st Scientific Sessions of the American Diabetes Association (Abstract 1090-P). San Diego, CA, USA, 2011.
22. Polidori D, Sakai M, Devineni D. Exposure-response modeling of canagliflozin effects on the renal glucose threshold in subjects with type 2 diabetes (T2DM). 71st Scientific Sessions of the American Diabetes Association (Abstract 1072-P). San Diego, CA, USA, 2011.
23. Jurczak MJ, Lee HY, Birkenfeld AL et al. SGLT2 deletion improves glucose homeostasis and preserves pancreatic beta-cell function. Diabetes 2011; 60: 890-898.