Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index: A subgroup analysis of five randomized clinical trials

Journal of Diabetes Investigation

Volumn 7, Issue 4, 2016, Pages 544-554

  Kashiwagi, Atsunori ^a   Yoshida, Satoshi ^b   Nakamura, Ichiro ^b   Kazuta, Kenichi ^b   Ueyama, Eiji ^b   Takahashi, Hideyuki ^b   Satomi, Hayato ^b   Kosakai, Yoshinori ^b   Kawamuki, Kosei ^b  

^a Kusatsu General Hospital   (Japan)

^b ASTELLAS PHARMA INC   (Japan)

Author keywords

Body mass index; Ipragliflozin; Sodium glucose co transporter 2

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BETA 2 MICROGLOBULIN; BIGUANIDE; GAMMA GLUTAMYLTRANSFERASE; GLITAZONE DERIVATIVE; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; IPRAGLIFLOZIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METFORMIN; NITROGEN; PIOGLITAZONE; PLACEBO; SULFONYLUREA; TRIACYLGLYCEROL; UREA; URIC ACID;

ADULT; ARTICLE; BODY MASS; BODY WEIGHT; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DISEASE DURATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEMALE GENITAL TRACT INFECTION; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMATOCRIT; HUMAN; HYPERTENSION; HYPOGLYCEMIA; HYPOTENSION; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MALE GENITAL TRACT INFECTION; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; POLLAKISURIA; POLYDIPSIA; POLYURIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SMOKING; SYSTOLIC BLOOD PRESSURE; UREA NITROGEN BLOOD LEVEL; URINARY TRACT INFECTION; WAIST CIRCUMFERENCE;

EID: 84977572114     PISSN: 20401116     EISSN: 20401124     Source Type: Journal    
DOI: 10.1111/jdi.12471     Document Type: Article

References (23)

1. Kashiwagi A, Kazuta K, Yoshida S, et al. 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 Investig 2014; 5: 382–391.
2. Kashiwagi A, Kazuta K, Takinami Y, et al. Ipragliflozin improves glycemic control in Japanese patients with type 2 diabetes mellitus: the BRIGHTEN study. Diabetol Int 2015; 6: 8–18.
3. Kashiwagi A, Kazuta K, Goto K, et al. Ipragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes: ILLUMINATE, a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab 2015; 17: 304–308.
4. Kashiwagi A, Shiga T, Akiyama N, et al. Efficacy and safety of ipragliflozin as an add-on to pioglitazone in Japanese patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebo-controlled study (the SPOTLIGHT study). Diabetol Int 2015; 6: 104–116.
5. Kashiwagi A, Akiyama N, Shiga T, et al. Efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese patients with inadequately controlled type 2 diabetes: results of the randomized, placebo-controlled, double-blind, phase III EMIT study. Diabetol Int 2015; 6: 125–138.
6. 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. J Diabetes Investig 2012; 3: 39–40.
7. International Federation of Clinical Chemistry (IFCC). Harmonizing Hemoglobin A1c Testing: Standardization of HbA1c. Available from: http://www.ngsp.org/docs/IFCCstd.pdf. Accessed November 3, 2014.
8. Liakos A, Karagiannis T, Athanasiadou E, et al. Efficacy and safety of empagliflozin for type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes Metab 2014; 16: 984–993.
9. Sun YN, Zhou Y, Chen X, et al. The efficacy of dapagliflozin combined with hypoglycaemic drugs in treating type 2 diabetes mellitus: meta-analysis of randomised controlled trials. BMJ Open 2014; 4: e004619.
10. Zhang M, Zhang L, Wu B, et al. Dapagliflozin treatment for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Metab Res Rev 2014; 30: 204–221.
11. Sinclair A, Bode B, Harris S, et al. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord 2014; 14: 37.
12. Wilding JP, Ferrannini E, Fonseca VA, et al. Efficacy and safety of ipragliflozin in patients with type 2 diabetes inadequately controlled on metformin: a dose-finding study. Diabetes Obes Metab 2013; 15: 403–409.
13. Usiskin K, Kline I, Fung A, et al. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med 2014; 126: 16–34.
14. Ptaszynska A, Johnsson KM, Parikh SJ, et al. Safety profile of dapagliflozin for type 2 diabetes: pooled analysis of clinical studies for overall safety and rare events. Drug Saf 2014; 37: 815–829.
15. Nicolle LE, Capuano G, Fung A, et al. Urinary tract infection in randomized phase III studies of canagliflozin, a sodium glucose co-transporter 2 inhibitor. Postgrad Med 2014; 126: 7–17.
16. 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.
17. Yokono M, Takasu T, Hayashizaki Y, et al. SGLT2 selective inhibitor ipragliflozin reduces body fat mass by increasing fatty acid oxidation in high-fat diet-induced obese rats. Eur J Pharmacol 2014; 727: 66–74.
18. Sha S, Polidori D, Heise T, et al. Effect of the sodium glucose co-transporter 2 inhibitor canagliflozin on plasma volume in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2014; 16: 1087–1095.
19. Oliva RV, Bakris GL. Blood pressure effects of sodium-glucose co-transport 2 (SGLT2) inhibitors. J Am Soc Hypertens 2014; 8: 330–339.
20. Nicolle LE, Capuano G, Ways K, et al. 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, et al. 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. Johnsson KM, Ptaszynska A, Schmitz B, et al. Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complications 2013; 27: 479–484.
23. Yoshiike N, Miyoshi M. [Epidemiological aspects of overweight and obesity in Japan–international comparisons]. Nihon Rinsho 2013; 71: 207–216.