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

Diabetology International

Volumn 6, Issue 2, 2015, Pages 125-138

  Kashiwagi, Atsunori ^a   Akiyama, Noriko ^b   Shiga, Takanori ^b   Kazuta, Kenichi ^b   Utsuno, Atsushi ^b   Yoshida, Satoshi ^b   Ueyama, Eiji ^b  

^a SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^b ASTELLAS PHARMA INC   (Japan)

Author keywords

Ipragliflozin; Japanese patients; Randomized controlled trial; SGLT2; Sulfonylurea; Type 2 diabetes

Indexed keywords

ANTIDIABETIC AGENT; CORTICOSTEROID; GLIBENCLAMIDE; GLICLAZIDE; GLIMEPIRIDE; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; IMMUNOSUPPRESSIVE AGENT; INSULIN; IPRAGLIFLOZIN; LOOP DIURETIC AGENT; MAGNESIUM; PHOSPHATE; PLACEBO; SULFONYLUREA; TRIACYLGLYCEROL;

ADD ON THERAPY; ADULT; AGED; ARTICLE; BODY WEIGHT; BRAIN INFARCTION; CHOLESTEROL BLOOD LEVEL; CLINICAL OBSERVATION; CONSTIPATION; CONTROLLED STUDY; DIABETES CONTROL; DIABETIC PATIENT; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GENITAL TRACT INFECTION; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERKERATOSIS; HYPERTENSION; HYPOGLYCEMIA; INSULIN TREATMENT; JAPANESE (PEOPLE); LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MIDDLE AGED; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; OSTEOMYELITIS; PARKINSON DISEASE; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; PHOSPHATE URINE LEVEL; POLLAKISURIA; POLYDIPSIA; POLYURIA; PRESCRIPTION; PRIORITY JOURNAL; PROLIFERATIVE RETINOPATHY; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SKIN ABSCESS; STOMACH POLYP; STOMATITIS; THIRST; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL; UREA NITROGEN BLOOD LEVEL; URINARY TRACT INFECTION;

EID: 84930684161     PISSN: 21901678     EISSN: 21901686     Source Type: Journal    
DOI: 10.1007/s13340-014-0184-9     Document Type: Article

References (24)

1. Sabolić I, Vrhovac I, Eror DB, Gerasimova M, Rose M, Breljak D, Ljubojević M, Brzica H, Sebastiani A, Thal SC, Sauvant C, Kipp H, Vallon V, Koepsell H. Expression of Na+-d-glucose cotransporter SGLT2 in rodents is kidney-specific and exhibits sex and species differences. Am J Physiol Cell Physiol. 2012;302:C1174–88.
2. Bakris GL, Fonseca VA, Sharma K, Wright EM. Renal sodium-glucose transport: role in diabetes mellitus and potential clinical implications. Kidney Int. 2009;75:1272–7.
3. Wright EM. Renal Na+-glucose cotransporters. Am J Physiol Renal Physiol. 2001;280:F10–8.
4. Nair S, Wilding JP. Sodium glucose cotransporter 2 inhibitors as a new treatment for diabetes mellitus. J Clin Endocrinol Metab. 2010;95:34–42.
5. Neumiller JJ, White JR Jr, Campbell RK. Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs. 2010;70:377–85.
6. Veltkamp SA, Kadokura T, Krauwinkel WJ, Smulders RA. Effect of ipragliflozin (ASP1941), a novel selective sodium-dependent glucose co-transporter 2 inhibitor, on urinary glucose excretion in healthy subjects. Clin Drug Investig. 2011;31:839–51.
7. Kadokura T, Saito M, Utsuno A, Kazuta K, Yoshida S, Kawasaki S, Nagase I, Kageyama S. Ipragliflozin (ASP1941), a selective sodium-dependent glucose cotransporter 2 inhibitor, safely stimulates urinary glucose excretion without inducing hypoglycemia in healthy Japanese subjects. Diabetol Int. 2011;2:172–82.
8. Schwartz SL, Akinlade B, Klasen S, Kowalski D, Zhang W, Wilpshaar W. Safety, pharmacokinetic, and pharmacodynamic profiles of ipragliflozin (ASP1941), a novel and selective inhibitor of sodium-dependent glucose co-transporter 2, in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2011;13:1219–27.
9. Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complicat. 2013;27:268–73.
10. Kashiwagi A, Kazuta K, Yoshida S, Nagase I. 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. 2013. doi:10.1111/jdi.12156.
11. Wilding JP, Ferrannini E, Fonseca VA, Wilpshaar W, Dhanjal P, Houzer A. Efficacy and safety of ipragliflozin in patients with type 2 diabetes inadequately controlled on metformin: a dose-finding study. Diabetes Obes Metab. 2013;15:403–9.
12. Arai K, Matoba K, Hirao K, Matsuba I, Takai M, Takeda H, Kanamori A, Yamauchi M, Mori H, Terauchi Y. Present status of sulfonylurea treatment for type 2 diabetes in Japan: second report of a cross-sectional survey of 15,652 patients. Endocr J. 2010;57:499–507.
13. Pan C, Yang W, Jia W, Weng J, Tian H. Management of Chinese patients with type 2 diabetes, 1998–2006: the Diabcare-China surveys. Curr Med Res Opin. 2009;25:39–45.
14. Smulders RA, Zhang W, Veltkamp SA, van Dijk J, Krauwinkel WJ, Keirns J, Kadokura T. No pharmacokinetic interaction between ipragliflozin and sitagliptin, pioglitazone, or glimepiride in healthy subjects. Diabetes Obes Metab. 2012;14:937–43.
15. Kashiwagi A, Kasuga M, Araki E, Oka Y, Hanafusa T, Ito H, Tominaga M, Oikawa S, Noda M, Kawamura T, Sanke T, Namba M, Hashiramoto M, Sasahara T, Nishio Y, Kuwa K, Ueki K, Takei I, Umemoto M, Murakami M, Yamakado M, Yatomi Y, Ohashi H. International clinical harmonization of glycated hemoglobin in Japan: from Japan Diabetes Society to National Glycohemoglobin Standardization Program values. Diabetol Int. 2012;3:8–10.
16. Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, Yamagata K, Tomino Y, Yokoyama H, Hishida A. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009;53:982–92.
17. Director, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Guideline for clinical evaluation of oral hypoglycemic agents. Tokyo: Ministry of Health, Labour and Welfare; 2010.
18. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28:412–9.
19. Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O’Neill MC, Zinman B, Viberti G. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355:2427–43.
20. Tan MH, Baksi A, Krahulec B, Kubalski P, Stankiewicz A, Urquhart R, Edwards G, Johns D, GLAL Study Group. Comparison of pioglitazone and gliclazide in sustaining glycemic control over 2 years in patients with type 2 diabetes. Diabetes Care. 2005;28:544–50.
21. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. 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;35:1364–79.
22. Bolinder J, Ljunggren Ö, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. 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;97:1020–31.
23. Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011;13:928–38.
24. Jurczak MJ, Lee HY, Birkenfeld AL, Jornayvaz FR, Frederick DW, Pongratz RL, Zhao X, Moeckel GW, Samuel VT, Whaley JM, Shulman GI, Kibbey RG. SGLT2 deletion improves glucose homeostasis and preserves pancreatic beta-cell function. Diabetes. 2011;60:890–8.