Dapagliflozin's effects on glycemia and cardiovascular risk factors in high-risk patients with type 2 diabetes: A 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension

Diabetes Care

Volumn 38, Issue 7, 2015, Pages 1218-1227

  Cefalu, William T ^a   Leiter, Lawrence A ^b   De Bruin, Tjerk W A ^c   Gause Nilsson, Ingrid ^d   Sugg, Jennifer ^c   Parikh, Shamik J ^c  

^a PENNINGTON BIOMEDICAL RESEARCH CENTER   (United States)

^b ST MICHAEL'S HOSPITAL   (Canada)

^c ASTRAZENECA   (United Kingdom)

^d ASTRAZENECA R AND D   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

DAPAGLIFLOZIN; ELECTROLYTE; GLUCOSE; HEMOGLOBIN A1C; INSULIN; LIVER ENZYME; PLACEBO; 2-(3-(4-ETHOXYBENZYL)-4-CHLOROPHENYL)-6-HYDROXYMETHYLTETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; GLUCOSE BLOOD LEVEL; GLUCOSIDE; GLYCOSYLATED HEMOGLOBIN;

ADULT; AGE; AGED; ARTICLE; CARDIOGENIC SHOCK; CARDIOVASCULAR RISK; CAUSE OF DEATH; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DEHYDRATION; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FUNGAL GENITAL INFECTION; GLUCOSE BLOOD LEVEL; HEART DISEASE; HEART INFARCTION; HIGH RISK PATIENT; HUMAN; HYPERTENSION; HYPOGLYCEMIA; HYPOTENSION; HYPOVOLEMIA; KIDNEY FAILURE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MEDICAL HISTORY; MULTICENTER STUDY; MULTIPLE ORGAN FAILURE; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SEPTIC SHOCK; SUDDEN DEATH; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; URINARY TRACT INFECTION; WEIGHT REDUCTION; ANALYSIS OF VARIANCE; BLOOD PRESSURE; BODY WEIGHT; CHEMICALLY INDUCED; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DIABETIC ANGIOPATHIES; DRUG EFFECTS; FEMALE; MALE; MIDDLE AGED; RISK FACTOR;

ANALYSIS OF VARIANCE; BENZHYDRYL COMPOUNDS; BLOOD GLUCOSE; BLOOD PRESSURE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DIABETIC ANGIOPATHIES; DOUBLE-BLIND METHOD; FEMALE; GLUCOSIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MIDDLE AGED; RISK FACTORS; TREATMENT OUTCOME; URINARY TRACT INFECTIONS;

EID: 84945175811     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc14-0315     Document Type: Article

References (27)

1. American Diabetes Association. Standards of medical care in diabetes - 2013. Diabetes Care 2013;36(Suppl. 1):S11-S66
2. Rodbard HW, Blonde L, Braithwaite SS, et al, .; AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract 2007;13(Suppl. 1):1-68
3. Inzucchi SE, Bergenstal RM, Buse JB, et al, .; American Diabetes Association (ADA), ; European Association for the Study of Diabetes (EASD). 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
4. Rydén L, Grant PJ, Anker SD, et al, .; Authors/Task Force Members, ; ESC Committee for Practice Guidelines (CPG). ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on Diabetes, Pre-diabetes, and Cardiovascular Diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J 2013;34:3035-3087
5. Cheung BM, Ong KL, Cherny SS, Sham PC, Tso AW, Lam KS. Diabetes prevalence and therapeutic target achievement in the United States, 1999 to 2006. Am J Med 2009;122:443-453
6. Dodd AH, Colby MS, Boye KS, Fahlman C, Kim S, Briefel RR. Treatment approach and HbA1c control among US adults with type 2 diabetes: NHANES 1999-2004. Curr Med Res Opin 2009;25:1605-1613
7. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet 2010;375:2223-2233
8. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. 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
9. 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
10. Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care 2011;34:2015-2022
11. 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;13:928-938
12. 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
13. Tsiatis AA, Davidian M, Zhang M, Lu X. Covariate adjustment for two-sample treatment comparisons in randomized clinical trials: a principled yet flexible approach. Stat Med 2008;27:4658-4677
14. Zhang L, Feng Y, List J, Kasichayanula S, Pfister M. Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight. Diabetes Obes Metab 2010;12:510-516
15. Leiter LA, Cefalu WT, de Bruin TWA, Gause-Nilsson I, Sugg J, Parikh SJ. Dapagliflozin added to usual care in individuals with type 2 diabetes mellitus with preexisting cardiovascular disease: a 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension. J Am Geriatr Soc 2014;62:1252-1262
16. Kasichayanula S, Liu X, Pe Benito M, et al. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol 2013;76:432-444
17. Horton ES, Silberman C, Davis KL, Berria R. Weight loss, glycemic control, and changes in cardiovascular biomarkers in patients with type 2 diabetes receiving incretin therapies or insulin in a large cohort database. Diabetes Care 2010;33:1759-1765
18. Norris SL, Zhang X, Avenell A, et al. Efficacy of pharmacotherapy for weight loss in adults with type 2 diabetes mellitus: a meta-analysis. Arch Intern Med 2004;164:1395-1404
19. Turnbull F; Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials. Lancet 2003;362:1527-1535
20. Whelton PK, He J, Appel LJ, et al, .; National High Blood Pressure Education Program Coordinating Committee. Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. JAMA 2002;288:1882-1888
21. Jabbour SA, Whaley JM, Tirmenstein M, et al. Targeting renal glucose reabsorption for the treatment of type 2 diabetes mellitus using the SGLT2 inhibitor dapagliflozin. Postgrad Med 2012;124:62-73
22. Geerlings S, Fonseca V, Castro-Diaz D, List J, Parikh S. Genital and urinary tract infections in diabetes: impact of pharmacologically-induced glucosuria. Diabetes Res Clin Pract 2014;103:373-381
23. Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complications 2013;27:479-484
24. Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Urinary tract infections in patients with diabetes treated with dapagliflozin. J Diabetes Complications 2013;27:473-478
25. Berlin JA, Glasser SC, Ellenberg SS. Adverse event detection in drug development: recommendations and obligations beyond phase 3. Am J Public Health 2008;98:1366-1371
26. Ptaszynska A, Johnsson KM, Parikh SJ, de Bruin TW, Apanovitch AM, List JF. 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
27. Hasan FM, Alsahli M, Gerich JE. SGLT2 inhibitors in the treatment of type 2 diabetes. Diabetes Res Clin Pract 2014;104:297-322