Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency

Diabetes, Obesity and Metabolism

Volumn 10, Issue 7, 2008, Pages 545-555

  Chan, J C N ^a   Scott, R ^b   Arjona Ferreira, J C ^c   Sheng, D ^c   Gonzalez, E ^c   Davies, M J ^c   Stein, P P ^c   Kaufman, K D ^c   Amatruda, J M ^c   Williams Herman, Debora ^c  

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^b CHRISTCHURCH HOSPITAL   (New Zealand)

^c MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Chronic kidney disease; DPP 4 inhibitor; MK 0431; Type 2 diabetes

Indexed keywords

ANALGESIC AGENT; ANTIDIABETIC AGENT; ANTILIPEMIC AGENT; DIURETIC AGENT; GLIPIZIDE; HEMOGLOBIN A1C; INSULIN; PLACEBO; SITAGLIPTIN; SULFONYLUREA;

ACUTE HEART INFARCTION; ADULT; AGED; ANEMIA; ARTHRITIS; ARTICLE; ATHEROSCLEROSIS; BACKACHE; BENIGN TUMOR; BLOOD DISEASE; BREAST DISEASE; CATHETER INFECTION; CHRONIC KIDNEY FAILURE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONNECTIVE TISSUE DISEASE; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY ATHEROSCLEROSIS; CORONARY ARTERY DISEASE; COUGHING; CREATININE CLEARANCE; DIALYSIS; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EAR DISEASE; ENDOCRINE DISEASE; EYE DISEASE; FALLING; FEMALE; GASTROENTERITIS; GASTROESOPHAGEAL REFLUX; GENITAL SYSTEM DISEASE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEART ATRIUM FIBRILLATION; HEART DISEASE; HEART FAILURE; HEART INFARCTION; HEMOGLOBIN DETERMINATION; HEPATOBILIARY DISEASE; HUMAN; HYPERTENSION; HYPOGLYCEMIA; IMMUNOPATHOLOGY; INCIDENCE; INFECTION; INFESTATION; INNER EAR DISEASE; KIDNEY DISEASE; LETHARGY; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MEDIASTINUM DISEASE; MENTAL DISEASE; METABOLIC DISORDER; MONOTHERAPY; MORTALITY; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; NON INSULIN DEPENDENT DIABETES MELLITUS; NUTRITIONAL DISORDER; PERIPHERAL EDEMA; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; SHOULDER PAIN; SIDE EFFECT; STAPHYLOCOCCUS INFECTION; THORAX DISEASE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT DISEASE; URINARY TRACT INFECTION; VASCULAR DISEASE;

EID: 45449105789     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2008.00914.x     Document Type: Article

References (25)

1. Kramer H, Molitch ME. Screening for kidney disease in adults with diabetes. Diabetes Care 2005; 28: 1813-1816.
2. Gross JL, de Azevedo MJ, Silveiro SP, Canani LH, Caramori ML, Zelmanovitz T. Diabetic nephropathy: Diagnosis, prevention, and treatment. Diabetes Care 2005; 28: 164-176.
3. Herman GA, Stein PP, Thornberry NA, Wagner JA. Dipeptidyl peptidase-4 inhibitors for the treatment of type 2 diabetes: Focus on sitagliptin. Clin Pharmacol Ther 2007; 81: 761-767.
4. Drucker DJ, Nauck MA. GLP-1R agonists (incretin mimetics) and DPP-4 inhibitors (incretin enhancers) for the treatment of type 2 diabetes. Lancet 2006; 368: 1696-1705.
5. Drucker DJ. The biology of incretin hormones. Cell Metab 2006; 3: 153-165.
6. Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia 2006; 49: 2564-2571.
7. Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care 2006; 29: 2632-2637.
8. Herman GA, Bergman A, Stevens C et al. Effect of single oral doses of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on incretin and plasma glucose levels following an oral glucose tolerance test in patients with type 2 diabetes. J Clin Endocrinol Metab 2006; 91: 4612-4619.
9. Charbonnel B, Karasik A, Liu J, Wu M, Meininger G. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled on metformin alone. Diabetes Care 2006; 29: 2638-2643.
10. Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein PP. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: A 24-week, multicenter, randomized, double-blind, placebo-controlled parallel group study. Clin Ther 2006; 28: 1556-1568.
11. Herman GA, Stevens C, Van Dyck K et al. Pharmacokinetics and pharmacodynamics of single doses of sitagliptin, an inhibitor of dipeptidyl peptidase-IV, in healthy subjects. Clin Pharm Therap 2005; 78: 675-688.
12. Chu XY, Bleasby K, Yabut J et al. Transport of the dipeptidyl peptidase-4 inhibitor sitagliptin by human organic anion transporter 3, organic anion transporting polypeptide 4C1, and multidrug resistance P-glycoprotein. J Pharmacol Exp Ther 2007; 321: 673-683.
13. Bergman AJ, Cote J, Yi B et al. Effect of renal insufficiency on the pharmacokinetics of sitagliptin, a dipeptidyl peptidase-4 inhibitor. Diabetes Care 2007; 30: 1862-1864.
14. Product Information. JANUVIA (sitagliptin). Whitehouse Station, NJ: Merck & Co, Inc, 2007.
15. KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis 2007; 49: S12-S154.
16. Cockroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
17. Yale JF. Oral antihyperglycemic agents and renal disease: New agents, new concepts. J Am Soc Nephrol 2005; 16 (Suppl. 1): S7-S10.
18. Lubowsky ND, Siegel R, Pittas AG. Management of glycemia in patients with diabetes mellitus and CKD. Am J Kidney Dis 2007; 50: 865-879.
19. Rave K, Heise T, Pfutzner A, Heinemann L, Sawicki PT. Impact of diabetic nephropathy on pharmacodynamic and pharmacokinetic properties of insulin in type 1 diabetic patients. Diabetes Care 2001; 24: 886-890.
20. Stumvoll M. Glucose production by the human kidney - its importance has been underestimated. Nephrol Dial Transplant 1998; 13: 2996-2999.
21. Karasik A, Aschner P, Katzeff H, Davies MJ, Stein PP. Sitagliptin, a DPP-4 inhibitor for the treatment of patients with type 2 diabetes: A review of recent clinical trials. Curr Med Res Opin 2008; 24: 489-496.
22. Mest HJ, Mentlein R. Dipeptidyl peptidase inhibitors as new drugs for the treatment of type 2 diabetes. Diabetologia 2005; 48: 616-620.
23. Foley RN, Murray AM, Li S et al. Chronic kidney disease and the risk for cardiovascular disease, renal replacement, and death in the United States Medicare population, 1998 to 1999. J Am Soc Nephrol 2005; 16: 489-495.
24. United States Renal Data System. 2005. Annual Data Report. Available from URL: http://www.usrds.org/adr_2005
25. Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: A randomized, double-blind, non-inferiority trial. Diabetes Obes Metab 2007; 9: 194-205.