Long-term treatment with the dipeptidyl peptidase-4 inhibitor saxagliptin in patients with type 2 diabetes mellitus and renal impairment: A randomised controlled 52-week efficacy and safety study

International Journal of Clinical Practice

Volumn 65, Issue 12, 2011, Pages 1230-1239

  Nowicki, M ^a   Rychlik, I ^b   Haller, H ^c   Warren, M ^d   Suchower, L ^e   Gause Nilsson, I ^f   Schutzer K M ^f  

^a MEDICAL UNIVERSITY OF LODZ   (Poland)

^b CHARLES UNIVERSITY   (Czech Republic)

^c HANNOVER MEDICAL SCHOOL   (Germany)

^d Physicians East PA   (United States)

^e ASTRAZENECA   (United Kingdom)

^f ASTRAZENECA R AND D   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

CREATININE; GLUCOSE; HEMOGLOBIN A1C; INSULIN; ORAL ANTIDIABETIC AGENT; PLACEBO; SAXAGLIPTIN;

ADULT; AGED; ANEMIA; ARTICLE; CONTROLLED STUDY; CREATININE CLEARANCE; DIET RESTRICTION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; GLUCOSE BLOOD LEVEL; HEMODIALYSIS; HUMAN; HYPERTENSION; HYPOGLYCEMIA; KIDNEY DISEASE; KIDNEY FAILURE; LONG TERM CARE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; URINARY TRACT INFECTION;

ADAMANTANE; AGED; ANALYSIS OF VARIANCE; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DIABETIC NEPHROPATHIES; DIPEPTIDES; DOUBLE-BLIND METHOD; FASTING; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; KIDNEY FAILURE, CHRONIC; TREATMENT OUTCOME;

EID: 81755181497     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2011.02812.x     Document Type: Article

References (38)

1. US Renal Data System. USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2010.
2. Soldatos G, Cooper ME,. Diabetic nephropathy: important pathophysiologic mechanisms. Diabetes Res Clin Pract 2008; 82: S75-9.
3. Thomaseth K, Pacini G, Morelli P, et al., Importance of glycemic control on the course of glomerular filtration rate in type 2 diabetes with hypertension and microalbuminuria under tight blood pressure control. Nutr Metab Cardiovasc Dis 2008; 18: 632-8.
4. Patel A, MacMahon S, Chalmers J, et al., Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008; 358: 2560-72. (Pubitemid 351831357)
5. Davis TM, Brown SG, Jacobs IG, et al., Determinants of severe hypoglycemia complicating type 2 diabetes: the Fremantle diabetes study. J Clin Endocrinol Metab 2010; 95: 2240-7.
6. Fischer KF, Lees JA, Newman JH,. Hypoglycemia in hospitalized patients. Causes and outcomes. N Engl J Med 1986; 315: 1245-50. (Pubitemid 17049682)
7. Krepinsky J, Ingram AJ, Clase CM,. Prolonged sulfonylurea-induced hypoglycemia in diabetic patients with end-stage renal disease. Am J Kidney Dis 2000; 35: 500-5.
8. Odegard PS, Setter SM, Neumiller JJ,. Considerations for the pharmacological treatment of diabetes in older adults. Diabetes Spectr 2007; 20: 239-46.
9. GLUCOPHAGE, GLUCOPHAGE XR (Metformin Hydrochloride, Extended-Release Metformin Hydrochloride). Princeton, NJ: Full prescribing information, Bristol-Myers Squibb, 2009.
10. Tahrani AA, Piya MK, Barnett AH,. Saxagliptin: a new DPP-4 inhibitor for the treatment of type 2 diabetes mellitus. Adv Ther 2009; 26: 249-62.
11. Kirby M, Yu DMT, O'Connor SP, Gorrell MD,. Inhibitor selectivity in the clinical application of dipeptidyl peptidase-4 inhibition. Clin Sci 2010; 118: 31-41.
12. Onglyza (saxagliptin). Princeton, NJ/Wilmington, DE: Full Prescribing Information, Bristol-Myers Sqibb/AstraZeneca Pharmaceuticals LP, 2011.
13. Neumiller JJ, Campbell RK,. Saxagliptin: a dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus. Am J Health Syst Pharm 2010; 67: 1515-25.
14. Rosenstock J, Aguilar-Salinas C, Klein E, et al., Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes. Curr Med Res Opin 2009; 25: 2401-11.
15. Jadzinsky M, Pfutzner A, Paz-Pacheco E, et al., Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes Metab 2009; 11: 611-22.
16. DeFronzo R, Hissa MN, Garber AJ, et al., Once-daily saxagliptin added to metformin provides sustained glycemic control and is well tolerated over 102 weeks in patients with type 2 diabetes. Diabetes 2009; 58: 547-P.
17. DeFronzo RA, Hissa MN, Garber AJ, et al., The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care 2009; 32: 1649-55.
18. Göke B, Gallwitz B, Eriksson J, et al., Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial. Int J Clin Pract 2010; 64: 1619-31.
19. Scheen AJ, Charpentier G, Ostgren CJ, et al., Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus. Diabetes Metab Res Rev 2010; 26: 540-9.
20. Hollander P, Li J, Allen E, et al., Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab 2009; 94: 4810-9.
21. Chacra AR, Tan GH, Apanovitch A, et al., Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. Int J Clin Pract 2009; 63: 1395-406.
22. Nowicki M, Rychlik I, Haller H, et al., Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. Diabetes Obes Metab 2011; 13: 523-532.
23. Cockcroft DW, Gault MH,. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
24. Levey AS, Coresh J, Greene T, et al., Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med 2006; 145: 247-54. (Pubitemid 46768608)
25. U. K. Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837-53.
26. Pfützner A, Paz-Pacheco E, Allen E, et al., Initial combination therapy with saxagliptin and metformin provides sustained glycaemic control and is well tolerated for up to 76 weeks. Diabetes Obes Metab 2011; 13: 567-76.
27. Göke B, Gallwitz B, Eriksson J, et al., Saxagliptin vs glipizide as add-on therapy to metformin for type 2 diabetes mellitus (T2DM): long-term safety and efficacy [abstract]. Diabetes 2011; 60 (suppl 1): A305.
28. Sharif A, Baboolal K,. Diagnostic application of the A(1c) assay in renal disease. J Am Soc Nephrol 2010; 21: 383-5.
29. Mirani M, Berra C, Finazzi S, et al., Inter-day glycemic variability assessed by continuous glucose monitoring in insulin-treated type 2 diabetes patients on hemodialysis. Diabetes Technol Ther 2010; 12: 749-53.
30. McGill JB,. Liraglutide: effects beyond glycaemic control in diabetes treatment. Int J Clin Pract Suppl 2010; 64: 28-34.
31. Giorgino F, Leonardini A, Natalicchio A, Laviola L,. Multifactorial intervention in Type 2 diabetes: The promise of incretin-based therapies. J Endocrinol Invest 2011; 34: 69-77.
32. Jung HS, Kim HI, Kim MJ, et al., Analysis of hemodialysis-associated hypoglycemia in patients with type 2 diabetes using a continuous glucose monitoring system. Diabetes Technol Ther 2010; 12: 801-7.
33. European Medicines Agency. Note for Guidance on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Renal Function. London, UK: European Medicines Agency, 2004.
34. U.S. Department of Health and Human Services Food and Drug Administration. Guidance for Industry. Pharmacokinetics in Patients with Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing and Labeling. Rockville, MD: U.S. Food and Drug Administration, 1998.
35. Tatsuo H, Iwao O,. A repeated oral administration study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with impaired renal function in Japan: pharmacokinetic and pharmacodynamic study. J Clin Rheumatol 2011; 17: S27-34.
36. Gschwend S, Ebert W, Schultze-Mosgau M, Breuer J,. Pharmacokinetics and imaging properties of Gd-EOB-DTPA in patients with hepatic and renal impairment. Invest Radiol 2011; 49 (6): 556-566.
37. Boulton DW, Li L, Frevert EU, et al., Influence of renal or hepatic impairment on the pharmacokinetics of saxagliptin. Clin Pharmacokinet 2011; 50: 253-65.
38. Levey AS, de Jong PE, Coresh J, et al., The definition, classification, and prognosis of chronic kidney disease: a KDIGO Controversies Conference report. Kidney Int 2011; 80: 17-28.