Linagliptin treatment in subjects with type 2 diabetes with and without mild-to-moderate renal impairment

Diabetes, Obesity and Metabolism

Volumn 16, Issue 6, 2014, Pages 560-568

  Groop, Per Henrik ^a,b,c   Del Prato, S ^d   Taskinen, M R ^a   Owens, D R ^e   Gong, Y ^f   Crowe, S ^f   Patel, S ^g   von Eynatten, M ^f   Woerle, H J ^f  

^a HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^b FOLKHÄLSAN INSTITUTE OF GENETICS   (Finland)

^c BAKER IDI HEART AND DIABETES INSTITUTE   (Australia)

^d UNIVERSITY OF PISA   (Italy)

^e SWANSEA UNIVERSITY   (United Kingdom)

^f BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^g BOEHRINGER INGELHEIM LTD   (United Kingdom)

Author keywords

Diabetic nephropathy; DPP 4 inhibitor; Glycaemic control; Incretin therapy; Type 2 diabetes

Indexed keywords

ACETYLSALICYLIC ACID; ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM ANTAGONIST; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIPEPTIDYL PEPTIDASE IV INHIBITOR; DIURETIC AGENT; FIBRIC ACID DERIVATIVE; HEMOGLOBIN A1C; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LINAGLIPTIN; METFORMIN; NICOTINIC ACID; PLACEBO; SULFONYLUREA; ANTIDIABETIC AGENT; PURINE DERIVATIVE; QUINAZOLINE DERIVATIVE;

ADD ON THERAPY; ADULT; ARTICLE; CLINICAL EVALUATION; COMORBIDITY; CONTROLLED STUDY; COUGHING; DISEASE DURATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; KIDNEY FUNCTION; MALE; MILD RENAL IMPAIRMENT; MODERATE RENAL IMPAIRMENT; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; UPPER RESPIRATORY TRACT INFECTION; AGED; CHEMICALLY INDUCED; DIABETES MELLITUS, TYPE 2; DIABETIC NEPHROPATHIES; META ANALYSIS; MIDDLE AGED; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); SEVERITY OF ILLNESS INDEX;

ADULT; AGED; CLINICAL TRIALS, PHASE III AS TOPIC; DIABETES MELLITUS, TYPE 2; DIABETIC NEPHROPATHIES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; PLACEBOS; PURINES; QUINAZOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEVERITY OF ILLNESS INDEX;

EID: 84899640186     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12281     Document Type: Article

References (46)

1. National Kidney Foundation. KDOQI clinical practice guideline for diabetes and CKD: 2012 update. Am J Kidney Dis 2012; 60: 850-886.
2. Koro CE, Lee BH, Bowlin SJ. Antidiabetic medication use and prevalence of chronic kidney disease among patients with type 2 diabetes mellitus in the United States. Clin Ther 2009; 31: 2608-2617.
3. Retnakaran R, Cull CA, Thorne KI, Adler AI, Holman RR, UKPDS Study Group. Risk factors for renal dysfunction in type 2 diabetes: U.K. Prospective Diabetes Study 74. Diabetes 2006; 55: 1832-1839.
4. Meyers JL, Candrilli SD, Kovacs B. Type 2 diabetes mellitus and renal impairment in a large outpatient electronic medical records database: rates of diagnosis and antihyperglycemic medication dose adjustment. Postgrad Med 2011; 123: 133-143.
5. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Diseases: U.S. Renal Data System, USRDS 2011 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Bethesda: MD: National Institutes of Health, 2011.
6. Plantinga LC, Crews DC, Coresh J et al. Prevalence of chronic kidney disease in US adults with undiagnosed diabetes or prediabetes. Clin J Am Soc Nephrol 2010; 5: 673-682.
7. American Diabetes Association. Standards of medical care in diabetes-2013. Diabetes Care 2013; 36(Suppl. 1): S11-S66.
8. Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med 2003; 348: 383-393.
9. Advance Collaborative Group, Patel A, MacMahon S et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008; 358: 2560-2572.
10. Ismail-Beigi F, Craven T, Banerji MA et al. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet 2010; 376: 419-430.
11. Bakris GL. Recognition, pathogenesis, and treatment of different stages of nephropathy in patients with type 2 diabetes mellitus. Mayo Clin Proc 2011; 86: 444-456.
12. Inzucchi SE, Bergenstal RM, Buse JB et al. 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.
13. Deacon CF. Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diabetes Obes Metab 2011; 13: 7-18.
14. Scheen AJ. A review of gliptins in 2011. Expert Opin Pharmacother 2012; 13: 81-99.
15. Bristol-Myers Squibb. Onglyza [package insert]. Princeton, NJ: Bristol-Myers Squibb, 2013. Available from URL: http://packageinserts.bms.com/pi/pi_onglyza.pdf. Accessed 10 November 2013.
16. Merck & Co Inc. Januvia [package insert]. Whitehouse Station, NJ: Merck & Co., Inc, 2013. Available from URL: http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf. Accessed 10 November 2013.
17. Novartis Pharmaceuticals UK Ltd. Galvus [summary of product characteristics]. Horsham, West Sussex: Novartis Pharmaceuticals UK, Ltd, 2013. Available from URL: http://www.medicines.org.uk/EMC/medicine/20734/SPC/Galvus%2050%20mg%20Tablets/. Accessed 10 November 2013.
18. Boehringer Ingelheim Pharmaceuticals Inc. Tradjenta [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc, 2013 Available from URL: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf. Accessed 9 November 2013.
19. Graefe-Mody U, Friedrich C, Port A et al. Effect of renal impairment on the pharmacokinetics of the dipeptidyl peptidase-4 inhibitor linagliptin(*). Diabetes Obes Metab 2011; 13: 939-946.
20. Friedrich C, Emser A, Woerle HJ, Graefe-Mody U. Renal impairment has no clinically relevant effect on the long-term exposure of linagliptin in patients with type 2 diabetes. Am J Ther 2013; 20: 618-621.
21. McGill JB, Sloan L, Newman J et al. Long-term efficacy and safety of linagliptin in patients with type 2 diabetes and severe renal impairment: a 1-year, randomized, double-blind, placebo-controlled study. Diabetes Care 2013; 36: 237-244.
22. Del Prato S, Barnett AH, Huisman H, Neubacher D, Woerle HJ, Dugi KA. Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. Diabetes Obes Metab 2011; 13: 258-267.
23. Owens DR, Swallow R, Dugi KA, Woerle HJ. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabet Med 2011; 28: 1352-1361.
24. Taskinen MR, Rosenstock J, Tamminen I et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab 2011; 13: 65-74.
25. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999; 130: 461-470.
26. Rigalleau V, Lasseur C, Perlemoine C et al. Estimation of glomerular filtration rate in diabetic subjects: Cockcroft formula or modification of diet in renal disease study equation? Diabetes Care 2005; 28: 838-843.
27. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
28. 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: Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 1998. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072127.pdf. Accessed 10 November 2013.
29. Workgroup on Hypoglycemia American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005; 28: 1245-1249.
30. Fravel MA, McDanel DL, Ross MB, Moores KG, Starry MJ. Special considerations for treatment of type 2 diabetes mellitus in the elderly. Am J Health Syst Pharm 2011; 68: 500-509.
31. Barnett AH, Huisman H, Jones R, von Eynatten M, Patel S, Woerle HJ. Linagliptin for patients aged 70years or older with type 2 diabetes inadequately controlled with common antidiabetes treatments: a randomised, double-blind, placebo-controlled trial. Lancet 2013; 382: 1413-1423.
32. Schernthaner G, Barnett AH, Emser A et al. Safety and tolerability of linagliptin: a pooled analysis of data from randomized controlled trials in 3572 patients with type 2 diabetes mellitus. Diabetes Obes Metab 2012; 14: 470-478.
33. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for diabetes and chronic kidney disease. Am J Kidney Dis 2007; 49: S12-S154.
34. Nauck MA, Vilsbøll T, Gallwitz B, Garber A, Madsbad S. Incretin-based therapies: viewpoints on the way to consensus. Diabetes Care 2009; 32(Suppl. 2): S223-S231.
35. Hermansen K, Kipnes M, Luo E et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab 2007; 9: 733-745.
36. Adler AI, Stevens RJ, Manley SE, Bilous RW, Cull CA, Holman RR. Development and progression of nephropathy in type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS 64). Kidney Int 2003; 63: 225-232.
37. Heerspink HJ, Holtkamp FA, de Zeeuw D, Ravid M. Monitoring kidney function and albuminuria in patients with diabetes. Diabetes Care 2011; 34(Suppl. 2): S325-S329.
38. Groop PH, Cooper ME, Perkovic V, Emser A, Woerle HJ, von Eynatten M. Linagliptin lowers albuminuria on top of recommended standard treatment in patients with type 2 diabetes and renal dysfunction. Diabetes Care 2013; 36: 3460-3468.
39. Lipska KJ, Bailey CJ, Inzucchi SE. Use of metformin in the setting of mild-to-moderate renal insufficiency. Diabetes Care 2011; 34: 1431-1437.
40. Philbrick AM, Ernst ME, McDanel DL, Ross MB, Moores KG. Metformin use in renal dysfunction: is a serum creatinine threshold appropriate? Am J Health Syst Pharm 2009; 66: 2017-2023.
41. Abe M, Okada K, Soma M. Antidiabetic agents in patients with chronic kidney disease and end-stage renal disease on dialysis: metabolism and clinical practice. Curr Drug Metab 2011; 12: 57-69.
42. Chan JC, Scott R, Arjona Ferreira JC et al. Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes Metab 2008; 10: 545-555.
43. Lukashevich V, Schweizer A, Shao Q, Groop PH, Kothny W. Safety and efficacy of vildagliptin versus placebo in patients with type 2 diabetes and moderate or severe renal impairment: a prospective 24-week randomized placebo-controlled trial. Diabetes Obes Metab 2011; 13: 947-954.
44. Nowicki M, Rychlik I, Haller H et al. 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. Int J Clin Pract 2011; 65: 1230-1239.
45. Nowicki M, Rychlik I, Haller H, Warren ML, Suchower L, Gause-Nilsson I. 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.
46. McGill J, Yki-Järvinen H, Emser A, von Eynatten M, Woerle HJ. Safety and efficacy of linagliptin in combination with insulin in patients with type 2 diabetes (T2D) and declining renal function. J Am Soc Nephrol 2012; 23: 219A.