Efficacy and safety of the once-weekly GLP-1 receptor agonist albiglutide versus sitagliptin in patients with type 2 diabetes and renal impairment: A randomized phase III study

Diabetes Care

Volumn 37, Issue 10, 2014, Pages 2723-2730

  Leiter, Lawrence A ^a   Carr, Molly C ^b   Stewart, Murray ^b   Jones Leone, Angela ^b   Scott, Rhona ^c   Yang, Fred ^b   Handelsman, Yehuda ^d  

^a ST MICHAEL'S HOSPITAL   (Canada)

^b GLAXOSMITHKLINE   (United States)

^c GLAXOSMITHKLINE   (United Kingdom)

^d Metabolic Institute of America   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALBIGLUTIDE; GLUCOSE; HEMOGLOBIN A1C; SITAGLIPTIN; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE 1; GLUCAGON RECEPTOR; GLUCAGON-LIKE PEPTIDE-1 RECEPTOR; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; PYRAZINE DERIVATIVE; RGLP-1 PROTEIN; TRIAZOLE DERIVATIVE;

ADULT; ANAPHYLAXIS; ANEMIA; ANGIONEUROTIC EDEMA; ARTICLE; CLINICAL ASSESSMENT; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISEASE DURATION; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FACE EDEMA; FEMALE; GLOMERULUS FILTRATION RATE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; HYPOGLYCEMIA; LIP SWELLING; MAJOR CLINICAL STUDY; MALE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREATITIS; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SWELLING; THYROID CANCER; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; WEIGHT GAIN; WEIGHT REDUCTION; AGED; AGONISTS; ANALOGS AND DERIVATIVES; BLOOD; CLINICAL TRIAL; COMPLICATION; DIABETES MELLITUS, TYPE 2; DIABETIC NEPHROPATHIES; DRUG ADMINISTRATION; DRUG EFFECTS; MIDDLE AGED; MULTICENTER STUDY; RENAL INSUFFICIENCY; TREATMENT OUTCOME;

AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DIABETIC NEPHROPATHIES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; PYRAZINES; RECEPTORS, GLUCAGON; RENAL INSUFFICIENCY; TREATMENT OUTCOME; TRIAZOLES;

EID: 84908179637     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc13-2855     Document Type: Article

References (29)

1. 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.
2. Dreyer G, Hull S, Aitken Z, Chesser A, Yaqoob MM. The effect of ethnicity on the prevalence of diabetes and associated chronic kidney disease. QJM 2009;102:261-269.
3. Middleton RJ, Foley RN, Hegarty J, et al. The unrecognized prevalence of chronic kidney disease in diabetes. Nephrol Dial Transplant 2006; 21:88-92.
4. New JP, Middleton RJ, Klebe B, et al. Assessing the prevalence, monitoring and management of chronic kidney disease in patients with diabetes compared with those without diabetes in general practice. Diabet Med 2007;24:364-369.
5. Garber AJ, Abrahamson MJ, Barzilay JI, et al. American Association of Clinical Endocrinologists' comprehensive diabetes management algorithm 2013 consensus statement dexecutive summary. Endocr Pract 2013;19:536-557.
6. Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA 2010;303:1410-1418.
7. Pioglitazone package insert [Internet], 2011. Deerfield, IL, Takeda Pharmaceuticals America, Inc. Available from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=search.drugdetails. Accessed 15 August 2013.
8. Kahn SE, Haffner SM, HeiseMA, et al.; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355:2427-2443.
9. Byetta US package insert [Internet], 2011. San Diego, CA, Amylin Pharmaceuticals. Available from http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/021773s029s030lbl.pdf. Accessed 21 October 2013.
10. Victoza US package insert [Internet], 2012. Princeton, NJ, Novo Nordisk. Available from http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/022341s007s009s013lbl.pdf. Accessed 21 October 2013.
11. Januvia US package insert [Internet], 2012. Whitehouse Station, NJ, Merck & Co. Available from http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/021995s023lbl.pdf. Accessed 21 October 2013.
12. Ampudia-Blasco FJ, Rossetti P, Ascaso JF. Basal plus basal-bolus approach in type 2 diabetes. Diabetes Technol Ther 2011;13(Suppl. 1): S75-S83.
13. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 2013;36:1384-1395.
14. Gross JL, Kramer CK, Leitão CB, et al.; Diabetes and Endocrinology Meta-analysis Group (DEMA). Effect of antihyperglycemic agents added to metformin and a sulfonylurea on glycemic control and weight gain in type 2 diabetes: a network meta-analysis. Ann Intern Med 2011;154:672-679.
15. Carver C. Insulin treatment and the problem of weight gain in type 2 diabetes. Diabetes Educ 2006;32:910-917.
16. Bush MA, Matthews JE, De Boever EH, et al. Safety, tolerability, pharmacodynamics and pharmacokinetics of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in healthy subjects. Diabetes Obes Metab 2009;11:498- 505.
17. Madsbad S, Kielgast U, Asmar M, Deacon CF, Torekov SS, Holst JJ. An overview of onceweekly glucagon-like peptide-1 receptor agonists- Available efficacy and safety data and perspectives for the future. Diabetes Obes Metab 2011;13:394-407.
18. Rosenstock J, Stewart MW. Albiglutide. Glucagon-like peptide GLP-1 receptor agonist, treatment of type 2 diabetes. Drugs Future 2010;35:701-712.
19. Rosenstock J, Reusch J, Bush M, Yang F, Stewart M; Albiglutide Study Group. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care 2009;32:1880-1886.
20. Tomkin GH. Albiglutide, an albumin-based fusion of glucagon-like peptide 1 for the potential treatment of type 2 diabetes. Curr Opin Mol Ther 2009;11:579-588.
21. Seino Y, Nakajima H, Miyahara H, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP- 1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin 2009;25:3049-3057.
22. National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis 2002;39(Suppl. 1):S1-S266.
23. Young MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmocokinetics, efficacy, and safety of albiglutide. Post grad Med 2014;126:35-36.
24. 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.
25. Ahr én B, Stewart M, Cirkel D, et al. Weekly GLP-1 receptor agonist albiglutide is superior to sitagliptin or glimepiride in patients with type 2 diabetes mellitus on metformin at the 104 week primary endpoint. Diabetes Care 2014;37: 2141-2148.
26. Pratley R, Stewart M, Cirkel D, Ye J, Perry C, Carr MC. Harmony 4: 52-week efficacy of albiglutide vs insulin glargine in patients with type 2 diabetes mellitus. Diabetologia 2013;56(Suppl. 1):S360-S361.
27. Nauck M, Stewart M, Perkins C, et al. Harmony 2 results at week 52 primary endpoint: once-weekly albiglutide monotherapy for patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetologia 2013;56(Suppl. 1):S360.
28. Reusch J, Stewart M, Perkins C, et al. Harmony 1 results at week 52 primary endpoint: once-weekly albiglutide vs placebo in patients with type 2 diabetes mellitus not controlled on pioglitazone 6 metformin. Diabetologia 2013; 56(Suppl. 1):S359-S360.
29. Stewart M, Yang F, Perry C, Carr MC, Home PD. 52-week efficacy of albiglutide vs placebo vs pioglitazone in triple therapy (background metformin and glimepiride) in patients with type 2 diabetes: Harmony 5 study. Diabetologia 2013; 56(Suppl. 1):S361.