Albiglutide, a Once-Weekly GLP-1RA, for the Treatment of Type 2 Diabetes
Main Article Content
Abstract
Abstract
Choosing an agent for initial or add-on therapy in type 2 diabetes can be overwhelming for clinicians due to the numerous agents available. Patient specific characteristics, such as the presence of obesity or renal complications, further complicate treatment choices. In clinical studies, albiglutide has been compared to placebo, oral diabetes medications, as well as other injectable agents. The most common adverse effects associated with albiglutide are gastrointestinal in nature, an adverse effect which often subsides with continued use. Serious adverse effects, as with all GLP-1RAs, warrant cautious use of albiglutide in certain patient populations. In addition to its proven safety and efficacy profile, albiglutide may afford patients the added benefits of potential weight loss and improved adherence.
Keywords:
albiglutide, diabetes, GLP-1RA, treatment
Article Details
How to Cite
ST. ONGE, Erin; MILLER, Shannon; CLEMENTS, Elizabeth.
Albiglutide, a Once-Weekly GLP-1RA, for the Treatment of Type 2 Diabetes.
Medical Research Archives, [S.l.], v. 5, n. 11, nov. 2017.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/1603>. Date accessed: 21 nov. 2024.
doi: https://doi.org/10.18103/mra.v5i11.1603.
Section
Review Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
References
1) American Diabetes Association. Statistics about diabetes. 19 July 2017. Available at http://www.diabetes.org/diabetes-basics/statistics/. Accessed August 12, 2017.
2) World Health Organization. 10 Facts on Diabetes. April 2016. Available at http://www.who.int/features/factfiles/diabetes/en/. Accessed August 15, 2017.
3) American Diabetes Association. Standards of medical care in diabetes – 2017. Diabetes Care. 2017; 40: S1-142.
4) Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2016 executive summary. Endocrine Practice. 2016;22(1);84-113.
5) Tibaldi JM. Incorporating incretin-based therapies into clinical practice for patients with type 2 diabetes. Advances in Therapy. 2014;31:289-317
6) Tanzeum [package insert]. Research Triangle Park, NC: GlaxoSmithKline LLC; 2016.
7) Trietley G, Skef S. Albiglutide (Tanzeum) for diabetes mellitus. Am Fam Physician 2017; 95(8): 521-522.
8) Reusch J, Stewart MW, Perkins CM, et al. Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not controlled on pioglitazone, with or without metformin. Diabetes Obes Metab 2014 Dec;16(12):1257-64
9) Nauck MA, Stewart MW, Perkins C, et al Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetologia. 2016 Feb;59(2):266-74.
10) Ahren B, Johnson SL, Stewart M, et al. HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin. Diabetes Care 2014 Aug; 37(8):2141-8.
11) Weissman PN, Carr MC, Cirkel DT, et al. HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea. Diabetologia. 2014 Dec;57(12):2475-84
12) Home PD, Shamanna P, Stewart M, et al. Efficacy and tolerability of albiglutide versus placebo or pioglitazone over 1 year in people with type 2 diabetes currently taking metformin and glimepiride: HARMONY 5. Diabetes Obes Metab 2015 Feb; 17(2):179-87.
13) Rosenstock J, Fonseca VA, Gross JL, et al. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care 2014 Aug; 37(8): 2317-25.
14) Leiter L, Gross J, Chow F, et al. Once weekly glucagon-like peptide-1 receptor agonist albiglutide vs. prandial insulin added to basal insulin in patients with type 2 diabetes mellitus: Results over 52 weeks. J Diabetes Complications Aug; 2017 Aug; 31(8):1283-85.
15) Pratley RE, Nauck MA, Barnett AH, et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diab Endocrinol 2014 (2); 2289-97
16) Leiter, L, Carr M, Stewart M, et al. 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 2014; 37(10): 2723-30.
17) FDA. Guidance for Industry. December 2008. Available at https://www.fda.gov/downloads/Drugs/.../Guidances/ucm071627.pdf. Accessed July 28, 2017.
18) Lepore JJ. JACC: Heart Failure 2016; 4(7): 559-566.
19) Darpo B, Zhou M, Matthews J, et al. Albiglutide does not prolong QTc interval in healthy subjects: a thorough ECG study. Diabetes Ther 2014; 5: 141-153.
20) Lorenz M, Lawson F, Owens D, et al. Differential effects of glucagon-like peptide-1 receptor agonists on heart rate. Cardiovascular Diabetol 2017; 16(6): 1-10.
21) FDA. FDA Requires REMS Safety Information. Available at http://www.tanzeumrems.com/assets/pdf/REMS_Factsheet.pdf. Accessed August 3, 2017.
22) Jain N, Savani M, Agarwal M, Sands C. Albiglutide-induced pancreatitis. Ther Adv Drug Saf 2016; 7(6): 236-238.
23) Monami M, Nreu B, Scatena A, et al. Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): data from randomized controlled trials. Diabetes Obes Metab 2017: 1-9.
24) Guo X, Yang Q, Dong J, et al. Tumor risk with once-weekly glucagon-like peptide-1 receptor agonists in type 2 diabetes mellitus patients: a systematic review. Clin Drug Investig 2016; 36: 433-441.
25) Guo X. the value of short- and long-acting glucagon-like peptide-1 agonists in the management of type 2 diabetes mellitus: experience with exenatide. Curr Med Res Opin 2016; 32(1): 61-76.
26) Htike Z, Zaccardi F, Papamargaritis D, et al. Efficacy and safety of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a systematic review and mixed-treatment comparison analysis. Diabetes Obes Metab 2017; 19: 524-536.
27) Triplitt C, Solis-Herrera C. GLP-1 receptor agonists: practical considerations for clinical practice. Diabetes Educator 2015; 41(Supp 1): 32S-46S.
28) Bettge K, Kahle M, Abd El Aziz M, Meier J, Nauck M. Occurrence of nausea, vomiting and diarrhea reported as adverse events in clinical trials studying glucagon-like peptide-1 receptor agonists: a systematic analysis of published clinical trials. Diabetes Obes Metab 2017; 19(3): 336-347.
29) Trujillo J, Nuffer W, Ellis S. GLP-1 receptor agonists: a review of head-to-head clinical studies. Ther Adv Endocrinol Metab 2015; 6(1): 19-28.
1) American Diabetes Association. Statistics about diabetes. 19 July 2017. Available at http://www.diabetes.org/diabetes-basics/statistics/. Accessed August 12, 2017.
2) World Health Organization. 10 Facts on Diabetes. April 2016. Available at http://www.who.int/features/factfiles/diabetes/en/. Accessed August 15, 2017.
3) American Diabetes Association. Standards of medical care in diabetes – 2017. Diabetes Care. 2017; 40: S1-142.
4) Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2016 executive summary. Endocrine Practice. 2016;22(1);84-113.
5) Tibaldi JM. Incorporating incretin-based therapies into clinical practice for patients with type 2 diabetes. Advances in Therapy. 2014;31:289-317
6) Tanzeum [package insert]. Research Triangle Park, NC: GlaxoSmithKline LLC; 2016.
7) Trietley G, Skef S. Albiglutide (Tanzeum) for diabetes mellitus. Am Fam Physician 2017; 95(8): 521-522.
8) Reusch J, Stewart MW, Perkins CM, et al. Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not controlled on pioglitazone, with or without metformin. Diabetes Obes Metab 2014 Dec;16(12):1257-64
9) Nauck MA, Stewart MW, Perkins C, et al Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetologia. 2016 Feb;59(2):266-74.
10) Ahren B, Johnson SL, Stewart M, et al. HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin. Diabetes Care 2014 Aug; 37(8):2141-8.
11) Weissman PN, Carr MC, Cirkel DT, et al. HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea. Diabetologia. 2014 Dec;57(12):2475-84
12) Home PD, Shamanna P, Stewart M, et al. Efficacy and tolerability of albiglutide versus placebo or pioglitazone over 1 year in people with type 2 diabetes currently taking metformin and glimepiride: HARMONY 5. Diabetes Obes Metab 2015 Feb; 17(2):179-87.
13) Rosenstock J, Fonseca VA, Gross JL, et al. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care 2014 Aug; 37(8): 2317-25.
14) Leiter L, Gross J, Chow F, et al. Once weekly glucagon-like peptide-1 receptor agonist albiglutide vs. prandial insulin added to basal insulin in patients with type 2 diabetes mellitus: Results over 52 weeks. J Diabetes Complications Aug; 2017 Aug; 31(8):1283-85.
15) Pratley RE, Nauck MA, Barnett AH, et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diab Endocrinol 2014 (2); 2289-97
16) Leiter, L, Carr M, Stewart M, et al. 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 2014; 37(10): 2723-30.
17) FDA. Guidance for Industry. December 2008. Available at https://www.fda.gov/downloads/Drugs/.../Guidances/ucm071627.pdf. Accessed July 28, 2017.
18) Lepore JJ. JACC: Heart Failure 2016; 4(7): 559-566.
19) Darpo B, Zhou M, Matthews J, et al. Albiglutide does not prolong QTc interval in healthy subjects: a thorough ECG study. Diabetes Ther 2014; 5: 141-153.
20) Lorenz M, Lawson F, Owens D, et al. Differential effects of glucagon-like peptide-1 receptor agonists on heart rate. Cardiovascular Diabetol 2017; 16(6): 1-10.
21) FDA. FDA Requires REMS Safety Information. Available at http://www.tanzeumrems.com/assets/pdf/REMS_Factsheet.pdf. Accessed August 3, 2017.
22) Jain N, Savani M, Agarwal M, Sands C. Albiglutide-induced pancreatitis. Ther Adv Drug Saf 2016; 7(6): 236-238.
23) Monami M, Nreu B, Scatena A, et al. Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): data from randomized controlled trials. Diabetes Obes Metab 2017: 1-9.
24) Guo X, Yang Q, Dong J, et al. Tumor risk with once-weekly glucagon-like peptide-1 receptor agonists in type 2 diabetes mellitus patients: a systematic review. Clin Drug Investig 2016; 36: 433-441.
25) Guo X. the value of short- and long-acting glucagon-like peptide-1 agonists in the management of type 2 diabetes mellitus: experience with exenatide. Curr Med Res Opin 2016; 32(1): 61-76.
26) Htike Z, Zaccardi F, Papamargaritis D, et al. Efficacy and safety of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a systematic review and mixed-treatment comparison analysis. Diabetes Obes Metab 2017; 19: 524-536.
27) Triplitt C, Solis-Herrera C. GLP-1 receptor agonists: practical considerations for clinical practice. Diabetes Educator 2015; 41(Supp 1): 32S-46S.
28) Bettge K, Kahle M, Abd El Aziz M, Meier J, Nauck M. Occurrence of nausea, vomiting and diarrhea reported as adverse events in clinical trials studying glucagon-like peptide-1 receptor agonists: a systematic analysis of published clinical trials. Diabetes Obes Metab 2017; 19(3): 336-347.
29) Trujillo J, Nuffer W, Ellis S. GLP-1 receptor agonists: a review of head-to-head clinical studies. Ther Adv Endocrinol Metab 2015; 6(1): 19-28.