Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

Summary

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.

Timeline

Start

2009-01

Primary completion

2011-11

Completion

2013-02

Outcome

Met primary endpoint

registry Placebo vs Albiglutide 30 mg; p <0.0001; Mean Difference (Net) -0.84 (95% CI -1.11 to -0.58); ANCOVA NCT00849017 ↗

registry Placebo vs Albiglutide 50 mg; p <0.0001; Mean Difference (Net) -1.04 (95% CI -1.31 to -0.77); ANCOVA NCT00849017 ↗

Publications

• Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.
• Nauck MA, Stewart MW, Perkins C, Jones-Leone A, Yang F, Perry C, Reinhardt RR, Rendell M. 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. doi: 10.1007/s00125-015-3795-1. Epub 2015 Nov 17.
• Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
• Young MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med. 2014 May;126(3):35-46. doi: 10.3810/pgm.2014.05.2754.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	albiglutide	Peptide	30 mg	Subcutaneous
Subject	albiglutide	Peptide	50 mg	Subcutaneous

Indications