drugset / Trial / NCT00839527
A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes
Timeline
- Start
- 2009-02
- Primary completion
- 2012-01
- Completion
- 2013-04
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo + Metformin + Glimepiride vs Albiglutide + Metformin + Glimepiride; p <0.0001; Mean Difference (Net) -0.87 NCT00839527 ↗
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.
- 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 |
|---|---|---|---|---|
| Comparator | Pioglitazone | Small molecule | — | — |
| Subject | albiglutide | Peptide | — | Subcutaneous |
| Background | Glimepiride | Small molecule | — | — |
| Background | Metformin | Small molecule | — | — |