Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

Summary

The purpose of this study is to determine if albiglutide is safe and effective in the treatment of 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 Plus Metformin vs Albiglutide 30 mg Plus Metformin; p <0.0001; t-test, 2 sided; note: The p-value is for superiority testing of albiglutide over placebo at 0.05 level. NCT00838903 ↗

registry analysis (superiority or other test); Sitagliptin 100 mg Plus Metformin vs Albiglutide 30 mg Plus Metformin; p = 0.0001; t-test, 2 sided; note: The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level. NCT00838903 ↗

registry analysis (superiority or other test); Glimepiride 2 mg Plus Metformin vs Albiglutide 30 mg Plus Metformin; p = 0.0033; t-test, 2 sided; note: The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level. NCT00838903 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glimepiride	Small molecule	—	—
Comparator	Sitagliptin	Small molecule	—	—
Subject	albiglutide	Peptide	—	—
Background	Metformin	Small molecule	—	—

Indications