A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

Summary

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

Timeline

Start

2010-05

Primary completion

2011-09

Completion

2011-09

Outcome

Missed primary endpoint

paper treatment difference was 0·21% (0·08-0·34; non-inferiority p value=0·0846). PMID 24703047 ↗

release “albiglutide demonstrated a statistically significant reduction in HbA1c from baseline (-0.78%; p<0.0001) but did not meet the pre-specified primary endpoint of non-inferiority to liraglutide” gsk.com ↗

Publications

• Pratley RE, Nauck MA, Barnett AH, Feinglos MN, Ovalle F, Harman-Boehm I, Ye J, Scott R, Johnson S, Stewart M, Rosenstock J; HARMONY 7 study group. 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 Diabetes Endocrinol. 2014 Apr;2(4):289-297. doi: 10.1016/S2213-8587(13)70214-6. Epub 2014 Feb 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Liraglutide	Peptide	1.8 mg	Subcutaneous
Subject	albiglutide	Peptide	50 mg	Subcutaneous

Indications