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Clinical Trials

Date: 2011-11-16

Type of information:

phase: 3

Announcement: results of Harmony 7 study

Company: GSK (UK)

Product: albiglutide

Action mechanism: Albiglutide is an injectable form of human GLP-1 - a peptide that acts throughout the body to help maintain normal blood-sugar levels and to control appetite. It fuses human GLP-1 to human albumin. It is designed to have the potential to extended duration of action and allow for weekly or less-frequent injections.

Disease: type 2 diabetes

Therapeutic area: Metabolic diseases

Country:

Trial details: Harmony 7 is one of eight Phase III studies investigating the efficacy and safety of albiglutide in men and women with type 2 diabetes.
This 32 week, head-to-head, open-label, non-inferiority study, enrolled 841 patients, on single, dual or triple oral antidiabetes medicines, from eight countries. The patients were randomised to receive, via titration, either albiglutide 50 mg weekly or the maximum approved dose of liraglutide, 1.8 mg once daily. The primary endpoint was reduction in HbA1c, while secondary endpoints included other parameters of glucose control, weight, and safety and tolerability.

Latest news: GSK has announced that topline results have been received from the first of eight Phase III studies of albiglutide to complete in type 2 diabetes. Results showed a reduction in HbA1c of 0.78% for patients receiving albiglutide compared to a reduction of 0.99% for liraglutide. While albiglutide did demonstrate a statistically significant reduction in HbA1c from baseline (p<0.001), it did not meet the pre-specified primary endpoint of non-inferiority to liraglutide (95% CI: 0.08 – 0.34%).
The most common adverse events observed during this study were associated with gastrointestinal tolerability. Nausea and vomiting rates were lower in patients receiving albiglutide compared to those receiving liraglutide (9.9% versus 29.2% for nausea; 5% versus 9.3% for vomiting). While weight loss was observed for both treatments, the weight loss for patients receiving albiglutide (-0.62 kg) was lower than that observed with liraglutide (-2.21 kg).
Detailed analysis of the full data set from this study will be conducted in the coming months and the data will be submitted for presentation at a scientific meeting in 2012. In addition, initial results from the remaining seven Phase III studies will become available over the course of the next several months. An update on the clinical development programme will be the subject of a future announcement when a more complete view of the programme is available, expected in mid 2012. 
The Harmony Phase III programme comprises eight individual studies, known as Harmony 1 to Harmony 8.  The programme is investigating the efficacy, tolerability and safety, including cardiovascular safety, of albiglutide as mono- and add-on therapy, in patients with type 2 diabetes. The primary efficacy endpoint for all studies is the change from baseline in HbA1c compared to placebo and/or active comparators. A majority of the studies will include active comparators, including sulphonylurea, thiazolidinedione (TZD), insulin and a dipeptidyl peptidase four inhibitor (DPP IV).
The individual phase III studies are due to complete from late 2011 through early 2013. In addition to Harmony 7 one other study is expected to complete in late 2011. One study will complete in 2012. The remaining five studies are expected to complete by early 2013; these studies have a primary efficacy endpoint set at between 26 weeks and two years, which is expected to be achieved by mid 2012 for all studies. As per the study protocols, these studies will remain blinded past the primary efficacy endpoint until completion, which for most studies is three years.

Is general: Yes