Head-to-head study primary end point did not meet non-inferiority, but results support progression towards registration
GlaxoSmithKline (GSK) today announced that topline results have been received from the first of eight Phase III studies of albiglutide to complete in type 2 diabetes.
The study, known as Harmony 7, is a head-to-head study designed to compare albiglutide, an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist, to once-a-day liraglutide, an approved treatment for type 2 diabetes, in the same class. The primary endpoint of the study was reduction in HbA1c, a marker of the amount of glucose in the blood.
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).
“While the pre-specified margin of non-inferiority was not met, these topline data support continued progression towards registration of albiglutide as a possible future once weekly treatment for type 2 diabetes,” said Moncef Slaoui, Chairman of R&D at GSK. “This is the first of eight phase III studies to conclude and we continue to look forward to receiving the results of the remaining studies which will provide a more complete assessment of the profile of albiglutide in type 2 diabetes,” he added.
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.