GSK presents new data for once-weekly Tanzeum/Eperzan (albiglutide) showing blood glucose lowering up to three years in type 2 diabetes

New data from secondary analyses of four randomised phase III studies being presented at the 74th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco show that patients enrolled in the studies who remained on Tanzeum/Eperzan (albiglutide), a once-weekly glucagon-like peptide (GLP-1) receptor agonist, continued to show blood glucose lowering at three years, consistent with results at the one year (52 week) primary endpoint.

In the four studies, the primary endpoint of blood glucose lowering, defined as the reduction of HbA1c (glycated haemoglobin, a measure of blood glucose levels) from baseline was assessed at 52 weeks (results previously announced). Those patients who remained in the study until year three continued to receive randomised treatment, as pre-specified in the study protocol, to further assess the efficacy and safety profile of albiglutide. Safety data for albiglutide in these studies were also consistent with the results observed up to year one. Commonly reported adverse reactions included nausea, diarrhoea, and injection site reactions.

Vlad Hogenhuis, Senior Vice-President and Head, Cardiovascular, Metabolic and Neurosciences Franchise, GSK, said: “While many phase III trials in type 2 diabetes are typically six months in duration, we set out to assess weekly-administered albiglutide for up to three years. We are proud to be able to present these data which further characterise the efficacy and safety profile of albiglutide.” 

The four phase III studies, entitled Harmony 1, 2, 4 and 5, evaluated albiglutide in monotherapy as well as in combination with OADs, against placebo, insulin glargine and a thiazolidinedione (pioglitazone). The studies enrolled patients at various stages of the disease, rangingfrom those with early stage disease to those whose type 2 diabetes had advanced to a point requiring insulin therapy.

GSK also released at the ADA additional analyses of data related to gastrointestinal adverse events from four pooled, placebo-controlled phase III studies, medication compliance data from three phase III studies and two subpopulation efficacy and safety analyses in Hispanic and African-American populations.