Successful studies can help to determine how new products can help in improving lives. But, studies that are not successful can provide information also….
In overweight diabetics, once-weekly taspoglutide provided better glycemic control than twice-daily exenatide, but with "unacceptable" side effects including nausea and vomiting. As a result, Roche dropped development of the long-acting glucagon-like peptide 1 receptor agonist in February 2011.
In a November 8th online paper in Diabetes Care, Dr. Julio Rosenstock of Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas and colleagues report on an open-label trial of the drug involving 1,189 overweight patients with inadequately controlled type 2 diabetes on metformin, with or without a thiazolidinedione. They were randomly assigned to receive subcutaneous taspoglutide 10 or 20 mg weekly or exenatide 10 mcg twice daily. Their mean baseline hemoglobin A1C level was 8.1%.
At 24 weeks, A1C fell by 1.24% in the 10 mg group and 1.31% in the 20 mg group. Both reductions were significantly greater than the 0.98% drop seen with exenatide.
Both taspoglutide doses also reduced fasting plasma glucose significantly more than did exenatide.
Weight loss was comparable with a drop of 1.6 kg in the 10 mg group, 2.3 kg in the 20 mg group, and 2.3 kg with exenatide.
However, the study drop-out rate was almost twice as high in the taspoglutide group (34%) as in the exenatide group (16%). The main problems were gastrointestinal, but allergic and injection-site reactions were also more common with taspoglutide, and 49% of patients showed antibodies against the drug.
Despite the disappointing results, the researchers conclude that the findings overall could help provide perspective for other long-acting glucagon-like peptide 1 receptor agonists in use and under development.
Published online before print November 8, 2012, doi: 10.2337/dc12-0709 Diabetes Care November 8, 2012