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Adverse Events Rule Out Taspoglutide in Diabetes Patients

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