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Experts weigh safety, benefit of non-insulin diabetes therapies

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EASD Annual Meeting

Despite a wealth of recent data on glucagon-like peptide-1 agonists and incretin-based therapies, the safety concerns and additional benefits of non-insulin diabetes therapies have yet to be determined, Michael A. Nauck, MD, said during a presentation here.

“A number of important questions deserve answers in the near future,” Nauck, of the Diabetes Center at Bad Lauterberg im Harz, Germany, said in a press release. “For many of them, studies have already been initiated or are being planned.”

He highlighted several safety issues that have been reported with non-insulin diabetes therapies, such as pancreatitis and C-cell abnormalities, as well as possible benefits that have not yet been addressed.

Despite the known increased incidence of pancreatitis in obese patients with type 2 diabetes, there is no known mechanism to explain this, according to Nauck.

“Recent studies have suggested that sitagliptin (Januvia, Merck) and exenatide (Byetta, Amylin) are associated with changes at the cellular level in the exocrine pancreas of experimental animals. More information is needed before clinical consequences can be drawn,” he said.

Nauck also discussed the increased number and severity of high-dose GLP-1 agonists, which has raised concern about the associated increase in medullary carcinoma frequency in patients with type 2 diabetes.

“Careful surveillance for a rise in C-cell-associated disease will be the only chance to safely exclude this as a potential adverse outcome of treatment with incretin-based therapies,” he said.

However, there may be additional benefits of these therapies. Nauck highlighted data presented during another session by Bunck et al showing that 3-year treatment with exenatide led to significant improvements in beta cell function in 69 patients on a metformin regimen.

Moreover, there appears to be a beneficial effect of the presence of exanatide and liraglutide (Victoza, Novo Nordisk) on the heart muscle and blood vessels in mice, according to Nauck.

For more information:

• Nauck MA. GLP/DPP4. Presented at: 46th Annual European Association for the Study of Diabetes Annual Meeting; Sept. 20-24, 2010; Stockholm, Sweden.

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