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Novo Nordisk has suspended development of ragaglitazar - a drug that has potential for regulating both blood-glucose and lipid levels-after finding urine bladder tumors in one mouse and several rats tested with the drug during preclinical trials.
Current clinical trials have been halted, and planned new clinical trials have been suspended, according to a news release from the company.
"The tumors observed may prove to be specific for the rodent species and in that case, they will be of no relevance to humans," says Mads Krogsgaard Thomsen, chief science officer of Novo Nordisk. "However, we have for patient safety reasons decided to take a precautionary approach and stop the ongoing clinical trials while we investigate the preclinical findings in more detail."
Thomsen says it is too early to tell whether new clinical trials will be initiated. If they are, Thomsen expects a delay of about two years.
0 comments - Oct 1, 2002
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.