RE:Dulaglutide The drug will come with a boxed warning raising links between the treatment and tumors found in the thyroid glands in rodents. And Eli Lilly will be on the hook for a range of post-marketing studies, including:
- A study to evaluate dosing, efficacy, and safety in pediatric patients.
- A study on its effects regarding sexual maturation, reproduction, and CNS development and function in immature rats.
- A trial comparing Trulicity with insulin glargine on glycemic control in patients with type 2 diabetes and moderate or severe renal impairment,
- And a cardiovascular outcomes trial to evaluate the cardiovascular risk of Trulicity in patients with high baseline risk of cardiovascular disease.
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