FDA Approves New Diabetes Drug to Control Blood Sugar

The FDA has approved dulaglutide (Trulicity, Eli Lilly and Company), a once-weekly subcutanteous injection to improve glycemic control in adults with type 2 diabetes. The drug is to be used in combination with diet and exercise.

Trulicity, the glucagon-like peptide-1 (GLP-1) receptor agonist, was tested in 6 clinical trials of 3342 patients with type 2 diabetes. Participants reported reductions in HbA1c levels, resulting in an improvement in blood sugar control.
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Trulicity can be used as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin.

The drug is not approved to treat type 1 diabetes nor to be used on patients with diabetic ketoacidosis, severe stomach or intestinal problems, or as a first-line therapy when diet and exercise are not possible. A boxed warning notes that tumors of the thyroid gland were observed in rodent studies. The drug is not to be used in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

The most common side effects include nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.

—Pooja Shah

Reference:

FDA. FDA approves Trulicity to treat type 2 diabetes [press release]. 2014 Sep 8. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm415180.htm. Accessed September 22, 2014.