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FDA Approves Once-Weekly GLP-1 Diabetes Treatment Regimen for T2DM

Sep 25, 2014

Dulaglutide (Trulicity) is approved as a once-weekly injection for the treatment of type 2 diabetes….

Dulaglutide is a member of the glucagon-like peptide (GLP-1) receptor agonist class, along with liraglutide, exenatide, and albiglutide. The US Food and Drug Administration (FDA) has approved dulaglutide (Trulicity) as a once a week injection for the treatment of adults with type 2 diabetes.

See more GLP-1 Agonist Resources

FDA looked at six clinical trials to evaluate the safety and efficacy of dulaglutide in 3342 patients with diabetes. In these studies, dulaglutide was given alone or in combination with other diabetes medicines. Five of these studies were large, phase 3 clinical trials, which looked at the weekly administration of dulaglutide. The efficacy of Trulicity was compared to four commonly used type 2 diabetes medicines: metformin, Januvia, Byetta, and Lantus.

Overall, the studies showed that dulaglutide showed reduction in patients’ HbA1C levels. In rodent studies, dulaglutide caused thyroid C-cell tumors but it is unclear why so dulaglutide will have a box warning for patients with personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplastia syndrome type 2.

The most common side effects that were observed in clinical trials were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.
FDA is requiring more post-marketing studies for dulaglutide; to assess safety and efficacy in pediatric patients, to assess potential effects on sexual maturation, reproduction, and CNS development and function, medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to dulaglutide, a clinical trial to compare dulaglutide with insulin glargine on and moderate or severe renal impairment; and a trial to evaluate the cardiovascular risk of dulaglutide in patients with high baseline risk of cardiovascular disease.

Practice Pearls:

  • FDA has approved dulaglutide (Trulicity), a once-a-week injection for treatment of type 2 diabetes, as an adjunct to diet and exercise, concluded from six clinical trials.
  • Dulaglutide is contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2.
  • The starting dose for dulaglutide is 0.75 mg and can be increased to 1.5 mg.
  • Dulaglutide comes as a single dose pen that does not require mixing, measuring or needle attachment.
  • It is administered once a week, any time of the day, with or without food, injected subcutaneously in the abdomen, thigh, or upper arm.

“FDA Approves Trulicity to Treat Type 2 Diabetes.” U.S. Food and Drug Administration, 18 Sept. 2014. Web.>.