The FDA has approved dulaglutide (Trulicity) — a once-weekly subcutaneous injection — as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes, according to a press release from the agency.
Dulaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, was evaluated in six clinical trials in which it was administered to 3,342 patients with type 2 diabetes. Results linked the drug to decreases in HbA1c, suggesting it improved blood sugar control.
Nausea, diarrhea, vomiting, abdominal pain and decreased appetite were the most commonly observed side effects.
Researchers have investigated dulaglutide as a standalone therapy as well as in conjunction with other treatments for type 2 diabetes, including metformin, sulfonylurea, thiazolidinedione and prandial insulin, according to the release.
Dulaglutide should not be used in patients with type 1 diabetes, those with diabetic ketoacidosis, severe stomach or intestinal problems or as first-line therapy in those who cannot control their diabetes with diet and exercise.
“Trulicity is a new treatment option, which can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of type 2 diabetes,” Mary Parks, MD, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in the release.
The drug also carries a boxed warning noting that thyroid C-cell tumors have been found in rodent studies with dulaglutide, although data have not firmly established a relationship between the treatment and thyroid C-cell tumors, including medullary thyroid carcinoma, in humans. Patients with a personal or family history of medullary thyroid cancer or those with multiple endocrine neoplasia syndrome type 2, should not receive dulaglutide.
The FDA is requiring several post-marketing studies for dulaglutide:
- A clinical trial evaluating dosing, efficacy and safety in pediatric patients
- A study assessing potential effects on sexual maturation, reproduction and CNS development and function in immature rats
- A medullary thyroid carcinoma case registry of at least 15 years duration to identify any increase in the condition related to dulaglutide
- A clinical trial comparing dulaglutide with insulin glargine for glycemic control in patients with type 2 diabetes and moderate or severe renal impairment
- A cardiovascular (CV) outcomes trial evaluating the CV risk of dulaglutide in patients with high baseline risk for CVD
The FDA approved dulaglutide with a Risk Evaluation and Mitigation Strategy (REMS). It includes a
Dulaglutide, which will be marketed as Trulicity, is manufactured by Indianapolis-based Eli Lilly and Company.