Another glucagon-like peptide-1 drug, dulaglutide (Trulicity), is now approved for treating type 2 diabetes, .
The agent is given once-weekly by subcutaneous injection and should be used in conjunction with diet and exercise aimed at reducing blood sugar. It may be used with other drugs including metformin, sulfonylurea agents, thiazolidinediones, and/or prandial insulin, the agency said, but should not be considered for first-line drug therapy.
Some in the field had looked to once-weekly treatments as a way to improve adherence to therapy, but that hope has been called into question. Two other once-weekly GLP-1 agonists, Bydureon (exenatide) and Tanzeum (albiglutide), are currently available.
The leading GLP-1 agonist, Victoza (liraglutide), is given daily. These agents also compete with several drugs in the so-called gliptin class.
Dulaglutide's safety and effectiveness were established in six clinical trials with a total of 3,342 patients receiving the drug. The main evidence of efficacy was a reduction in HbA1c levels.
Contraindications include type 1 diabetes, severe gastrointestinal conditions, and diabetic ketoacidosis. The drug will include a boxed warning about risk of thyroid C-cell tumors that emerged in rodent studies. Dulaglutide should be avoided in patients with a personal or family history of medullary thyroid carcinoma and in patients with multiple endocrine neoplasia syndrome, the FDA said.
Five postmarketing studies were ordered by the agency. They include a pediatric safety and efficacy trial, a head-to-head trial with insulin glargine in adults, a cardiovascular outcomes study, an animal study to evaluate certain other risks, and a registry to establish risks for medullary thyroid carcinoma.
The drug is marketed by Eli Lilly.