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September 18, 2014 – We learn today from the U.S. Food and Drug Administration (FDA) of the approval of Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects about 26 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
“Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal,” said Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “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.”
Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist (also known as incretin mimetics). GLP-1 is a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type 2 diabetes received Trulicity. Patients receiving Trulicity had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control). Trulicity has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. Trulicity should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); those with severe stomach or intestinal problems; or as first-line therapy for patients who cannot be managed with diet and exercise.
Trulicity has a boxed warning that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with Trulicity but that it is unknown whether Trulicity causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Trulicity should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (a disease in which patients have tumors in more than one gland in their body, which predisposes them to MTC). In clinical trials, the most common side effects observed in patients treated with Trulicity were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.
The FDA is requiring the following post-marketing studies for Trulicity:
- a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients;
- a study to assess potential effects on sexual maturation, reproduction, and CNS development and function in immature rats;
- a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Trulicity;
- a clinical 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.
The FDA approved Trulicity with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Trulicity.