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FDA Approves Trulicity to Treat Type-2 Diabetes
The FDA has approved dulaglutide (Trulicity, Eli Lilly and Company), a once-weekly subcutaneous injection to improve glycemic control 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% 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.
Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, 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 dulaglutide. Patients receiving dulaglutide had an improvement in blood sugar control (based on reductions in hemoglobin A1c).
Dulaglutide has been studied as monotherapy and in combination with other type-2 diabetes therapies, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. Dulaglutide should not be used to treat people with type-1 diabetes; those who have 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 thyroid C-cell tumors have been observed in rodent studies with dulaglutide, but it is not known whether dulaglutide causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Dulaglutide should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (which predisposes patients to MTC).
The FDA is requiring the following post-marketing studies for dulaglutide:
- A clinical trial to evaluate dosing, efficacy, and safety in pediatric patients
- A study to assess potential effects on sexual maturation, reproduction, and central nervous system development and function in immature rats
- An MTC case registry of at least 15 years’ duration to identify any increase in MTC incidence 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 outcomes trial to evaluate the cardiovascular risk of dulaglutide 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 dulaglutide. In clinical trials, the most common side effects observed in patients treated with dulaglutide were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.
Lilly plans to make Trulicity 0.75-mg and 1.5-mg single-dose injection pens available for adults in the United States later this year. The recommended starting dose of 0.75 mg can be increased to a 1.5-mg dose for patients who need additional blood sugar control. The pen does not require mixing, measuring, or needle attachment.