Dulaglutide [Trulicity], a glucagon-like peptide-1 (GLP-1) receptor agonist, approved for the treatment of type 2 diabetes

Last Updated on

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.

Diabetes“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.

Tags: , , , , ,
About the Author
Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Your opinion

Comment

No comments yet

thasso: conditions

thasso: newest tweets

thasso: recent comments

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • Spatial mapping method pinpoints potential new therapeutic targets in lupus July 8, 2020
    A team of researchers from Children's Hospital of Philadelphia (CHOP) used a new method of pinpointing potential disease-causing changes in the genome to identify two new potential therapeutic targets for lupus, while also paving the way for more accurately identifying disease-causing variations in other autoimmune disorders. The findings were published online in Nature Communications.
  • New clues to lung-scarring disease may aid treatment July 8, 2020
    Scientists at Vanderbilt University Medical Center (VUMC) and the Translational Genomics Research Institute (TGen) in Phoenix, Arizona, have discovered previously unreported genetic and cellular changes that occur in the lungs of people with pulmonary fibrosis (PF).
  • Abnormal cells in early-stage embryos might not preclude IVF success July 8, 2020
    The presence of an abnormal number of chromosomes in the genetic profile of early-stage embryos may be far more common—and potentially less threatening—during normal human development than is currently appreciated, according to new research from Johns Hopkins University biologists.
  • Huntington disease brain changes ID'd 24 years before symptoms July 8, 2020
    (HealthDay)—The earliest brain changes due to Huntington disease (HD) can be detected in cerebrospinal fluid (CSF) 24 years before clinical symptoms show, according to a study published in the June 1 issue of The Lancet Neurology.
  • Metabolomics meets genomics to improve patient diagnosis July 7, 2020
    A patient and family walk into a doctor's office. They hope that the latest tests will reveal what is causing the patient's illness and end the diagnostic odyssey they have been going through for years. Having an accurate diagnosis also means that maybe there is a treatment that at least can alleviate the patient's condition.
Top