On September 18, the US Food and Drug Administration (FDA) approved the once-weekly injectable Type 2 diabetes medicine dulaglutide (brand name Trulicity), developed by Eli Lilly and Company. Trulicity is a new member of the class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. (Exenatide [Byetta and Bydureon], liraglutide [Victoza], and albiglutide [Tanzeum] are the other members of this drug class.)
GLP-1 agonists work by stimulating the insulin-producing beta cells of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependent mechanism of action, drugs of this class are associated with a low rate of hypoglycemia (low blood glucose).
Trulicity, which is approved for use in conjunction with diet and exercise in adults with Type 2 diabetes, is administered via a single-dose injector pen that does not require mixing, measuring, or needle attachment. The safety and effectiveness of Trulicity were established through six clinical trials, involving 3,342 people with Type 2 diabetes, that showed improvements in A1C levels (a measure of blood glucose control over the previous 2—3 months) in those taking the drug.
The medicine will be offered in 0.75-milligram and 1.5-milligram doses to be taken once weekly, with or without food. (The recommended starting dose is 0.75 milligrams, which can be increased to 1.5 milligrams for those needing additional blood glucose control.) Trulicity is approved for use alone or in combination with metformin (Glucophage and others), glimepiride (Amaryl), pioglitazone (Actos), and insulin lispro (Humalog), and it should be injected into the abdomen, thigh, or upper arm.
The label carries a warning stating that certain types of thyroid tumors have been observed in rodent studies of Trulicity, but that it is not known whether the medicine causes such tumors in humans. The drug should not be used in people with a personal or family history of medullary thyroid cancer or in those who have Multiple Endocrine Neoplasia syndrome type 2.
The manufacturer will be conducting post-marketing trials focusing on the use of Trulicity in children, the potential effects of the drug on the reproductive and central nervous systems in young rats, the incidence of thyroid cancer in people using the medicine, the effectiveness of the medicine compared to insulin glargine (Lantus) in treating people with Type 2 diabetes and moderate or severe kidney impairment, and the heart risk for people using the medicine.
Trulicity should not be used to treat Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), or those with severe stomach or intestinal problems, nor should it be used as a first-line therapy in people who cannot control their condition with diet and exercise alone.
The most common side effects in people using this medicine are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.
Lilly plans to make Trulicity pens available in the United States later in 2014.
For more information, see the press releases on the Lilly and FDA websites.