Trulicity (dulaglutide)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved September 2014

Specific Treatments:

To improve glycemic control in type II diabetics

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General Information

Trulicity (dulaglutide) is a glucagon-like peptide (GLP-1) receptor agonist. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.

Trulicity is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Trulicity is supplied as a solution for subcutaneous injection. The recommended initiating dose is 0.75 mg once weekly. The dose may be increased to 1.5 mg once weekly for additional glycemic control. The maximum recommended dose is 1.5 mg once weekly. Administer Trulicity once weekly, any time of day, with or without food. Trulicity should be injected subcutaneously in the abdomen, thigh, or upper arm.

Clinical Results

FDA Approval

The FDA approval of Trulicity was based on a 52-week double-blind study (26 week primary endpoint). The study enrolled 807 patients inadequately treated with diet and exercise, or with diet and exercise and one anti-diabetic agent used at submaximal dose. The subjects were randomized to Trulicity 0.75 mg once weekly, Trulicity 1.5 mg once weekly, or metformin 1500 to 2000 mg/day following a two week washout. Treatment with Trulicity 0.75 mg and 1.5 mg once weekly resulted in reduction in HbA1c from baseline at the 26 week primary timepoint. The difference in observed effect size between Trulicity 0.75 mg and 1.5 mg, respectively, and metformin excluded the pre-specified non-inferiority margin of 0.4%.

Side Effects

Adverse effects associated with the use of Trulicity may include, but are not limited to, the following:

  • nausea
  • diarrhea
  • vomiting
  • abdominal pain
  • decreased appetite

 

 

Mechanism of Action

Trulicity (dulaglutide) is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.

Additional Information

For additional information regarding Trulicity of the improvement of glycemic control in type II diabetics, please visit www.trulicity.com