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 was also approved for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular (CV) disease or multiple cardiovascular risk factors.
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.
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%.
The FDA approval of Trulicity for the reduction of MACE was based on REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes), a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of Trulicity 1.5 mg compared to placebo, both added to standard of care, on cardiovascular (CV) events in adults with type 2 diabetes. The primary CV outcome was the first occurrence of MACE (the composite of CV death or nonfatal myocardial infarction or nonfatal stroke). REWIND showed a significant risk reduction in MACE, a composite endpoint of nonfatal myocardial infarction (heart attack), nonfatal stroke or CV death. Results demonstrated consistent MACE risk reduction with Trulicity across major demographic and disease subgroups.
Adverse effects associated with the use of Trulicity may include, but are not limited to, the following:
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.
For additional information regarding Trulicity of the improvement of glycemic control in type II diabetics, please visit www.trulicity.com