The Food and Drug Administration (FDA) has approved Trulicity (dulaglutide; Eli Lilly) pen as adjunct to diet and exercise to improve glycemic control in in adults with type 2 diabetes.

Dulaglutide, a human glucagon-like peptide-1 (GLP-1) receptor agonist, activates GLP-1 receptors that are coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. It also decreases glucagon secretion and slows gastric emptying.

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The approval was based on five Phase 3 clinical trials from the AWARD clinical program that evaluated Trulicity used alone or in combination with commonly prescribed diabetes medications, including metformin, pioglitazone, glimepiride, and insulin lispro.

Trulicity pen is approved for once-weekly dosing and does not require the patient to mix, measure, or handle the needle. Trulicity will be available in 0.75mg and 1.5mg strength single-dose pens in 4-count cartons. It is expected to launch later this year.

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