Trulicity(dulaglutide)

Trulicity (dulaglutide) is indicated in adults with type 2 diabetes mellitus to improve glycaemic control. It can be used as monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom metformin is inappropriate due to intolerance or contraindications. It is also indicated as add-on therapy in combination with other glucose-lowering medicinal products, including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Efficacy findings include a change from baseline in HbA1c of -0.78% and -0.71%. When compared to metformin, the HbA1c LS Mean Difference was -0.22% and -0.15%. Patients achieving a target HbA1c of <7.0% ranged from 53.6% to 62.6%. Body weight change from baseline ranged from -1.36 kg to -2.29 kg. Common safety findings include vomiting, with an incidence of 11.5% for Dula 1.5 mg and 9.2% for all Dula doses. Eructation incidence was 1.4% for both Dula 0.75 mg and Dula 1.5 mg, and 1.2% for all Dula doses. Syncope incidence was 0.4% for both Dula 1.5 mg and all Dula doses. Cataract incidence was 0.5% for Dula 0.75 mg and 0.4% for Dula 1.5 mg, compared to 1.1% for all comparators.

Trulicity received its initial marketing authorization in the US on 18 September 2014. The Marketing Authorisation application was submitted on 27 September 2013. The initial formulation strength was 1.5 mg, with an additional strength of 0.75 mg introduced later. The proposed posology for monotherapy is 0.75 mg once weekly, and for add-on therapy, it is 1.5 mg once weekly. The regulatory review included 30 completed clinical studies, 21 completed clinical pharmacology studies, 4 completed Phase 2 studies, and 5 completed Phase 3 studies.