Regulatory Decision Summary for Trulicity

The decision to authorize a new indication was based on the results of Study H9X-MC-GBDJ (REWIND): Trulicity (dulaglutide) 1.5 mg administered subcutaneously once weekly was superior to placebo in reducing the cardiovascular risk in adult patients with type 2 diabetes mellitus. Results were driven by the non-fatal stroke events. A number of 9,901 patients, with multiple cardiovascular risk factors or established cardiovascular disease, were recruited in this trial where the median follow-up duration was 5.4 years.

The incidence of adverse events was similar for patients who received Trulicity or placebo. The most frequently reported adverse events for Trulicity were nausea, diarrhea, and urinary tract infection. Severe hypoglycemia occurred at small and similar rates in the treatment and placebo groups. No differences between the treatment groups were observed in the incidence of other adverse events of interest. The safety profile for patients treated with dulaglutide in study REWIND was consistent with the safety profile reflected in the current Canadian Product Monograph. No new safety concerns were identified in this study.

Based on the efficacy results from study REWIND, which demonstrated cardiovascular benefit, as well as the consistent safety profile, the benefit-risk profile of Trulicity at the recommended dosing regimen remains positive in the target patient population.

Accordingly, Health Canada authorised a new, cardiovascular risk reduction indication for Trulicity in adult patients with type 2 diabetes mellitus.