Findings from a phase 3 study showed that dulaglutide (Trulicity; Lilly) at higher investigational doses demonstrated superiority in significantly reducing hemoglobin A1c in patients with type 2 diabetes (T2D).

The AWARD-11 trial is a 52 week, double-blind, parallel arm, phase 3 study of T2D patients (N=1842) evaluating the safety and efficacy of 2 investigational doses of dulaglutide (3mg and 4.5mg) compared with the approved dose of dulaglutide 1.5mg. Patients were randomized to receive either dulaglutide 1.5mg, 3mg, or 4.5mg once weekly titrated at 4 week intervals starting at a dose of 0.75mg. The primary objective of the study was to demonstrate the superiority of the investigational doses vs the approved dose on A1c reduction.

At week 36, the higher investigational doses of dulaglutide were found to be superior to dulaglutide 1.5mg in reducing A1c (primary endpoint) and for weight reduction (secondary endpoint). Regarding safety and tolerability, the higher investigational doses were consistent with the known profile of dulaglutide 1.5mg. 

The study is expected to be completed in late 2019, at which point the Company plans to submit to regulatory authorities and disclose detailed results at a future date.

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“Lilly chose to study additional doses of dulaglutide to provide more options for clinicians and people living with type 2 diabetes. said Brad Woodward, MD, global development leader, Incretins, Lilly. “We’re encouraged by the superior results, which showed a significant reduction in A1c beyond the effective Trulicity doses already available.”

Trulicity, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a once-weekly injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is supplied as a 0.75mg/0.5mL or 1.5mg/0.5mL pen or prefilled syringe for subcutaneous injection. 

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