Lilly's Trial Studying Higher Doses of Trulicity® (dulaglutide) Meets Primary Endpoint

Eli Lilly and Company's trial studying higher investigational doses of Trulicity® (dulaglutide) met its primary efficacy endpoint of superiority, significantly reducing A1C from baseline in people with type 2 diabetes, compared to once-weekly Trulicity 1.5 mg after 36 weeks. The trial also met the secondary efficacy endpoint for superiority on weight reduction. The safety and tolerability profile of the investigational dulaglutide doses was consistent with the known profile of Trulicity 1.5 mg.

AWARD-11, a phase 3 randomized, double-blind, parallel arm study, evaluated the safety and efficacy of dulaglutide 3.0 mg and 4.5 mg doses in 1,842 participants with type 2 diabetes.

"Diabetes is a progressive condition, which is why people may need to adjust their treatment to achieve further glycemic control," said Brad Woodward, M.D., global development leader, Incretins, Lilly. "Lilly chose to study additional doses of dulaglutide to provide more options for clinicians and people living with type 2 diabetes. We're encouraged by the superior results, which showed a significant reduction in A1C beyond the effective Trulicity doses already available."

The AWARD-11 trial will continue through 52 weeks to evaluate longer-term safety data and is expected to complete in late 2019. Lilly plans to submit to regulatory authorities by late 2019 and will share detailed results at a future date.

The phase 3, randomized, double-blind, parallel arm study included 1,842 participants with type 2 diabetes and evaluated the efficacy and safety of two investigational doses of dulaglutide (3.0 mg and 4.5 mg) compared to dulaglutide 1.5 mg. The primary objective of the study was to demonstrate that a once-weekly investigational dulaglutide dose (3.0 mg and/or 4.5 mg) was superior to the approved Trulicity 1.5 mg dose, as measured by A1C reduction from baseline, at 36 weeks in people with inadequately controlled type 2 diabetes on concomitant metformin therapy. The primary and secondary objectives could be met if one or both doses achieved statistical significance for A1C reduction. Secondary and exploratory outcomes include change in mean body weight, percentage of A1C reductions less than seven percent, fasting plasma glucose (FPG) and occurrence of hypoglycemic episodes through 36 and 52 weeks. All patients started the study at a dose of dulaglutide 0.75 mg and then increased the dose in a step-wise approach at four week intervals to their final randomized maintenance dose of 1.5 mg, 3.0 mg (via a 1.5 mg step), or 4.5 mg (via steps at 1.5 mg and 3.0 mg).

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