Eli Lilly and Company has reported that the AWARD-11 Phase III trial of Trulicity (dulaglutide) met its primary efficacy endpoint of superiority, significantly reducing A1C from baseline in people with type 2 diabetes.
The trial is studying higher investigational doses of Trulicity compared to once-weekly Trulicity 1.5mg after 36 weeks.
Additionally, the trial met the secondary efficacy endpoint for superiority on weight reduction.
The safety and tolerability profile of Trulicity doses was found to be consistent with the known profile of Trulicity 1.5mg.
The randomised, double-blind, parallel arm AWARD-11 trial investigated 1,842 participants with type 2 diabetes and evaluated the efficacy and safety of 3mg and 4.5mg doses of dulaglutide compared to dulaglutide 1.5mg.
Eli Lilly and Company Incretins global development leader Brad Woodward said: “Diabetes is a progressive condition, which is why people may need to adjust their treatment to achieve further glycemic control.
“Lilly chose to study additional doses of dulaglutide to provide more options for clinicians and people living with type 2 diabetes.”
The study’s primary objective was to demonstrate that a once-weekly investigational dulaglutide dose was superior to the approved Trulicity 1.5mg dose.
In the trial, all patients started the study at a dose of dulaglutide 0.75mg. The dose was later on increased in a step-wise approach at four-week intervals to their final randomised maintenance dose of 1.5mg, 3mg, or 4.5mg.
The AWARD-11 trial will continue for 52 weeks to evaluate the longer-term safety data of Trulicity and is expected to be completed late this year.
Trulicity is a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.