New 36-week data showed higher investigational doses of Trulicity (3 mg and 4.5 mg) were well-tolerated and led to A1C reductions up to 1.9 percent and weight reductions up to 10.4 pounds in people with type 2 diabetes. The results from Eli Lilly and Company's (NYSE:LLY) AWARD-11 trial – which evaluated the safety and efficacy of higher investigational doses of Trulicity (3 mg and 4.5 mg) compared to Trulicity 1.5 mg – were published late today in the Journal of the Endocrine Society.
"AWARD-11 confirmed our expectations that a higher investigational dose of Trulicity would lead to superior blood glucose and weight reductions in people with type 2 diabetes compared to Trulicity 1.5 mg," said Juan Pablo Frias, M.D., Medical Director and Principal Investigator, National Research Institute. "These promising data show higher doses of dulaglutide could be an option for clinicians treating people with type 2 diabetes who may need additional glycemic control due to the progressive nature of the condition."
The 4.5 mg dose led to statistically superior A1C reductions from baseline compared to Trulicity 1.5 mg across two primary statistical approaches – efficacyi and treatment-regimenii estimands – that were used to assess the efficacy of the higher doses.
Using the efficacy estimand, which analyzes participants who remained on treatment, dulaglutide 3 mg and 4.5 mg led to significantly superior A1C and weight reductions from baseline compared to Trulicity 1.5 mg:
(baseline 8.6 percent)
[baseline 211.4 lbs. (95.9 kg)]
dulaglutide 4.5 mg
-10.4 lbs. (-4.7 kg)*
dulaglutide 3 mg
-8.8 lbs. (-4.0 kg)*
Trulicity 1.5 mg
-6.8 lbs. (-3.1 kg)
*Denotes statistical significance compared to Trulicity 1.5 mg
In the treatment-regimen estimand, each of the doses led to significant A1C and body weight reductions but only the 4.5 mg dose showed superiority compared to Trulicity 1.5 mg:
- A1C reduction: -1.8 percent (dulaglutide 4.5 mg), -1.6 percent (dulaglutide 3 mg) and -1.5 percent (Trulicity 1.5 mg).
- Weight reduction: -10.1 pounds (-4.6 kg, dulaglutide 4.5 mg), -8.4 pounds (-3.8 kg, dulaglutide 3 mg) and -6.6 pounds (-3.0 kg, Trulicity 1.5 mg).
Across both estimands, the majority of study participants achieved target A1C goals of less than seven percent with the higher investigational doses – meeting the American Diabetes Association's recommendation for people with diabetes.
The safety and tolerability profile of the investigational dulaglutide doses (3 mg and 4.5 mg) was consistent with the known profile of Trulicity 1.5 mg. The most commonly reported adverse events across each of the doses were gastrointestinal-related.
"Diabetes is a complex condition that progresses over time and may require additional treatments to maintain blood glucose control. That's why we studied higher doses of Trulicity, the most prescribed GLP-1 receptor agonist in the U.S.," said Dawn Brooks, Ph.D., global development leader, Trulicity, Lilly. "We are encouraged by these data and the potential to provide people living with type 2 diabetes who may need to advance their treatment with options that build on their established experience with Trulicity."
Results at 52-weeks were consistent with the 36-week results and further details will be disclosed at a later date. The AWARD-11 results have been submitted to regulatory authorities in the U.S. and Europe for review.