Lilly's AWARD-11 trial studying higher investigational doses of Trulicity® (dulaglutide) demonstrated superiority in A1C reduction in people with type 2 diabetes
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- Published on Thursday, 27 June 2019 09:45
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INDIANAPOLIS, IN. USA I June 26, 2019 I Eli Lilly and Company's (NYSE: LLY) 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.
About the AWARD-11 Study
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).
Indication and Limitations of Use for Trulicity®
Trulicity is a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. It should be used along with diet and exercise. Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas (pancreatitis). Trulicity should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe gastrointestinal (GI) disease. It is not a substitute for insulin. It has not been studied in children under 18 years of age.
Approximately 30 million Americans1 and an estimated 425 million adults worldwide have diabetes.2 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone.1 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.2
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes. We offer a wide range of therapies and a continued determination to provide real solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels. P-LLY
- Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2017.
- International Diabetes Federation. IDF Diabetes Atlas, 8th edn. Brussels, Belgium: International Diabetes Federation, 2017. http://www.diabetesatlas.org.
SOURCE: Eli Lilly