Lilly's Higher-Dose Trulicity (Dulaglutide) Achieves Superior Glycemic Control and Weight Reduction in Phase 3 AWARD-11 Trial
Jun 27, 2019 10:12
CST Updated
10:12
Eli Lilly
Global Pharmaceutical R&D and Production Company
June 27, 2019 News /Bio ValleyBIOON/ -- U.S. pharmaceutical giantEli Lilly(Eli Lilly) recently announced the evaluation of high-dose Trulicity (dulaglutide) for the treatment of type 2DiabetesThe Phase III study AWARD-11 met its primary efficacy endpoint of superiority.
AWARD-11 was a randomized, double-blind, parallel-group Phase III study that enrolled a total of 1,842 patients with type 2DiabetesIn patients, the safety and efficacy of two investigational doses of Trulicity (3.0 mg and 4.5 mg, administered once weekly) were evaluated against the 1.5 mg dose (administered once weekly). The primary objective of the study was to demonstrate that, in patients with type 2 diabetesDiabetesAmong the patients, the glucose-lowering efficacy of the once-weekly investigational dose administered for 36 weeks was superior to that of the approved 1.5 mg dose. Secondary and exploratory endpoints included mean body weight change, the proportion of patients with glycated hemoglobin (A1C) <7%, fasting plasma glucose (FPG), and the incidence of hypoglycemia during the 36-week and 52-week treatment periods.
The results showed that after 36 weeks of treatment, higher once-weekly doses of Trulicity (3.0 mg and 4.5 mg) significantly reduced patients’ blood glucose levels (A1C) from baseline compared with the once-weekly 1.5 mg dose of Trulicity. Furthermore, the study met its secondary efficacy endpoint demonstrating superiority in weight reduction. In this study, the safety and tolerability profile of the investigational higher doses of Trulicity was consistent with the known safety and tolerability profile of the 1.5 mg dose of Trulicity.
The study will continue through Week 52 to assess long-term safety data and is expected to be completed by the end of 2019.Eli LillyThe report is planned to be submitted to regulatory authorities by the end of 2019, with detailed results to be shared in the future.
Dr. Brad Woodward, Global Development Leader for Incretins at Eli Lilly, stated: “DiabetesIt is a progressive disease, which is why people may need to adjust their treatment to further control blood sugar.Eli Lilly“Selecting to study an additional dose of Trulicity provides more options for clinicians and patients with type 2 diabetes. We are encouraged by the superiority results in this study, which demonstrated a significant reduction in A1C that exceeded those achieved with currently approved doses.”
Early this month,Eli LillyAt the 79th Scientific Sessions of the American Diabetes Association (ADA)MeetingDetailed data from the REWIND cardiovascular outcomes study were published. The results showed that, compared with placebo, Trulicity reduced major adverse cardiovascular events (MACE-3: non-fatalMyocardial Infarction[Myocardial infarction], non-fatal stroke, and cardiovascular death) risk was significantly reduced by 12%, with consistent MACE effects in patients with or without CV disease. Throughout the study, CV risk continued to decrease.
Based on the study results, Trulicity is the first type 2 diabetes medication to significantly reduce MACE events in a patient population where most participants had cardiovascular (CV) risk factors but no established CV disease. Adding Trulicity to type 2 diabetes treatment regimens will benefit a broad population.
Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist (RA), administered once weekly, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
GLP-1 RAs are a highly prominent class of medications in diabetes treatment. GLP-1 RAs are not insulin; rather, they are a novel class of insulin secretagogues. Their mechanism of action is similar to that of the endogenous hormone GLP-1, promoting the body’s own insulin secretion in response to food intake, thereby offering potent glucose-lowering efficacy and a lower risk of hypoglycemia, while also havingWeight LossEfficacy and the Advantage of Cardiovascular Benefits.
In the GLP-1 RA sector, Novo Nordisk’s Victoza (liraglutide) is currently the best-selling product, with global sales reaching $3.861 billion in 2018,Eli LillyTrulicity’s sales amounted to $3.199 billion. However, the industry believes that Trulicity is poised to surpass Victoza in the coming years and become the leading agent in the GLP-RA class. (Bioon.com)