Lilly's Once-Weekly Dulaglutide Shows Non-Inferiority to Liraglutide in Head-to-Head Phase III Trial for Type 2 Diabetes
Eli Lilly and Company has announced positive top-line results of the sixth AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) trial for once-weekly dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a treatment for type 2 diabetes.
In the AWARD-6 study, once-weekly dulaglutide 1.5 mg achieved the primary endpoint of non-inferiority to once-daily liraglutide 1.8 mg, as measured by the reduction of hemoglobin A1c (HbA1c) from baseline at 26 weeks.
"Dulaglutide is the only GLP-1 agonist to show non-inferiority against liraglutide's highest-approved dose in a Phase III trial," said Enrique Conterno, president of Lilly Diabetes. "The AWARD-6 data, along with the previous five AWARD studies, give us confidence that dulaglutide can be an important treatment option for people with type 2 diabetes. If approved, dulaglutide would be the only GLP-1 agonist that is both once-weekly and ready-to-use."
Adverse events were similar for patients in both treatment groups. The most frequently reported events were gastrointestinal-related. These findings are consistent with prior studies of once-weekly dulaglutide.
Once-weekly dulaglutide has been submitted to FDA, EMA and other regulatory bodies. All previous five AWARD trials (1–5) included demonstrated superiority in reduction of HbA1c at the 1.5 mg dose against placebo and active comparators.
Lilly plans to present detailed data from the AWARD-6 (dulaglutide vs. liraglutide), AWARD-2 (dulaglutide vs. insulin glargine), and AWARD-4 (dulaglutide vs. insulin glargine; both in combination with insulin lispro) studies at scientific meetings later this year.
Related News
-
News CPHI Frankfurt 2022: Innovator Interview – DSM Biomedical
At CPHI Frankfurt we spoke to Anne-Cecile Bayne, Global Science & Innovation Lead Pharma and Medical Nutrition, and Marc Hendriks, Vice President Strategy & Business Development, on their expertise in nitrosamines and business strategy at DSM Biomedica... -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled. -
News Magic mushrooms could be used to treat mental health conditions
A compound found in magic mushrooms, psilocybin, could be used to treat mental health conditions and help patients suffering with severe depression, as shown by the results of the largest study of its kind to date. -
News UK-based partnership to launch DETERMINE study into rare cancer research
UK-based CRO Quanticate is set to partner with Cancer Research UK for the launch of the DETERMINE study focused on testing a range of existing and approved drugs and therapies on rare cancers. -
News FDA approves Thermo Fisher blood tests for wheat and sesame allergies
Both tests have been approved by the US regulator for in vitro diagnostic use -
News QIAGEN launches world’s first syndromic test for monkeypox
The test can distinguish between monkeypox and other diseases that cause similar symptoms. -
News Monkeypox Update: Vaccine shortage, sewage surveillance and global testing
As concern over the monkeypox outbreak continues to rise, we take a look at major developments from the first week of August. -
News CPHI Podcast Series: The importance of novel excipients for innovative drug development
The latest episode in the CPHI Podcast Series dives into the world of novel excipients and explores their importance for innovative drug development.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance