A new drug for type 2 diabetes that is taken once a week has performed well in terms of controlling blood sugar than other similar medicines, late stage clinical trials suggest. The drug known as dulaglutide being developed by pharmaceutical giant Eli Lilly also helped patients lose twice as much weight as some others, according to data presented at the American Diabetes Association (ADA) meeting in Chicago.
Experts believe that the weekly injection could be an important new weapon in the fight against type 2 diabetes, whose rapid growth globally has become a crisis affecting more than 300 million people. Dulaglutide belongs to a class of injected drugs known as GLP-1 receptor agonists that work by increasing the release of insulin after meals and by slowing absorption of food in the gastrointestinal tract.
‘I believe the use of GLP-1s will continue to increase and this new formulation of a once a week administration will be very attractive to patients and physicians,’ said Guillermo Umpierrez, a professor of medicine at Emory University in Atlanta who presented data from one of the trials at the meeting. ‘This is a very promising, safe and efficacious agent for the treatment of diabetes. Dulaglutide not only demonstrated superior glycaemic control in these Phase III trials, it provided this control with once weekly dosing, which may be attractive to both patients and healthcare professionals,’ he explained.
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The trials compared the drug to others and found that patients taking dulaglutide 1.5 mg showed sustained weight loss for the duration of the trials. Patients taking dulaglutide 1.5 mg showed significant weight loss compared to patients taking sitagliptin (AWARD-5), and showed similar weight loss to patients taking comparators in AWARD-1 and AWARD-3. Nausea was the most common adverse effect reported across the studies for dulaglutide and was mostly mild to moderate and transient. No new safety signals were seen in any of the studies.
Dulaglutide showed low rates of hypoglycaemia with blood glucose levels less than or equal to 70 mg/dL across these three AWARD trials. There were no cases of documented severe hypoglycaemia in any of the trials. ‘These results are a promising step forward in our effort to provide a new, once GLP-1 treatment option, giving patients another choice to help manage their diabetes,’ said Dr Sherry Martin, senior medical director, Lilly Diabetes.
‘Dulaglutide represents an important component of our diabetes portfolio, as it could help us offer a broader range of options to patients across the diabetes spectrum,’ added Martin. Dulaglutide is among several diabetes treatments currently in the late stage of development at the firm. The company has a number of potential new medicines in clinical development for the treatment of diabetes and its related conditions, encompassing both large and small molecules, and targeting a variety of mechanisms.
Lilly expects to submit dulaglutide to regulatory authorities in 2013 and to submit detailed data from two additional AWARD studies for presentation at scientific meetings in 2014.