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ADA: Lilly's once-weekly diabetes drug bests Januvia and Byetta

Late-stage trials of dulaglutide show superiority over established brands

American Diabetes Association Chicago 2013

Lilly's investigational once-weekly type 2 diabetes drug dulaglutide has shown better blood sugar control than Merck & Co's Januvia (sitagliptin) and Byetta (exanatide) from Bristol-Myers Squibb.

The phase III trials, which were presented at the American Diabetes Association (ADA) meeting in Chicago over the weekend, also showed dulaglutide to have glycaemic benefits over the older treatment metformin.

“In all three cases we showed a significant and sustained glycaemic effect, so we were very pleased with the data,” a spokesman told PMLiVE. “[As] a once a week, ready to use injection it's going to be very convenient for the patient.”

Dulaglutide's phase III AWARD trial programme found the drug to be superior to all three comparators at reducing HbA1c levels and a higher percentage of patients on Lilly's drug achieved an HbA1c goal of less than 7 per cent (the level the ADA recommends).

Lilly was also able to show significant weight loss compared to patients on Januvia, and similar weight loss levels to those taking Byetta or metformin.

The company said there were no cases of severe hypoglycaemia in any of the trials and no new safety signals were seen in any of the studies of its GLP-1 receptor agonist.

The safety profile of the drug is particularly important, given that regulators are already investigating the safety of both GLP-1s (like Byetta) and DPP-4 inhibitors (like Januvia).

The company plans to submit dulaglutide to regulatory authorities in 2013 and will submit detailed data from two further AWARD studies next year.

“We think it is going to be an important part of our diabetes portfolio,” the spokesman said. “We try to take a broad approach to the treatment of diabetes and the needs of the diabetic patient and we think dulaglutide will be an important component piece of that.”

Article by
Dominic Tyer

26th June 2013

From: Research



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