Lilly Phase III diabetes boost
pharmafile | April 17, 2013 | News story | Research and Development, Sales and Marketing | diabetes, dulaglutide, lilly
Eli Lilly and Co’s new type II diabetes candidate dulaglutide – which it intends to file this year – has performed well in two new Phase III trials, the manufacturer says.
The investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist is being studied as a once-weekly treatment for the disease.
Lilly already has a once-weekly drug in this relatively new class of injectable treatments – designed to help patients reduce blood sugar (HbA1c) levels after they have failed on oral treatments and short and long-acting insulin products – Bydureon (exenatide), which is a long-acting form of Byetta.
Its Phase III diabetes pipeline also includes novel basal insulin analogue LY2605541 and sodium glucose co-transporter-2 (SGLT 2) empagliflozin.
In two studies, AWARD-2 and AWARD-4, dulaglutide met primary efficacy endpoints of non-inferiority to insulin glargine, as measured by reduction of HbA1c levels.
Dulaglutide 1.5 mg demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine at 52 weeks in type II diabetes patients on metformin and glimeperide (AWARD-2).
Meanwhile, dulaglutide 1.5 mg with insulin lispro demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine with insulin lispro at 26 weeks (AWARD-4).
The most frequently reported adverse events were gastrointestinal-related.
The results join topline data from the other completed Phase III AWARD trials – AWARD-1, AWARD-3 and AWARD-5 – released last October showing that primary efficacy endpoints around the reduction in HbA1c at the 1.5 mg dose were also met.
“The results of our Phase III dulaglutide trials are encouraging and we look forward to sharing more details on the AWARD studies at upcoming scientific meetings,” said Enrique Conterno, president of Lilly Diabetes.
Diabetes is a highly competitive therapy area, with around 370 million people thought to suffer from type I or – in at least 90% of cases – type II diabetes.
Earlier this year GlaxoSmithKline filed its own GLP-1 receptor agonist albiglutide with European regulators, which is intended as a rival to Lilly’s Bydureon.
Novo Nordisk’s once-daily GLP-1 analogue Victoza (liraglutide) is among the key drugs in the market.
Adam Hill
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