LOS ANGELES, June 7 (Reuters) - Takeda Pharmaceutical Co Ltd’s (4502.T) experimental diabetes drug alogliptin significantly lowers blood sugar alone and in combination with other common therapies, according to research presented on Saturday.
Data from five pivotal clinical trials of the drug, part of a new class known as DPP-4 inhibitors, was unveiled at a meeting in San Francisco of the American Diabetes Association.
“What’s really important about alogliptin is the breadth and depth of the studies,” said Dr. Robert Spanheimer, vice president, medical scientific affairs at Takeda. “No other DPP-4 inhibitor has been studied so broadly.”
Dipeptidyl peptidase-4, or DPP-4, inhibitors like Merck and Co Inc’s (MRK.N) Januvia and alogliptin work to enhance the body’s ability to lower elevated levels of blood sugar.
Takeda said alogliptin, given once daily, demonstrated statistically significant reductions in hemoglobin A1c (a measure of an individual’s average blood sugar over three months) versus placebo alone and as an add-on therapy with the major classes of type 2 diabetes medications: metformin, thiazolidinediones, insulin and sulfonylureas.
Abstracts of the trial results were released prior to the diabetes conference.
Spanheimer said Takeda is evaluating its options for combining alogliptin in a single pill with other oral drugs, noting that the company has already launched a Phase III trial of a pill combining alogliptin with Actos.
Japan’s largest drug maker has grown globally on the strength of its diabetes pill Actos, which has annual sales of more than $3 billion but will lose U.S. patent protection in 2011.
Actos and rival medicine Avandia from GlaxoSmithKline (GSK.L) are “insulin sensitizers,” belonging to a class of drugs called thiazolidinediones or TZDs, that help lower insulin resistance.
Spanheimer said there were no surprises as far as side effects in the alogliptin trials, with headache and swelling being some of the most common adverse events.
The company expects a decision later this year from the U.S. Food and Drug Administration on its application to sell the drug. (Reporting by Deena Beasley; Editing by Eric Walsh)