Merck, Pfizer double size of diabetes study to catch rivals

Merck & Co and Pfizer Inc are doubling the size of a study of their joint diabetes treatment to keep up with smaller competitors in the fast-growing market that already have proven their drugs can reduce the risk of death from heart complications.

The pharmaceutical companies, the largest two in the US, are developing the drug ertugliflozin for use alone and in combination with Merck's best-selling Januvia. The trial will be expanded to 8,000 people at high risk for heart disease to determine whether the treatment helps the heart.

A study presented on Saturday at the American Diabetes Association meeting in New Orleans found that the drug significantly reduced glucose levels and helped more than half of patients reach their blood sugar goals in some cases.

While impressive, the study wasn't designed to evaluate the medicines' impact on heart disease, by far the leading cause of death in diabetics.

The competition heated up in the $71.5 billion global diabetes market last year after Eli Lilly & Co's and Boehringer Ingelheim GmbH's Jardiance unexpectedly reduced the risk of heart attacks, strokes and deaths by 14 per cent in a study, the first to show such a benefit. Novo Nordisk A/S said in March that its Victoza injections have a similar benefit.

The details of that study, called Leader, will be presented at the diabetes meeting on Monday. While blood sugar control is critical in diabetes, "even more important is reducing the complications, and arguably the most important is in cardiovascular outcomes," said James Rusnak, chief development officer for cardiovascular and metabolic drugs at Pfizer. "We are not only looking at the cardiovascular safety requirement for regulatory approval, we expect to further define the benefit of ertugliflozin to deliver the reduction of cardiovascular" complications and death, he said.