Bristol, Astra's Onglyza controls diabetes: trial

LOS ANGELES, 08 june 2009– An interim look at a long-term study of Onglyza, under development by Bristol-Myers Squibb Co and AstraZeneca Plc, continued to show lowered glucose levels when used in combination with metformin in people with type 2 diabetes.

Data released on Saturday at a meeting of the American Diabetes Association, also showed that side effects were consistent with earlier trial results.

The companies are awaiting U.S. and European regulatory approval for Onglyza, or saxagliptin, a member of a class of diabetes drugs known as DPP-4 inhibitors.

The latest trial results were from the 102-week mark in an ongoing extension study involving 743 patients that will last 42 months.

The interim analysis showed that adverse events occurred in 89.6 percent of patients given saxagliptin at 2.5 mg plus metformin, 78 percent for saxagliptin at 5 mg plus metformin and 86.7 percent for saxagliptin 10 mg plus metformin. The incidence of adverse events was 78.8 percent for placebo plus metformin.

Between 13.6 percent and 22.7 percent of Onglyza-treated patients had skin-related side effects, compared with 11.2 percent of the placebo patients.

The most commonly reported side effects included inflammation of the nasal passages, influenza, upper respiratory tract infection and urinary tract infection.

The companies said between 51.8 percent and 58.3 percent of the Onglyza-treated patients discontinued the study, compared with 71.5 percent of placebo patients.

After 102 weeks, levels of hemoglobin A1C, a measure of glucose control, dropped between 0.52 percent and 0.72 percent for patients in the Onglyza treatment groups, the companies said.