Onglyza is indicated as a once daily drug and can be used in combination
with commonly prescribed oral anti-diabetic medications – metformin,
sulfonylureas or thiazolidinediones – or as a monotherapy to significantly
reduce glycosylated hemoglobin levels.
The companies added that Onglyza should not be used for the treatment of
type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of
certain acids, known as ketones, in the blood or urine). Onglyza has not been
studied in combination with insulin.
The FDA approval is based on a clinical development program, which included
approximately 5,000 individuals, more than 4,000 of whom received Onglyza.
