Pharmaceutical Business review

Positive phase III data for Merck diabetes drug

Additionally, treatment with Januvia improved measures of beta cell function. Beta cells are cells in the pancreas that make and release insulin. The data from the studies were presented at the American Diabetes Association annual scientific sessions.

Januvia is an investigational once-daily medicine that, if approved, would potentially be the first in a new class of oral drugs (dipeptidyl peptidase-4, or DPP-4, inhibitors) that enhances the body's own ability to lower blood sugar (glucose) when it is elevated. The mechanism of action of DPP-4 inhibitors is distinct from that of any currently available class of glucose-lowering agents.

An important predictive factor of the magnitude of A1C reduction in response to anti-hyperglycemic therapy is a patient's A1C level at baseline; A1C is a measure of a person's average blood glucose over a two- to three-month period. In these studies, the mean effect of Januvia on A1C levels was greater with higher baseline A1C levels.

“The data for Januvia presented today showed significant glucose-lowering effects across a range of patients with type 2 diabetes, especially in those with more elevated baseline A1C levels. In these studies, a low rate of hypoglycemia was observed and Januvia was generally weight neutral,” said Dr Edward Horton, vice president of the Joslin Diabetes Center in Boston and head of its clinical research division.