Januvia Shown Effective in Treating Type 2

According to data from a number of studies presented at the American Diabetes Association (ADA) 66th Annual Scientific Sessions in June of 2006, Merck's Januvia significantly reduced blood sugar levels when used alone or as an add-on therapy in Type 2 Diabetes. Edward S. Horton, M.D., vice president of the Joslin Diabetes Center in Boston and head of its clinical research division.

Januvia is an investigational once-daily medicine that belongs to a new class of drugs called dipeptidyl peptidase-4 or DPP-4 inhibitors. DPP-4 inhibitors have the ability to supplement the body's own ability to lower blood sugar level when it is elevated. The mechanism of action of DPP-4 inhibitors is distinct from that of any other current treatment for diabetes.

In three monotherapy or standalone studies, Januvia given in a dose of 100 mg once daily showed significant reductions in A1C ranging from 0.60% to 1.05%. All patients enrolled in these studies had mean baseline A1C levels ranging from 7.5% to 8.1%. The American Diabetes Association recommends a baseline A1C level of 7 percent or less. In separate Phase III studies where Januvia was given as as add-on to metformin or pioglitazone, A1C reductions of 0.65% and 0.70% respectively were observed.

The data presented at the conference showed significant glucose-lowering effects across a range of patients with type 2 diabetes, especially in those with more elevated baseline A1C levels. A1C is a measure of a person's average blood glucose over a 2 to 3 month period. Januvia was also found to improve beta cell function in diabetes. Beta cells are found in the pancreas and are responsible for producing insulin.

Januvia also demonstrated greater effect in patients who had a higher baseline level of A1C. These reductions ranged from 1.20% to 1.50%. Merck said that Januvia substantially reduced both fasting plasma glucose (FPG) and postprandial, or post-meal, glucose (PPG) levels. The drug also produced significant improvements in measures of beta cell function, namely HOMA-Beta and the fasting proinsulin/insulin ratio.

Januvia had an overall incidence of side effects comparable to placebo and was generally well tolerated. Some of the commonly observed side-effects were stuffy or runny nose and sore throat; headache; diarrhea; upper respiratory infection; joint pain; and urinary tract infection.