Merck: Januvia as monotherapy reduces blood sugar levels in phase 3 studies

By Lisa Kerner

Charlotte, N.C., June 12 - Merck and Co., Inc. said newly released phase 3 studies demonstrated that Januvia (sitagliptin phosphate), its investigational oral, once-daily DPP-4 inhibitor for type 2 diabetes, significantly reduced blood sugar (glucose) levels when used as monotherapy or as an add-on treatment to metformin or pioglitazone.

Januvia was also shown to improve the function of beta cells that make and release insulin in the pancreas, according to a company news release.

Merck presented the study results at the American Diabetes Association 66th Annual Scientific Sessions in Washington, D.C.

"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," the vice president of the Joslin Diabetes Center in Boston, Edward S. Horton, said in the release.

"In these studies, a low rate of hypoglycemia was observed and Januvia was generally weight neutral."

Januvia had an overall incidence of side effects comparable to a placebo and was generally well-tolerated in the phase 2 studies, the company said.

In two phase 3 add-on studies, 47% of patients achieved A1C of less than 7% with the addition of Januvia compared to 18% for a placebo, 45% for metformin and 23% for pioglitazone.

Merck is a research-driven pharmaceutical company based in Whitehouse Station, N.J.

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