Merck's Januvia effective in combination studies

By Bill Berkrot

NEW YORK (Reuters) - Merck & Co Inc's fast growing diabetes drug Januvia proved effective in helping patients lower blood sugar in combination with Takeda's Actos, and when used along with insulin therapy, according to data from a pair of clinical trials.

In a 497-patient, 24-week study, treatment with Januvia plus Actos as an initial therapy resulted in a 2.4 percent reduction in A1C level compared with a 1.5 percent reduction for patients taking the Takeda Pharmaceutical Co Ltd drug alone, Merck said.

The difference was considered to be statistically significant.

A1C is a key measure of a person's average blood glucose level over a two- to three-month period. The American Diabetes Association (ADA) guidelines call for A1C levels of 7 percent or less. Type 2 diabetes patients began the trial with A1C levels of 8 percent to 12 percent.

Sixty percent of those who received the combination therapy achieved an A1C of less than 7 percent, compared with 28 percent of patients who only took Actos, known chemically as pioglitazone, according to data presented on Saturday at the annual ADA scientific meeting in New Orleans.

Januvia, known chemically as sitagliptin, belongs to a new class of diabetes medicines called DPP-4 inhibitors. Actos belongs to the older, widely used thiazolidinedione, or TZD, class of drugs for the growing type 2 diabetes epidemic.

"Over time most type 2 diabetes patients require multiple drugs to achieve glycemic control," said John Amatruda, Merck's head of diabetes and obesity and one of the study's authors.

Amatruda said these studies should show doctors "that getting patients to goal with initial combination therapy is easier and more effective than the traditional way of treating patients, which was to start them on one drug and wait until they fail on that and then start them on another drug."

Januvia, a pill taken once a day, has been a bright spot for Merck, with sales up 51 percent to $411 million in the first quarter of 2009.

In another 24-week study of 564 patients on insulin therapy, the addition of Januvia reduced A1C by a modest, but statistically significant, 0.6 percent.

Patients in the study had an average baseline A1C level of 8.7 percent. Of those who received Januvia, 13 percent achieved the ADA A1C goal of 7.0 percent or less compared with 5 percent of patients taking insulin plus a placebo.

There was double the incidence of hypoglycemia, or extremely low blood sugar -- 15.5 percent vs 7.8 percent -- in those taking the Januvia combination. Severe hypoglycemic events was 0.6 percent with Januvia compared with 0.3 percent with placebo.

Merck is awaiting U.S. Food and Drug Administration decisions on whether it can expand the Januvia label to include the combination therapies.

A third study showed Merck's Janumet pill, which combines Januvia and metformin, provided better blood sugar control as an initial therapy than metformin alone.

Metformin is one of the most common drugs doctors prescribe as an initial therapy for new type 2 diabetes patients.

(Reporting by Bill Berkrot; Editing by Andre Grenon)