Monday, June 9, 2008

By Bill Berkrot

NEW YORK (Reuters) - An experimental drug being developed by Bristol-Myers Squibb Co and AstraZeneca Plc was significantly more effective than a placebo in patients who had not previously been treated for their type 2 diabetes, according to data presented on Saturday.

The once-daily oral drug, saxagliptin, met the primary goal at all three tested doses of reduction from baseline in A1C levels - a measure of blood sugar - compared with a placebo after 24 weeks in a late stage study of 401 patients.

In addition, the two higher doses - 5 milligrams and 10 mg - were statistically significantly better than placebo at helping patients reach recommended A1C levels of less than 7 percent, according to data presented at the American Diabetes Association (ADA) scientific meeting in San Francisco.

If approved, saxagliptin would compete with Merck and Co Inc's successful Januvia drug, which belongs to the same new class of diabetes medicines called DPP-4 inhibitors.

Saxagliptin in the study had a similar adverse side effect profile to placebo and did not cause weight gain as seen with some older treatments. Effect on weight can be critical in diabetes treatments because obesity is one of the leading causes of the disease.

The patients in the study were between the ages of 18 and 77 and had A1C levels of between 7 and 10 percent.

Reductions in A1C levels were seen as early as 4 weeks after initiating treatment, researchers said.

At 24 weeks, saxagliptin patients had placebo-adjusted A1C level reductions of 0.6 percent, 0.6 percent and 0.7 percent at 2.5 mg, 5 mg and 10 mg, respectively, all deemed to be highly statistically significant and similar to results seen with Januvia.

Forty-one percent of patients taking 10 mg of saxagliptin reached the ADA recommended target of 7 percent A1C level, as did 38 percent at 5 mg and 35 percent at 2.5 mg, compared with 24 percent in the placebo group. Only the result from the 2.5 mg group did not reach statistical significance.

Saxagliptin also produced significant reductions in other blood sugar measures that were secondary goals of the trial - fasting plasma glucose and postprandial glucose, the companies said.

"We're pretty excited about this study. Specifically, saxagliptin here as monotherapy in this treatment naive patient population led to clinically meaningful results in all key glycemic control parameters," said Dr. Roland Chen, group director at Bristol-Myers Squibb global clinical research, who presented the study at the meeting.

The drug has also been tested as add-on therapy in patients unable to reach target blood glucose levels on their regular medication.

DPP-4 inhibitors work by increasing the body's utilization of sugar, primarily through increasing insulin production in the pancreas and by reducing the liver's glucose production.