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Bristol-Myers, AstraZeneca Diabetes Drug Effective In Study June, 2008





A late-stage study of saxagliptin, developed by Bristol-Myers Squibb Co. (BMY) and AstraZeneca (AZN), shows the drug is effective in treating type 2 diabetes with a safety profile similar to placebo.

The companies also proposed the brand name Onglyza for saxagliptin if approved by the Food and Drug Administration after their planned mid-2008 filing.

The data from the 24-week study of the once-daily drug in 401 people was presented at the American Diabetes Association Annual Scientific Sessions in San Francisco on Saturday.

In the study, previously untreated patients with an A1C level, a measurement of blood-glucose levels over an average of two to three months, of 7% to 10% were randomized to received saxagliptin in either a 2.5 mg dose, a 5 mg dose, a 10 mg dose or a placebo.

The primary endpoint of the study was the change from baseline A1C, while secondary endpoints included achieving A1C of less than 7%.

The percentage of individuals who achieved the American Diabetes Association's recommended A1C of less than 7% at Week 24 was 35% with the 2.5 mg saxagliptin group, 38% with 5 mg, 41% with 10 mg and 24% with placebo.

Saxagliptin belongs to a type of drugs known as DPP-4 inhibitors. The first such drug was launched in 2006 by Merck & Co. (MRK), of Whitehouse Station, N.J., under the brand name Januvia with 2007 worldwide sales of $668 million.

These drugs are designed to boost the body's ability to lower elevated blood sugar.

Type 2 diabetes, the most common form, occurs when a patient doesn't make enough insulin, which converts sugar, starches and other food into energy and their cells don't seem to take in blood glucose, or sugar, as eagerly as they should.

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