July 20, 2009 / 9:45 PM / 11 years ago

CORRECTED - UPDATE 1-Amylin's long-acting Byetta prevails anew in trial

(Corrects that Byetta medicine is injectable, not pill, paragraph 2)

*Byetta once weekly beats Lantus in cutting blood sugar

*Byetta 1/wk users lose 5.8 lbs, Lantus users gain 3.1 lbs

*Hypoglycemia incidents far lower in the Byetta users

By Ransdell Pierson

NEW YORK, July 20 (Reuters) - A long-acting diabetes drug being developed by Amylin Pharmaceuticals Inc AMLN.O and Eli Lilly and Co (LLY.N) proved more effective than Sanofi-Aventis’ (SASY.PA) widely used Lantus insulin medicine in a clinical study, Amylin and Lilly said on Monday.

The success of the experimental medicine, a once-weekly form of their Byetta drug now awaiting U.S. approval, follows successful trials of the long-acting injectable medicine against other leading diabetes treatments.

In the new study, once-weekly Byetta (exenatide) was tested against Lantus for 26 weeks among 467 patients with type 2 diabetes, the most common form of diabetes. All patients had previously failed to adequately control their blood sugar with metformin alone or in combination with another class of oral drugs called sulfonylureas.

The study measured reduction of A1C, a measure of average blood sugar over a period of three months.

“At the end of the study, patients treated with exenatide (Byetta) once weekly achieved a mean A1C of 6.8 percent compared with a mean A1C of 7.0 percent in those treated with Lantus,” a statistically significant improvement, the drugmakers said in a joint release.

American Diabetes Association guidelines call for A1C level of 7 percent or less.

Moreover, patients taking Byetta once weekly lost on average 5.8 pounds (2.6 kg) after six months, compared with a weight gain of 3.1 pounds (1.4 kg) for Lantus — a particularly desirable benefit as obesity is one of the leading causes of type 2 diabetes.

Byetta patients also had a significantly lower incidence of hypoglycemia, a potentially dangerous over-reduction in blood sugar, compared with those taking Lantus.

Lilly and Amylin said they plan to present full data from the trial at a major medical meeting and submit the data for publication.

The drugmakers in late March said Byetta once weekly provided superior blood control to Merck & Co’s (MRK.N) Januvia and another widely used pill called Actos sold by Japan’s Takeda Pharmaceutical Co Ltd (4502.T) (Reporting by Ransdell Pierson; Additional reporting by Bill Berkrot; Editing by Gary Hill)

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