Amylin, Eli Lilly: Byetta shown to reduce blood glucose levels when added to patients using thiazolidinedione

By E. Janene Geiss

Philadelphia, June 12 - Amylin Pharmaceuticals, Inc. and Eli Lilly and Co. announced Saturday detailed findings from a study that showed Byetta (exenatide) injection lowered blood glucose levels for people with type 2 diabetes who had not achieved target blood glucose levels despite the use of a thiazolidinedione with or without metformin.

Patients using Byetta showed improvements in three important measures of blood glucose control: fasting blood glucose, postprandial blood glucose and hemoglobin A1C, which improved by about 0.9% compared to the control group, according to a company news release.

In the study, 62% of study participants using Byetta who completed the full study reached target A1C of 7% or less, officials said. Less than 7% is the target for good glucose control as recommended by American Diabetes Association, officials said.

Byetta treatment also resulted in a reduction in average body weight. Byetta-treated patients lost an average of about three pounds of body weight, while those treated with a placebo lost about half of a pound, officials said.

These findings were presented at the annual scientific sessions of the American Diabetes Association in Washington, D.C.

Byetta was approved in April 2005 as an adjunctive therapy for patients with type 2 diabetes who are not achieving blood sugar control on metformin and/or a sulfonylurea.

In the first quarter of 2006, Amylin and Lilly said they submitted a supplemental New Drug Application to the Food and Drug Administration seeking approval of Byetta as an add-on therapy to treatment with a thiazolidinedione with or without metformin in patients with type 2 diabetes.

Amylin is a San Diego biopharmaceutical company.

Eli Lilly is a Indianapolis pharmaceutical products company.

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