ADA:BYETTA(R) Extension Study Results Shows Sustained Improvements in Blood Gluc

ADA:BYETTA(R) Extension Study Results Shows Sustained Improvements in Blood Glucose Control and Progressive Weight Loss After Two Years
Patients sustained an average hemoglobin A1C (A1C) reduction of 1.1 percent from baseline and Average weight loss improved to 10 pounds from the average of five pounds seen after 30 weeks. Fasting blood glucose was reduced 25 mg/dL. Results announced for two-year study results showing that BYETTA(R) (exenatide) injection sustained improvements in blood sugar control and reduced body weight in people with type 2 diabetes who previously did not achieve adequate control of their blood sugar on common oral medications.

After two years of treatment, patients sustained an average hemoglobin A1C (A1C) reduction of 1.1 percent from baseline. This A1C reduction compares to an A1C reduction of 1.1 percent at the end of the initial 30-week clinical trial, demonstrating sustained efficacy over the two-year period. The ADA recommends a target A1C of less than 7 percent; fifty percent of patients in this study reached an A1C of 7 percent or less, and 31 percent achieved an A1C of 6.5 percent or less after two years of treatment.

Average weight loss improved to 10 pounds from the average of five pounds seen after 30 weeks. Fasting blood glucose was reduced 25 mg/dL. Additionally, HOMA-B, a clinical measurement of beta-cell function, was assessed in a subset of study participants. Participants treated with BYETTA showed significant improvement in HOMA-B from study start to end after two years.

There were 283 patients from the original 30-week exenatide pivotal trials that completed 2 years of BYETTA treatment in open-label extension trials. All patients in this "completer cohort" received BYETTA twice daily in addition to their current diabetes treatment. Data collected and assessed over two years demonstrated that long-term administration of BYETTA in combination with metformin, a sulfonylurea or both, resulted in sustained reductions in blood sugar and progressive reductions in weight.

Data Presented at the ADA 66th Scientific Session, June 2006

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