Exenatide Efficacious, Delivers Weight-Reduction Benefit in Type 2 Diabetes


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Bonnie Darves

June 16, 2005 (San Diego) — Patients with type 2 diabetes who take the new
incretin mimetic drug exenatide (Byetta) appear to achieve sustained glucose
control and progressive weight reduction after 18 months of therapy, according
to results of a new study presented here at the American Diabetes Association's
65th Annual Scientific Sessions.

In the study of patients who had failed to achieve adequate control with
standard therapy, the switch to injectible exenatide also appeared to improve
lipid profiles and reduce blood pressure.

"These findings — the first long-term data we have had on this drug —
demonstrate that it may be especially beneficial for patients who have been
unsuccessful in achieving effective management," said study coinvestigator David
Kendall, MD, chief of clinical services and medical director of the
International Diabetes Center in Minneapolis, Minnesota. "We did not see any new
safety issues with longer term use — the GI [gastrointestinal] effects were
consistent with what we saw in the earlier trials."

At baseline, participants' mean age was 56 years, mean body mass index was 34
kg/m2, and the times since diagnosis of type 2 diabetes was seven years.
Patients who received the 10-µg dose in combination with metformin and/or a
sulfonylurea, attained an A1C reduction of 1.2% from baseline and lost an
average of 12.1 lb for the study period. A total of 83% of participants lost
weight for the duration of the study period.

Exenatide, the first drug in this new class approved by the U.S. Food and Drug
Administration, has been on the market less than two months. The incretin
mimetics work by mimicking the glucose-lowering actions performed by human
incretin hormones. In diabetes, the drug works to stimulate insulin production
and inhibit postprandial release of glucagon.

The study involved 146 patients who remained in an extension of a trial that
originally included 285 patients and who completed 82 weeks of treatment. The
most common adverse effect was nausea, which affected less than 10% of patients
in the extension study, and appeared to decrease over time in most affected
patients, Dr. Kendall noted. He also cautioned that patients who take
sulfonylureas in conjunction with exenatide may experience periodic
hypoglycemia, possibly necessitating a reduction in the sulfonylurea dose. In
addition, the drug is contraindicated for individuals with severe renal disease.

Joseph Prendergast, MD, an endocrinologist in Redwood City, California, who
recently began treating patients with exenatide, thinks that the drug itself and
the development of incretins, represent a milestone in endocrinology. "This is a
major development and it is potentially advantageous for those patients who have
not been successful with standard approaches," Dr. Prendergast said. "This
really is the most exciting time in the history of the field [endocrinology],
and the concept of multiple-target [drugs] also appears intriguing and
promising."

Reviewed by Gary D. Vogin, MD

Bonnie Darves is a freelance writer for Medscape.
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65th Scientific Sessions of the American Diabetes Association






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