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Once-Weekly Treatment Controlled Type 2 Diabetes Better, in More Patients (77%), with Fewer Side Effects Than Twice-Daily Treatment

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By Samuel Lunenfeld Research Institute, Toronto • www.ProHealth.com • September 8, 2008


“The new once-weekly treatment is expected to undergo Canadian regulatory review as early as 2009.”

In a study published September 8 by The Lancet,* Toronto researcher Dr. Daniel Drucker, MD, reported that a new once-weekly treatment for type 2 diabetes could replace the more common twice-daily injection.

"Over two million Canadians have diabetes," said Dr. Drucker, clinician-scientist and Senior Investigator at the Samuel Lunenfeld Research Institute of Mount Sinai Hospital. "There is currently no available therapy for type 2 diabetes that patients can receive once a week."

The new treatment, Exenatide, once weekly is the first in a new class of long-acting medications that mimic the action of GLP-1 (glucagon-like peptide), a naturally occurring hormone that is produced in the gut after eating.

The report compared outcomes for patients self-injecting Exenatide once weekly against results from the conventional 14 injections a week, as in the currently available version of the drug known as Exenatide (Byetta).

In an international multicenter 6-month clinical trial involving 300 eligible patients:

• 75 percent of study subjects who received the once-weekly Exenatide got their diabetes under control as defined by reaching target glucose levels.

• Patients treated with Exenatide once weekly also experienced fewer side effects, had no increased risk of hypoglycemia (decrease in blood sugars) and saw reductions in body weight.

Dr. Drucker has studied the gut hormone GLP-1 for over 20 years. Multiple drugs based on GLP-1 action are under active clinical development, and the new once-weekly treatment is expected to undergo Canadian regulatory review as early as 2009.

"Biomedical research reaches patients and improves lives," said Dr. Jim Woodgett, Director of Research at the Samuel Lunenfeld Research Institute. "Dr. Drucker is a world-expert in the development of peptide hormone-based therapies for the treatment of human disease and this is an excellent example of moving discovery through to therapeutic application."

[Note: The FDA recently called for stronger label warnings on the twice-daily Exenatide (Byetta) therapy, reflecting reports of acute pancreatitis in some patients taking the medication.]
___
* Source: "Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: A randomized, open-label, non-inferiority study,” The Lancet, Sep 8 2008. Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L. DURATION-1 Study Group. [E-mail: d.drucker@utoronto.ca ]




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