Sept. 8, 2008 -- A time-released version of the popular type 2 diabetes drug Byetta proved more effective for controlling blood sugar in a newly released study than the currently approved version of the drug. The new version requires just one injection a week instead of two shots a day.
If future trials prove as promising, experts say the once-a-week treatment could usher in a new era of diabetes treatment.
Since its approval by the FDA in 2005, the twice-daily form of Byetta has quickly become one of the most widely prescribed diabetes treatments in the U.S.
Sales of the drug rose to $177 million nationwide in the second quarter of this year, according to figures from manufacturers Eli Lilly & Company and Amylin Pharmaceuticals.
But concerns about a rare but potentially deadly pancreatic condition potentially linked to its use led federal regulators to announce plans to strengthen warnings about the drug last month.
The new, time-released formulation of the drug has not been submitted to the FDA for review, but a spokesman for Lilly tells WebMD that this should happen by next summer.
"Type 2 diabetes is a tough disease to treat and the numbers are growing," says Lilly medical fellow John Holcombe, MD. "While this [once-weekly] drug is not yet approved and there is no guarantee that it will be, the results from the clinical trials are very encouraging."
In its currently available form, Byetta is most often used to treat patients who no longer respond adequately to oral diabetes drugs alone.
Unlike insulin and some other diabetes treatments, which can lead to weight gain, patients who take Byetta often experience significant weight loss.
But gastrointestinal side effects, including nausea and vomiting, are also common with the drug.
In the newly reported study, funded by Lilly and Amylin, 259 patients with type 2 diabetes were treated with either the once-weekly, long-acting form of the drug or the twice-daily version for 30 weeks.
Most of the patients in both arms of the study saw significant improvements in glucose control with treatment. But the patients who got the once-weekly Byetta injections showed greater improvement in a widely used glucose control measure known as hemoglobin A1c.
Average hemoglobin A1c levels for all patients at study entry was 8.3%. Levels fell to an average of 6.4% among patients treated with the once-weekly formulation of the drug and 6.8% in patients treated with the twice-a-day formulation. The hemoglobin A1c goal for people with diabetes is less than 7%.
Similar reductions in weight were seen among the two treatment groups. Nine patients in the once-a-week arm of the study and eight patients in the twice-daily arm withdrew due to side effects, but, overall, the patients who got once-weekly injections had less nausea and vomiting.
The study appears in the latest online issue of The Lancet, published today.
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