Since its introduction in 2005, Byetta has become “the talk of the town” as one of the most powerful, yet benign, diabetes drugs of the 21st century.

Most people with diabetes or who are close to the diabetes community have heard the many anecdotal tales about the drug’s dramatic effects on type 2s: substantial weight loss; excellent appetite control; often drastically lowered A1c’s and BGs.

(One of the more powerful testimonies to Byetta we’ve seen is the article we excerpted from David Mendosa’s book, “Losing Weight With Your Diabetes Medication,” in our Dec. 2007/Jan. 2008 issue. The article is also online: go to www.diabeteshealth.com and enter 5557 in the search feature.)

Ready to Stand Alone?

Until now Byetta has always been used in conjunction with other diabetes medications, such as metformin and TZDs. But as evidence of Byetta’s potency builds, people have wondered if the drug might ever be used as a monotherapy – a standalone treatment that need not be used in conjunction with any other drug.

There have been some indications that the drug’s manufacturer, Amylin Pharmaceuticals and its partner, Eli Lilly, were going to push for Byetta’s status as a monotherapy. One of them came at the AADE convention in St, Louis in 2007 when Scott King, Diabetes Health’s editor-in-chief, spoke with Amylin’s Craig Eberhard about that possibility.

Eberhard didn’t quite come out and advocate for Byetta as a monotherapy, but he strongly hinted that Amylin would soon push for exactly that status. (To see the interview, go to www.diabeteshealth.com and click on “Watch Our Latest TV Show!” Scroll down to “Could Byetta Become a Standalone Drug?)

Amylin, Lilly Ready to Pop the Question

Now, buoyed by the positive results of a 24-week study, Amylin and Lilly will petition the U.S. Food and Drug Administration by July to determine whether doctors can begin offering the drug as a standalone treatment for type 2.

In the study, 232 “drug naïve”* type 2 patients took 5mcg or 10mcg of Byetta twice daily, unaccompanied by any other diabetes drug. Patients taking the smaller dose saw their A1c’s drop by 0.7 percentage points, while those taking the larger dosage saw theirs drop by 0.9 percentage points. The baseline A1c’s for both groups at the start of the study ranged from 7.8 to 7.9 percent.

About 60 percent of the study’s participants were able to achieve A1c’s of 7 percent or less."These data are robust and are consistent with data from other trials that support the use of Byetta before starter insulin,” says James Malone, M.D., Global Medical Director, Eli Lilly and Company.. If approved for monotherapy, Byetta may provide an additional treatment option for physicians to consider earlier in the continuum of care."

* “Drug naïve” means patients who have not previously taken the drug or drugs in a clinical study.