A Once-Weekly Diabetes Treatment that Aids with Weight Loss?

February 10, 2009

Amy Tenderich of DiabetesMine.com

Amylin Pharmaceuticals is working on something they’re hailing as a potential miracle drug: the first-ever once-weekly diabetes treatment that’s guaranteed to bring down your blood sugar levels and help you lose weight and keep it off. It certainly sounds amazing, no?

The drug is a new “extended” version of exenatide (commercial name: Byetta, an injectable used to treat Type 2 diabetes) that will be submitted for FDA approval by the end of 2009. It belongs to a class of drugs called GLP-1s, gut hormones that lower glucose levels by increasing insulin secretion from the pancreas and suppressing the release of glucagon (glucose in the bloodstream). It also curbs your appetite by slowing gastric emptying.

In studies, patients testing the new long-acting drug achieved an AVERAGE of a two percentage-point drop in their A1C (measure of glucose levels over the last three months), and also lost an average of 9.5 pounds and kept the weight off for at least six months, Amylin reports. That kind of impact is extraordinary, to be sure
The company is positioning this new once-weekly as the “missing link” in diabetes care due to the killer combination of these unprecedented results, and the fact that it will be so easy to use that patients can and will more consistently stick to their treatment regimen.
They say it can also be safely combined with metformin and other oral drugs, and they’ll be studying its efficacy against these drugs and also against insulin itself in the next few years.
At a recent healthcare investor’s conference in San Francisco, where I learned about the drug, Amylin was even quoting prominent physicians as saying this drug – when it’s ready for market – will create an entirely “new class of treatment for Type 2 diabetes.”
Wow! I hope they are right. We hear about potential miracle meds all the time, so it’s wise to take this news with a grain of salt as well. As always, there are some good reasons for optimism and pessimism alike:
A bit about Byetta:
The current version of Byetta is administered in an injection pen with a tiny needle twice daily, usually before the first and last meal of the day. Because of its effectiveness with glucose control and weight loss, Byetta has quickly become one of the most widely prescribed diabetes treatments in the US.
However, its main side effect is nausea and other gastrointestinal discomfort, so it’s not meant for people who already have problems in that area. Also, there was a recent safety scare when several patients using the drug showed up with acute pancreatitis, including several deaths. But the FDA has continued to sanction the drug since no definite causal relationship has been established.

FDA hurdles:
One potential roadblock is tightening FDA regulations for approval of all new diabetes drugs. After the evidence that a controversial drug called Avandia may significantly increase patients’ risk of heart attack, the FDA is cracking down with stringent new research requirements. Some folks are worried that this may slow down approvals of new diabetes drugs “to the pace of molasses.”
Let’s hope they can strike a balance between safety and progress towards innovative new treatments. Because according to experts like diabetes researcher Andre J. Scheen, MD, PhD, of Belgium's University of Liege, the once-weekly version of exenatide will provide better blood sugar control and reduced nausea. “This new strategy might substantially change the management of Type 2 diabetes," he writes.

From	Comment
LadyDi	February 11, 2009 9:48 PM I agree with you, Amy. Not everyone has the Byetta/Gastroparesis problem. If they can get this to work, I think it would be wonderful.
Amy Tenderich	February 11, 2009 9:36 PM Avera, You are right that Byetta currently has GI effects, as mentioned in the article. One of the motivations behind the long-acting version is reducing that side effect, the way I understand it. Sure, let's hope for a cure. In the meantime, let's hope for improved treatments.
Avera	February 11, 2009 3:25 AM There is just one problem with this. Anyone with Gastroparesis will have difficulty taking any drug that keeps the disgestive system from emptying. Byetta causes 89% of people with Gastroparesis to actually have food lump into clumps in their stomach and put in heartburn problems and you really have a problem. Truth is,,,,the drug companies know that right now any med popular with Typw 2 diabetics is money in the bank. They should spend the money better by looking for a cause and a cure for both Type 1 and 2. Anyone want to loan me money to buy some stock?
LadyDi	February 10, 2009 10:40 PM Well, wouldn't that be the best thing since sliced bread?!! This sounds promising and exciting. Let's all pray hard about this one. Anything that allow us better control, more freedom and some hope for the future is something we all can get excited about.