What if a once-a-week injection could stave off long-term diabetes complications like nerve, kidney and eye damage? And what if that shot, not too different than giving yourself a dose of insulin, was something you could have done in a routine doctor's visit at the same time they're measuring blood pressure, cholesterol, and other in-office blood checks?
Wouldn't you jump at the chance?
A small San Diego, CA-based biopharmaceutical company called Cebix wants people with diabetes (PWDs) to think that way about nerve damage, whether it's something you feel is impacting your life or not. Their thought: Diabetic Peripheral Neuropathy (DPN) is sneaky and can come at PWDs without warning, so why not make proactive prevention a part of the routine checks at the doc's office?
This could be coming down the pipeline, if early clinical trials of a new drug called ERSATTA being developed by Cebix pans out the way they're hoping.
It all relies on the C-peptide hormone, which in non-pancreatically challenged people is produced in conjunction with insulin. But for those of us living with type 1, it's not made for whatever reason. And it's removed from our manufactured human insulins. Researchers have been analyzing the mystery of C-peptide for a long time, and clinical trials of native C-peptide have demonstrated the hormone has beneficial effects relating to diabetes complications like neuropathy, nephropathy and retinopathy.
So, now the push is to create a commercial drug that could mimic those effects longer than the 1-1/2-hour shelf life of natural C-peptide. And Cebix isn't the only organization convinced that C-peptide has huge healing potential. The national advocacy organization Diabetes UK is actually running a big campaign to support C-peptide research right now. Watch this:
The data is stacking up about just how important a C-peptide drug like what Cebix is working on could be for us PWDs.
Cebix is now recruiting PWDs for its second-phase study. They have just over 100 patients enrolled at this point, and by year's end hope to have 240 diabetics signed on for further trial-testing. Aside from typical neuropathy, the upcoming research will also look at the drug's effects on vibration sensation, neurological status, erectile dysfunction and overall quality of life (the latter two being closely related?)
Those participating in the trial to date have shared with trial coordinators that they didn't see the true benefit of ERSATTA until they stopped taking it as part of the trial. Some have shared anecdotes about having their dry, cracked skin clearing up, and that their typically cold feet and hands felt warmer -- stories supported by the research that shows more nutrients appear to be getting to those extremities because of increased circulation.
The company says the FDA has fast-tracked this drug, as there's a pressing unmet need out there in the diabetes community. Stats from the American Diabetes Association (ADA) tell us about half of PWDs have some form of neuropathy. And as we know from our own past 411 series on complications, the nerve damage happens when excessive blood glucose injures the walls of tiny blood vessels that nourish the nerves.
I've personally been living with neuropathy for about a decade. At times, I've experienced shooting pains in my feet and have had some numbness in the feet and lower legs. But in taking neurontin pills at those worst times, the symptoms faded and better blood sugar management over time helped reign in that complication so it wasn't impacting my life. So, that's something I wonder about with this new injection drug -- how reluctant will I, and other PWDs, be to taking another injection if we're not feeling any symptoms and aren't really bothered by neuropathy? Nobody likes injections, after all.
Cebix president and CEO Joel Martin told us that's one of the biggest challenges the company is facing.
"A lot of people who have mild complications aren't particularly motivated to get involved in clinical studies about their complications," he said. "But we liken this to both cholesterol and blood pressure... in the early days, people didn't do anything about those until they had a heart attack. Now, they're routine checks at the doctor."
Although the eight-person company doesn't have any personal D-Connection, Martin emphasized that Cebix is working closely with some prominent names in the community -- including Dr. Steve Edelman of TCOYD (Taking Control Of Your Diabetes).
Martin says they're trying to spread the word about this clinical study, because it has unique potential to help the PWD population long-term.
"This is a progressive problem and we have the ability to determine if there's a way to prevent and even reverse those long-term complications," Martin said. "Really, this might spare a lot of trouble down the road. We think this could be a part of the whole preventative-health package to help keep diabetics healthy, just like making sure your A1C levels are kept down, exercising and eating right."