Perle Bioscience Soon to Be Ready for Phase III Cinical Trial

Perle Bioscience and its team of amazing clinicians and researchers is getting ready for Phase III in its clinical trials. They will need newly diagnosed Type 1s for this trial. Specific information on the trials and eligibility is at

The study is for a combination therapy that uses an immune agent to protect beta cells and regeneration therapy of insulin producing beta cells/ It isn't a cure but it could liberate Type 1s from the need for insulin by starting up production and it could help T2s by increasing the level insulin they produce.

If you are recently diagnosed with T1 (including LADAs) or hear of someone who is -- this study may be worth considering. Regardless, the Perle Bioscience website has some great info about the science so it is definitely a great read.

This post is approved by the TuDiabetes Admin Team.

I do think this is encouraging and can be so helpful to newly diagnosed Type 1 patients. My concern and frustration is that every single study I have come across regarding research to treat and preserve beta cells are for people under the age of 45! I find it quite disturbing that there seems to be nothing available for older patients;especially since what I learned on this forum and from reading research is that type 1 can occur at any age. I don't know if there is a specific reason for the age cutoff, because I would hope that the medical profession cares about treating us; although the focus seems to be on treatment of disease rather than prevention.
I'm sorry for the rant, but I've been spending some time searching and coming up with nothing and it's a bit discouraging.

I can actually explain the age cut off in this case. As with all clinical trials, experts in FDA regulation help set up the trial. There is a concern that if people over a certain age were used, that the study would be criticized by those who want to say that LADA is different than Type 1. It is about getting results impervious to criticism so that the trial can move to the step of FDA approval if successful. The good news is, if proven to work, this therapy will be for everyone regardless of age.

But I definitely hear what you're saying. I was diagnosed over age 40 with Type 1 (after being misdiagnosed of course -- the other common thing that happens to us older onset patients). But until the diabetes world universally accepts latent onset or rapid adult onset Type 1 as the same disease, clinical trials are going to have a cut off. It's all so naysayers cannot try to knock down the legitimacy of the results on the basis of the age of the participants.

Thanks, Donna, for posting this. I do hope that some new-onset Type 1s will look into it. If I were diagnosed today (not close to 20 years ago as is the case, in 1995) I would hunt down the best clinical trial to preserve beta cell function/insulin production, such as this trial, and do it.

We can be grateful for the amazing progress that is being made today.

Thanks for the explanation. It does explain it somewhat; although it's still discouraging. Like Melitta said below I've been trying to find a clinical trial since my diagnosis is so early. I almost feel like the NIH research study I am in now is just to collect data on how long it takes for a LADA patient to go on insulin.

I also have been frustrated with the limits on many studies, including age, a1c etc. I just wonder if this will really be available to everyone though if it helps and it is approved. Most of us have had diabetes for more than 3 months. That is a pretty sharp cut off. I kept asking my endo about studies after I was diagnosed and he said my a1c was too good and then started saying I had had diabetes for too long. With some of these studies it seems like a losing situation for those of us who might want to participate.

The plan is for it to be available to all T1s and we believe it could be a solution for T2s too Of course that all depends on what the FDA approves in the end. The study is geared to new diabetes because of what needs to prove with regard to the destruction and regeneration of beta cells. To prove the therapy out to the regulators, they need some beta cells to start. The parameters are set by the regulatory experts so that the trial proves out with the right controls. Initially I had hoped to participate in this study. But I am way outside of the parameters. Yet, I can take that disappointment if the end result is no need to inject or pump insulin ever again. And that's the hope with this. It would be great if someone would finally prove that T1 is T1 -- even when you get it as an adult. Unfortunately, there is no incentive for a drug company to explore that. This would have to be an academic pursuit.

You're right Donna, if this pans out and can help us to that extent it would be great and I would be very thankful of course. I just wish I could have participated in something like this early on too. I'm thinking about signing up for the encapsulation when it comes to my area.