Researchers at the University of Florida are launching a new Phase 2 clinical trial to evaluate a combination therapy for individuals recently diagnosed with type 1 diabetes. This study, titled "Precision Administration of Anti-Thymocyte Globulin (ATG) With or Without Verapamil," aims to preserve the body's ability to produce its own insulin by combining two different types of medication. The first is anti-thymocyte globulin, which is a protein-based drug designed to modify the immune system by targeting T cells. The second is verapamil, a pill commonly used to treat high blood pressure. By using these two treatments together, investigators hope to stop the immune system's attack on the pancreas while simultaneously reducing the stress on the remaining insulin-producing cells.
and here is one on Verapamil:
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The Study
This is a phase 2 randomized controlled trial involving 60 participants aged 6 to 35 who have been diagnosed with type 1 diabetes within the last 100 days. Participants will be randomly assigned to receive either ATG or a placebo infusion. After one year, they will be re-randomized to receive either Verapamil or no additional treatment for a second year.
The primary goals of the study are to measure the difference in C-peptide levels (a marker of insulin production) between the ATG and placebo groups at 12 months, and to compare how these levels change over the first 6 months. Secondary goals include exploring the mechanisms behind how these treatments might work together to preserve beta cell function.
This research is supported by BreakthroughT1D (formerly known as JDRF).
For those interested in more information or participation, the global contact for the trial is:
Jennifer L. Hosford, MPH Phone: 352-294-5760 Email: jennifer.hosford@peds.ufl.edu
The trial is currently recruiting participants at the following locations in the US:
- University of Florida, Gainesville, Florida
- Barbara Davis Center for Diabetes, Aurora, Colorado
- University of Miami, Miami, Florida (Collaborating Institution)
Discussion
Previous research in Anti-Thymocyte Globulin research has already shown a small effect to preserve C-peptide for a year or two. This is why the addition of Verapamil is interesting. In a mice study, the combination led to a reversal of T1D. Both of these treatments have a solid safety record for people.
Verapamil has also shown promise in preserving beta cell function. A 2018 study by Ovalle and colleagues at the University of Alabama found that verapamil helped maintain C-peptide levels in adults with recently diagnosed type 1 diabetes.
More Information
The FDA Clinical Trials Registry: https://clinicaltrials.gov/study/NCT06455319
Cancelled Study: https://clinicaltrials.gov/study/NCT07061574
The University of Florida Diabetes Institute: https://diabetes.ufl.edu/
Wikipedia page for Anti-thymocyte globulin: https://en.wikipedia.org/wiki/Anti-thymocyte_globulin
Wikipedia page for Verapamil: https://en.wikipedia.org/wiki/Verapamil
DiaTribe article on Verapamil: https://diatribe.org/diabetes-medications/verapamil-and-type-1-diabetes
The 2018 Haller study in Diabetes Care: https://pubmed.ncbi.nlm.nih.gov/30012675/
The 2025 Degroote study in Diabetologia: https://doi.org/10.1007/s00125-025-06490-8
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official BreakthroughT1D or JDCA news, views, policies or opinions. I sometimes use generative AI ("chatbots") to generate draft blogs, parts of blogs, or drafter alternate wordings for these blogs. I always review every part of every published blog to ensure that it is saying what I want, in the tone that I want, truthfully, and accurately. My kid has type-1 diabetes and has participated in clinical trials, which might be discussed here. I am obese and right on the border of T2D and therefore may be taking drugs for those conditions. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog!
Joshua - Thank you for the information about the ATG/Verapamil combination study. I've heard of T1Ds who have taken Verapamil off label and alone, to no avail. Two questions - Isn't an immuno-modifier an immunosuppressant, which requires a lifelong therapy and thus not a cure under your criteria? When you talk about the established safety record of ATG, does it not have the "bad" side effects of immunosuppressants?
ReplyDeleteYeah, that was me. Verapamil is definitely a dud but GLP-1 (Ozempic) plus Metformin plus Jardiance gave me an A1C of 5.9 last summer (before I caught a bad cough), and now I'm back in health and getting pretty good control. Going on an insulin pump next week and I intend to double down GLP-1 w/ 2mg generic ozempic, then do some top level fasting regimen plus another round of harmine. I believe a closed loop system is actually beneficial, if not absolutely necessary, to give these drugs a chance to regenerate beta cells, which get stressed too easily and die quickly until they can mature. so you need to have near-perfect blood sugars before you even have a chance to build back enough endogenous insulin/c-peptide levels, drugs or no drugs. I have no plans of ever taking verapamil again, I took it over a dozen years, plus various other drugs mentioned here and elsewhere, and it didn't do much if anything for me. But Jardiance and GLP-1/Ozempic combo is a huge winner. I can't wait to see whether a closed loop pump can take it even further. My endo (who is full onboard with offlabel meds, so long as they have some medical support behind them, which GLP-1 does for type 1s as it is nearing official ON label FDA approval for type 1s, if it isn't already, in Canada as well this year apparently)
ReplyDeleteI was one of the first people taking the spit of the gila monster in my blood stream, Victoza all the way back in 2011, and it's not news to me at all that GLP-1 + Type 1 diabetes is a winner. The cough I mentioned was acid reflux / GERD, not related to Jardiance or GLP-1 so I am back on those.
sorry I cut myself off: my endo mentioned other patients who are on omnipod 5 + dexcom g7 + ozempic that ozempic really makes the closed loop system reach a far higher level of blood sugar control, so I look forward to upping my dose back to 2mg pen again now that the generic ozempic is out and reduces the price (both pre and post drug insurance coverage). It's cheap enough to afford it without private insurance now, at least the 1mg version (169$ CAD / month). I only pay 20% so I can definitely afford 2mg / month. It's got diminishing returns but every little bit helps. I believe 16-8 fasting 4 days a week and once a month 24 hour or even 36 hour fasting will do me a lot of good. As you age your auto-immunity gets weaker (ask anyone with Chrons, the symptoms lesson with age), so I'm curious if this applies to type 1s as well. I don't even know which anti-bodies I have, they don't have the tests for them other than anti-gad65 and znt-8, which I am in "normal" (but not actually zero) range.
ReplyDelete