An Interview with Diamyd’s Elna Narula about New Therapies for Type 1 Diabetics

May 23, 2024
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Kelsey Dunn
Saint Joseph’s University
Kelsey Dunn was diagnosed with Type 1 Diabetes when she was 2 years old back in 2005. She is determined to never let her diagnosis define her or limit her to what she can or cannot do. Kelsey is the President of the Saint Joseph’s University chapter of the Diabetes Link. She is studying Health Sciences with a minor in Health Care Ethics and hopes to become a Diabetes Educator and an advocate for those who feel their voice is not heard in the medical field. She enjoys spending time with her family, painting, and thrifting in her free time.

As a college student with diabetes and aspiring Diabetes Educator, I love learning about up-and-coming therapies for people with diabetes. Type 1 Diabetes runs in my family, so I have had a strong support system throughout my life and now I want to be able to give a voice to those who feel like they have none. I believe that just because you have T1D, it does not mean you have to let it define you. I got to interview Elna Narula, US Site Relations and Patient Recruitment Lead at Diamyd Medical, a small Swedish biopharm company that has been involved in type 1 diabetes research for over 30 yrs.

Why/How did you decide to work in the Type 1 Diabetes research field?
My background is in nursing, I was an OBGYN nurse and then my specialty evolved into diabetes in pregnancy. My daughter was diagnosed with Type 1 Diabetes 23 years ago. After her diagnosis, I became interested in research and became a CDE (certified diabetes educator). I was told that to try and preserve her beta cells, we needed to make sure her blood sugar never went too high so I thought “OK, how do I do that, and what do I do? I spent months looking in the US and around the world to see what could be done to save her beta cells to preserve the insulin she still had while in her honeymoon phase.
I found a particular study for those who had been recently diagnosed that was being conducted in Houston, Texas and was able to then get a clinical site at NIH near us started so she could enroll in the study. It was fascinating and I learned so much. I have so much respect for the researchers working in this field.

Many people are wary of being in clinical trials because they do not want to be a “guinea pig in an experiment”. Can you discuss the safety standards required of those doing studies and what makes a Phase I or Phase II clinical trial different than a Phase III clinical trial?
Clinical trials are highly regulated (by large agencies such as the FDA in the US and the European Medicines Agency (EMA) in Europe.) A lot of time is spent on informed consent so that the participants are aware of all the risks and the benefits. There are many pairs of eyes overlooking studies and regulations in place to ensure the safety of the participants. For the Diagnode-3 trial we are currently doing, we have strong safety data because 1000 patients have received our active Diamyd GAD treatment in previous trials over the past 20 years and it has been proven to be safe.
Phase I is where you have a product you want to test and the first thing you have to test for is safety so there are fewer people involved. In Phase II, you are testing to see if the treatment really works, still evaluating safety, and looking more at the best dosage to give, generally with 100 or so people. Then finally, in Phase III you are validating what you found in your Phase II trial and have many more patients, 300 or so in some, and thousands in others.

What would you say the benefits of participating in this clinical trial are? Any clinical trial?
The first general benefit of being in a clinical trial is there is the altruistic benefit of helping out a particular disease or conditions, in our case, the type 1 diabetic community through participating in research to have better treatments, and ultimately a cure. I feel like those participants should know that they are medical heroes through their participation in this research. Hopefully, we can prevent this disease and who knows, we may even be able to give boosters at some point to keep it at bay.
What I really liked when my daughter participated in research studies, was that there was another set of eyes monitoring her and she was learning more and more about research going on in type 1. Being in studies helps you understand your disease a lot more. It’s the extra diabetes education and understanding you get along with the possibility of living a better life with type 1 or whatever condition you have. In most studies, you have 50% receiving placebo (the inactive substance) and 50% getting the actual drug; however, in our present Diagnode-3 study, only ⅓ of participants will receive the placebo and 2/3rd get the Diamyd GAD, and it has a good safety profile so that’s a particular benefit here. Another benefit to this study, or trial, is that our drug does not suppress the immune system; it is not an immunosuppressant. Instead it directly targets the substance that is causing the attack on the beta cells, and down regulates/ tones down the effect, slowing down or halting that autoimmune attack. So it’s called an immunomodulator.

Can you tell us about the Phase III clinical trial presently enrolling those recently diagnosed with T1D in the US?
Our study Diagnode-3 is looking for those within the first 6 months of diagnosis, from the age of 12 up to 29 years old. We have 13 sites across the US and these are listed on our website (https://diagnode-3.com/). We need to make sure that people know about this study so they have the opportunity to participate. Even if you are far from a specific study site, we will reimburse for travel costs. Once you arrive at a site you will be screened to see if you carry a specific gene (the HLA DR3/DQ2 one that about half of all type 1’s carry) and if you qualify, you will have 3 injections over 3 months, and then there’s a follow-up period of 22 months. No hospitalization is required.

Why is it called the first “precision medicine trial in T1D” and what makes it so unique?
In the 20 plus years of studying Diamyd’s GAD product, (It’s based on the human GAD65 protein in the body), Diamyd researchers figured out from all of the clinical trials that there is a certain genetic subgroup of those with autoimmune diabetes who are the ones who respond well to this treatment. This group of about 40 % of type 1’s make autoantibodies against GAD65 that destroy the insulin-producing beta cells. Our GAD drug product is being tested for its’ ability to stop this attack. It is a precision medicine treatment since it is being used to treat only those who respond to this treatment and who carry that specific HLA gene. The same way we are now able to treat certain kinds of cancer with gene therapy. It’s exciting that we are at the forefront of this in diabetes.

What has been the greatest challenge in this project thus far?
Well, we have had some setbacks in getting our sites up and running that happens in many clinical trials. It takes a lot of time, patience, hard work, and resources – people ones and financial ones to run big studies. The current challenge for us is that we have to find twice as many participants to screen to find the half who do carry this HLA genotype among those newly diagnosed, and there are other trials competing for those who are newly diagnosed too. We need to get the word out in the US. The main reason there are not more people in clinical trials of all kinds is simply that people don’t know about them.

What advice do you have for teens/young adults interested in diabetes research?
Honestly, the best thing, if somebody has an inclination towards that – go intern! (NIH or anywhere) Just spend a day and see if that’s something you would like to do. We need more endocrinologists and more people in research! ‘The Sugar Science ‘is a great resource: https://thesugarscience.org. See all of the interviews about Type 1 research, it is really neat! Keep looking for mentors, people, anyone willing to assist you.

How can The Diabetes Link community help spread the word about this so teens/young adults know this is an option for them? Where can people go online to find out more about this study?
It would be helpful if different chapters can spread the word that our study is out there. On college campuses, if they come across those newly diagnosed, please tell them about this option. In fact, all type 1’s can check out JDRF’s website as well as Children with Diabetes weekly newsletter to find out what clinical trials are happening in their area. Also, discuss and inform your own endos and diabetes educators about what you find and are interested in.

Anyone can access more information on our website, www.diagnode-3.com which lists all of our US clinics and contact information. We need and appreciate your wonderful community helping to get the word out. Thank you!

About the Diagnode-3 Trial:

The ultimate goal of the Diagnode-3 trial is to determine if the investigational medicine Diamyd® can postpone the body’s attack on its immune system’s insulin-producing beta cells in the pancreas. Improved blood sugar regulation and a lower incidence of hypoglycemia, ketoacidosis, and problems in later life are linked to sustained beta cell function. This trial is open to patients who were recently diagnosed (within 6 months) because this drug (Diamyd®) aims to delay the attack on the beta cells so, this drug is believed to be most effective early in the disease (Type 1 Diabetes) where it is still possible to save some insulin-producing cells. Learn more about the trial at wwww.diagnode-3.com.

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