If you’ve been diagnosed with type 1 diabetes (T1D) within the last six months — and you’re between the ages of 12 and 29 years old — you should know about Diamyd Medical’s clinical trial. Diamyd’s groundbreaking therapy could help protect your body’s natural insulin production.
Here’s what you need to know.
What is Diamyd?
Diamyd was founded in Sweden in the 1990s by Anders Essen-Moller after his daughter was diagnosed with T1D at 10 years old. Essen-Moller, an executive for a medical business, immediately began traveling the world to investigate ongoing T1D cure research.
He homed in on the enzyme glutamic acid decarboxylase, or GAD, a focus in research at the University of California, Los Angeles at the time. GAD is a naturally occurring enzyme produced by the cells in your pancreas that also produce insulin. When your immune system attacks those cells, it attacks GAD, too. Essen-Moller licensed GAD development from UCLA and still has exclusive rights to developing GAD treatments today.
Essen-Moller founded Diamyd, with the “Dia” coming from the word diabetes, “My” from his daughter’s name, and “D” from the last letter in GAD.
What is GAD-65?
Over the thirty years, Diamyd has been developing the therapy GAD-65. They’ve already completed Phase 1 and Phase 2 of the clinical trial process.
GAD-65 was developed to protect the cells in the pancreas from autoimmune attacks. By shielding the cells that produce GAD, it also preserves insulin production.
In a nutshell, GAD-65 simply tells your immune system to stop attacking and destroying the cells in your pancreas that produce insulin. GAD-65 basically says, “Hey! This enzyme is not foreign. It’s not bad. It belongs in the body. Stop attacking it!”
GAD-65 is considered an “immune-modulator” because it does not suppress your immune system. Instead, reprograms your immune system. It’s teaching your immune system to behave differently — which is good when the immune system is doing ridiculous things like attacking and destroying the cells that produce insulin.
Diamyd’s phase 2 clinical trial helped determine that the treatment has a good safety profile and that it had encouraging effects on insulin preservation. Now, onto Phase 3: a larger and longer trial determining GAD-65’s efficacy compared to traditional treatments, like daily insulin injections.
If you’ve been recently diagnosed with T1D, your body still produces a reasonable amount of insulin-producing cells, so there’s still time to intervene and protect those remaining cells. The longer you’ve lived with T1D, the fewer insulin-producing cells your body still makes — if any.
Diamyd states that GAD-65 is the first “precision medicine” treatment in development for type 1 diabetes.
GAD-65 is Precision Medicine
Precision medicine is a relatively new term in medicine. It describes any therapy targeting a specific subgroup of people beyond their diagnosis. For example, in cancer treatments, precision medicine identifies specific treatment plans for specific types of cancer based on the patient’s genetic makeup. Precision medicine is defined as developing treatments based on the specific details of a patient’s genetics and deeper details of the disease.
In Diamyd’s earlier trials, GAD-65 was only effective in about 40 percent of participants. This is when Diamyd’s researchers discovered that the treatment’s effect was linked to the presence of a very specific gene — a gene that is found in about 40 to 50 percent of people with T1D!
The HLA DR3-DQ2 haplotype gene plays a critical role in Diamyd’s therapy. In fact, the first step in their clinical trial is getting tested for this gene.
How to Participate in Diamyd’s Trial
Diamyd needs regular people to volunteer for GAD-65’s stage 3 clinical trial. If you qualify, participating is relatively straightforward:
You might qualify if:
You were diagnosed with type 1 diabetes within the last six months.
You’re between the ages of 12 and 29 years old.
You live in/near one of the United States or European clinic sites: study locations. (Diamyd will cover your travel expenses.)
How the study works:
First, you’re screened for basic qualifying criteria.
Then you’ll be screened for the HLA DR3-DQ2 haplotype gene.
Next, you’ll receive three injections of GAD-65 or the placebo over 2 months.
You’ll go about your everyday life while receiving those injections.
67 percent of participants will receive GAD-65, with only 33 percent receiving a placebo.
GAD-65 is administered with injections in a lymph node in your groin over the course of several months. The injections feel similar to getting your blood drawn at a lab. If you can handle an intravenous blood draw, you can handle injections of GAD-65.
The follow-up period after the injections lasts for 22 months.
Throughout that 22-month follow-up period, you’ll have recurring bloodwork done to evaluate insulin production, blood glucose levels, etc.
Diamyd is just one of many companies developing life-changing therapies for people with T1D. It’s exciting!
Learn more about Diamyd’s trial at Diagnode-3 or email ClinicalTrails@Diamyd.com.