We have another treatment for early Type 1 Diabetes today, one that can delay the full disease for as much as three years, with only two brief courses of treatment. The next question is whether this treatment can protect implanted beta cells derived from the patient’s stem cells, and how long that effect would last. If everything were to work out, this could approach a real cure.
Teplizumab (Tzield®) helps preserve the ability of children and adolescents with new-onset type 1 diabetes to make their own insulin, a phase 3 trial finds. The drug was approved by the U.S. Food and Drug Administration (FDA) in November 2022 after it was shown to delay the onset of stage 3 type 1 diabetes.
Now, the PROTECT study has evaluated whether it could also preserve the function of beta cells—which produce insulin—in recently diagnosed youth. The randomized phase 3 trial found that teplizumab did achieve this, but that trial also suggested that there was improvement in other clinical parameters including reduced reliance on insulin medications, higher grade hypoglycemia, time in range of glucose, and quality of life. The researchers published their findings in the New England Journal of Medicine on October 18.
Importantly, unlike other immune therapies for type 1 diabetes, teplizumab is not a chronic immune suppressant—it only requires two courses rather than continuous use. “This fulfills what we say in immunology as ‘operational tolerance,’” explains Herold. “In other words, you’ve given something for a brief period of time, and you fundamentally change the autoimmune response without continuously suppressing the immune system.”
At Yale, Herold’s team is exploring the therapeutic implications of the PROTECT trial. For instance, the researchers have also been involved in using beta cells derived from stem cells to replace those that have been destroyed by autoimmune processes. However, this process presents an obstacle—the body can similarly wipe out the replacement beta cells. Pairing this therapy with teplizumab could be a solution. “If teplizumab could stop the destruction of the replaced beta cells, we could help to restore normal metabolism in our patients,” says Herold.
TrialNet, a NIDDK-sponsored research consortium, has ongoing trials, including trials evaluating the use of antithymocyte globulin (ATG), JAK inhibitors, and the combination of the biological therapies rituximab and abatacept in preventing and slowing the onset of type 1 diabetes. “There are a lot of opportunities here to try and come up with improved therapies for these diseases,” says Herold.
TrialNet: Teplizumab Participant Resources
Hello. I am Dr. Kevan Herold a Professor of Immunobiology and Medicine at Yale University.
As a TrialNet Principal Investigator and the Chair of the Teplizumab/Anti-CD3 prevention trial, I’m excited to share with you the results of the study with you. Before I begin, I first want to say thank you to our study participants and their families for the vital role they played in this important research. Without your contribution, advancements in diabetes research would not be possible.
New England Journal of Medicine: Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes
Teplizumab, a humanized monoclonal antibody to CD3 on T cells, is approved by the Food and Drug Administration to delay the onset of clinical type 1 diabetes (stage 3) in patients 8 years of age or older with preclinical (stage 2) disease. Whether treatment with intravenous teplizumab in patients with newly diagnosed type 1 diabetes can prevent disease progression is unknown.
FAQs about teplizumab
Teplizumab is an immunotherapy drug, which has just been approved by the USA’s Food and Drug Administration (FDA) to delay type 1 diabetes. It helps to protect the insulin-producing beta cells from the immune attack that causes type 1 by attaching to markers on a type of immune cell called T-cells. Teplizumab has been shown to delay the development of type 1 in at-risk individuals by an average of three years.
Personal Notes
My CGM says
- GMI 6.8 ← not bad
- Time in range 88% ← not bad, but I’ve had better
- Average glucose 146 ← too high; 105 is the target
- One low glucose event this week
Novolog is working well for me. I had to adjust doses downward from those listed in the package insert.
Waffle cushion prices have recently fallen dramatically. I bought several more to try out in bed and at the dining table.
Exercise can improve circulation and thus hold back stage 1 neuropathy, so I do 100 toe bounces and fist clenches (a judo exercise) every day.
Exercise can bring down blood glucose steadily. I need to run some experiments to quantify that for myself. It turns out on the first trial that I can use our neglected stationary bike for 20 minutes, bringing my glucose level down from 165 to 127 while riding, and continuing to fall after that down to the low 90s. So then I ate some carbs to stabilize. I will see how much such exercise can let me stay in the 90-120 range.
I didn’t think I could do 20 minutes, because I get winded just walking. Color me surprised and gratified.
Well, then, I should have a really good report for you next Wednesday, if this holds up.
Late Addition
Well, the second experiment turned out quite differently. My blood glucose was shooting up, and I did 20 minutes on the bike. It kept going up the whole time, to more than 200. So I took an insulin shot, and it is down to just below normal now.
And how are you doing?