In 2022, the drug teplizumab (Tzield®) was approved to delay the need for insulin therapy in people living with stage 2 type 1 diabetes (T1D). Since then, screening efforts to detect early-stage T1D have grown. Opportunities for people with early-stage T1D to take part in clinical research have also increased. But research doesn’t stop with diagnosis. In fact, scientists are working hard to improve outcomes for people recently diagnosed with stage 3 T1D. 

The interval immediately after a T1D diagnosis is sometimes called a “honeymoon period.” During this temporary phase, many people still have functioning beta cells and continue to produce some insulin. This helps keep blood glucose levels in the target range, potentially lowering the risk of long-term complications. 

Although the autoimmune attack on functioning beta cells continues during this time, researchers are developing various strategies to extend the honeymoon period and slow the progression of T1D. Some try to block the immune response that damages beta cells. Others aim to protect beta cells or enhance their health. Any approach that slows the loss of beta cells could preserve insulin production, help stabilize glucose levels, and improve outcomes for people living with T1D. 

Here, we spotlight four clinical trials currently enrolling participants with recent-onset T1D. Read on to learn more about this research.  

 

Denosumab trial 

The Denosumab for Type 1 Diabetes trial studies a drug called denosumab (Prolia®), which is used to treat people with osteoporosis. Denosumab protects bones by deactivating a protein that can cause them to break down. Researchers believe that deactivating that same protein may also protect beta cells. 

Denosumab is injected under the skin by a healthcare professional. The denosumab trial is enrolling women ages 18-50 years and men ages 21-50 years. The lower age limit is different for women and men because their bones mature at different ages. Bone maturity is important in this trial because denosumab can affect bone growth. Participants must have been diagnosed with T1D between 1 and 5 years ago. The trial is taking place in Alabama, California, and Indiana. 

   

FABULINUS trial 

The FABULINUS trial involves a new candidate drug called frexalimab. Frexalimab was first developed to treat multiple sclerosis (MS) but has not yet been approved for use in the United States. It is an antibody that may help to block the immune response that contributes to autoimmunity in both MS and T1D.   

The first dose of frexalimab is usually given as an infusion. Later doses are injected under the skin. To enroll in the FABULINUS trial, you should be 12-35 years old and be taking insulin to treat T1D for 90 days or less. The trial is active in eight states (California, Colorado, Florida, Idaho, Illinois, Massachusetts, New York, and North Carolina), as well as in Canada and Europe. 

   

JAKPOT T1D trial 

In the  JAKPOT T1D trial, researchers are testing two different drugs: abrocitinib and ritlecitinib. These medications belong to a new class of autoimmune treatments called Janus kinase or JAK inhibitors. Abrocitinib is used to treat eczema. Ritlecitinib is being studied in several other autoimmune diseases. These include alopecia, ulcerative colitis, Crohn’s disease, vitiligo, and rheumatoid arthritis. 

Both abrocitinib and ritlecitinib come in pill forms, so you can take them by mouth. The JAKPOT trial is enrolling people 12-35 years old who were diagnosed with T1D in the past 3 months. There are sites located in 16 states in Australia and Canada. 

 

TADPOL trial 

The TADPOL trial is assessing a drug called difluoromethylornithine (DFMO). It is an effective treatment for African sleeping sickness. DFMO may also be useful in a rare type of cancer that affects nerve cells (called neuroblastoma). Scientists have been studying DFMO for years.   

In the TADPOL trial, DFMO is taken by mouth. Researchers are seeking participants between the ages of 4 and 40 years who were diagnosed with T1D within the past 100 days. Trial locations include Colorado, Indiana, Illinois, Michigan, Missouri, and Wisconsin. 

  

Want to learn more? 

You can find more information about these trials — such as how long they last — through the links above and at ClinicalTrials.gov. In addition, new trials start up regularly and offer more chances to participate in T1D clinical research.   

To stay up to date about such opportunities, join the T1D Exchange Registry today.