What is FABULINUS?

The FABULINUS Study is a clinical research study testing an investigational study drug called frexalimab in adolescents and adults 12 to 35 years old with newly diagnosed type 1 diabetes who have been taking insulin for 90 days or less.

You can help researchers understand whether the investigational study drug, frexalimab:

  • Can preserve the body’s own insulin production.
  • Can help the body control the levels of glucose.
  • Can decrease the dose of insulin.
  • Is safe to take.

How may an investigational study drug for people recently diagnosed with type 1 diabetes help preserve the body's own insulin production?

Watch the video to learn more about type 1 diabetes and how the investigational study drug, frexalimab, may help preserve the body’s own insulin production.

What treatment will I receive?

You will be put into a group by chance (randomization) to receive either the investigational study drug, frexalimab, or placebo.

The placebo looks just like the investigational study drug Frexalimab but does not contain any real medicine. It is used to better see the effect of the investigational study drug being tested (frexalimab) compared with having no medicine. You and the study doctor will not know if you are in the group receiving the investigational study drug or in the group receiving the placebo. This is done to make sure that the study results are not influenced in any way. (to be consistent with planner). Your chances of receiving frexalimab are 2 out of 3. Talk to your doctor for more information on how the investigational study drug is administered. You will also continue taking your insulin therapy as recommended by your doctor.

What happens
during the study?

The study lasts about 2.5 years (135 weeks). It is divided into 3 parts: Screening, Study Treatment Period, and Follow-up. During the study, you will visit the study site for tests and health checks. The study team will also call you between onsite visits to see how you’re doing. Your health will be monitored throughout the study for any side effects that may happen.

1. Screening

To see if you qualify for the study, the study team will ask questions about your health and the medicines you take and run some tests. 

2. Treatment

You will receive the investigational study drug or placebo for up to 2 years and have 11 visits to the study site for tests and health checks.

3. Follow-Up

After your final dose of investigational study drug or placebo, you will have 2 visits to check on your health.

What kind of tests and health checks will I have?

During the study you will have on-site visits for tests and health checks. You will not have all these tests at every visit. There may also be additional tests. Talk to the study doctor for more information. 

Review insulin dose

Review blood sugar/CGM numbers

Physical exam/vital signs

Height/weight

Standard meal test

Glucose control test (A1c)

Heart activity (electrocardiogram, ECG)

Blood test

Urine test

Questionnaires

Side effect check

Patient app review

A1c = glycated hemoglobin; CGM = continuous glucose monitoring

Is there anything else I will have to do during the study?

You will be given a phone with 2 patient apps to keep track of when your investigational study drug or placebo is administered, your insulin dose, and other treatments that you may have. You will also use the apps to add adverse events (including hypoglycemia and hyperglycemia), and record the results of pregnancy tests (if applicable). These apps also have questionnaires for you to complete. You will answer questions about how you are feeling, your ability to do daily activities, your treatment, and how you feel about your T1D.

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