Study Name: A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).
Principal Investigator: Laura Jacobsen, M.D.
What is the Precise ATG+Verapamil T1D study?
SAB BIO is developing a new medicine called SAB-142 to delay the progression of T1D. SAB-142 is a human antibody that is being tested to measure how it modifies the body’s immune system to preserve beta cells and helps the body regulate blood sugar.
The SAFEGUARD study aims to evaluate the safety and efficacy of SAB-142 in delaying the onset and progression of T1D, by stopping the body from mistakenly attacking insulin producing cells (beta cells) in the pancreas. Insulin helps the body regulate blood sugar (glucose).
The goal is to help prevent further damage to the body’s insulin producing cells.
Who can participate?
- Participants who are between 5 and 40 years old
- Have recently been diagnosed with T1D (enrolled into the study within 100 days of diagnosis)
- Weigh at least 16kg
What does participation in SAFEGUARD look like
The SAFEGUARD study will include approximately 159 participants around the world and will last about 15 months from the time of screening until the end of the study. If you/your child decide to take part, participation will include the following stages:
Screening:
Fasting 2 hour MMTT (Mixed Meal Tolerance Test)
Blood work
Treatment:
Depending on when you/your child enrolls into the study, you/they will be assigned to either Part A or Part B treatment
Part A treatment: You/your child will be assigned at random (like the flip of a coin) to 1 of 2 groups to receive:
- A high dose of SAB-142 (study medicine)
- A low dose of SAB-142 (study medicine)
Part B treatment: You/your child will be assigned at random (like the flip of a coin) to 1 of 3 groups to receive:
- A high dose SAB 142 (study medicine)
- A low dose SAB-142 (study medicine)
- A dose of placebo (a substance that looks like the study medicine but contains no active ingredients).
For both Part A and Part B, all groups will receive 2 treatment courses, 6 months apart. Each treatment course will be given via intravenous infusion (i.e. via a small tube placed into a vein) 2 days in a row.
Follow-Up
(7 clinic visits and 3 phone calls): After each treatment, you/your child will be required to have scheduled follow-up visits and calls to help us keep track of your/their health and monitor the safety and efficacy of the treatment.
Want to learn more?
Call (352) 294-5760 or email our Study Coordinators: