What is a clinical study?
Clinical studies are needed to develop new medicines. A clinical study is a type of research that tests how a new medicine acts in the body and affects a specific condition. A new medicine must be tested in clinical studies before it can be made available to communities.
Clinical studies must follow strict rules. They are reviewed and monitored closely to make sure that the rights of people taking part are protected, no unnecessary risks are involved, and that they help answer important medical questions.
Why is the SAFEGUARD clinical study being done?
The SAFEGUARD clinical study is being done to evaluate a new medicine (known as an investigational study medicine) to see if it works and is safe to treat T1D. The study medicine is called SAB-142. As SAB-142 is new, it means it has not been approved for general use by doctors and can only be used as part of this clinical study. This study is being done to see how well SAB-142 works, and how safe it is.
About T1D
Type 1 diabetes (T1D) is a condition where the body mistakenly attacks and destroys the beta cells in the pancreas that make insulin, the hormone that regulates blood sugar (glucose). Without enough insulin, too much sugar builds up in the blood, resulting in high blood sugar levels. This can cause many problems, so insulin needs to be monitored and managed carefully.
People with T1D need to take insulin every day in order to live and be healthy. SAB-142 has been developed to protect the remaining insulin-producing cells and help the body continue to make its own insulin.
What is the purpose of the SAFEGUARD clinical study?
The SAFEGUARD study is being conducted to see if SAB-142 works and is safe to treat T1D.
Who can participate in the SAFEGUARD study?
You/your child may qualify to participate in the SAFEGUARD clinical study if the following criteria are met:
- Aged between 5 to 40 years, inclusively
- Newly diagnosed with T1D (enrolled in the study within 100 days of diagnosis)
If you have questions about any requirements listed here, please talk to your/your child’s doctor. Additional eligibility requirements will be checked.
If you/your child qualify to participate:
You/they will be assigned to either Part A or Part B treatment, depending on when you/they are enrolled into the study.
- 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) over 2 days.
There will be 7 scheduled follow-up visits and 3 phone calls to monitor the safety and efficacy of the treatment.
You/your child will NOT be charged for the study medicine or placebo, study visits, or tests and procedures needed for the study.
You/your child are free to leave the study at any time.
