A Study of SAB-142 to Slow the Progression of Type 1 Diabetes in Adults and Children Recently Diagnosed with the Disease

1 1

What is this study about?

This study is looking at Type 1 Diabetes, a condition where the body’s immune system attacks and destroys the cells in the pancreas that make insulin, a hormone that helps control blood sugar levels. The study will test a treatment called SAB-142, which is a solution given through a vein, along with a placebo. SAB-142 contains human polyclonal immunoglobulin G against thymocyte, which is a type of antibody that may help protect the insulin-producing cells from being destroyed. Some participants will receive SAB-142 at different dose levels, while others will receive sodium chloride, which is a salt solution used as placebo.

The purpose of this study is to learn about the safety and tolerability of two different treatment plans in people who have recently been diagnosed with Stage 3 Type 1 Diabetes, and to find out whether the study treatment can help slow down the loss of insulin-producing cells in the pancreas over time. The study will also look at how well blood sugar levels are controlled, including information gathered from devices that continuously monitor glucose.

During the study, participants will receive the treatment through intravenous administration, which means the medicine will be given directly into a vein. The treatment period will last for several months, and participants will be monitored regularly for any side effects or health problems that may occur. Doctors will also check how well the pancreas is working and measure insulin production throughout the study. The study is designed to compare different dose levels of SAB-142 with placebo to determine which approach works best and is safest for people with newly diagnosed Type 1 Diabetes.

1 Treatment assignment and preparation

Upon joining the study, you will be randomly assigned to one of three groups. This process is called randomisation and ensures that the assignment is done by chance, similar to flipping a coin.

One group will receive a low dose of SAB-142, another group will receive a high dose of SAB-142, and the third group will receive a placebo. A placebo is an inactive substance that looks like the real treatment but contains no active medicine.

Neither you nor your doctor will know which treatment you are receiving during the study. This is called a double-blind design and helps ensure accurate results.

2 Receiving the study treatment

You will receive the assigned treatment through an intravenous infusion. This means the medicine will be given directly into your vein through a small tube inserted into your arm.

The treatment product is SAB-142, which contains human polyclonal immunoglobulin g against thymocyte, or sodium chloride solution if you are in the placebo group.

The solution will be administered as an infusion, which means it will drip slowly into your vein over a period of time.

The specific dose you receive will depend on which treatment group you are assigned to. The study is designed to compare two different dose levels of SAB-142 against placebo to determine which works best.

3 Monitoring for side effects and health problems

Throughout the study, any health problems or side effects you experience will be recorded and reviewed by the study team.

This monitoring is important to understand the safety and tolerability of the treatment, which means how well your body handles the medicine and whether it causes any unwanted effects.

4 Assessment of pancreas function

Your pancreas function will be checked regularly during the study. The pancreas is the organ that produces insulin, a hormone that helps control blood sugar levels.

These checks will measure how well your pancreas is producing insulin. The purpose is to see whether the treatment can help slow the decline of insulin-producing cells in your pancreas.

This is one of the main goals of the study, as preserving these cells may help manage type 1 diabetes better over time.

5 Blood sugar monitoring

Your blood sugar control will be monitored throughout the study. This includes regular measurements to see how well your blood sugar levels are being managed.

You may be asked to use a continuous glucose monitoring device. This is a small device that tracks your blood sugar levels throughout the day and night without needing frequent finger pricks.

The information from this monitoring will help assess how the treatment affects your diabetes management.

6 Study duration and follow-up

The study is expected to continue until March 2029. During this time, you will have regular visits and assessments as scheduled by the study protocol.

Throughout the study period, you must not participate in other experimental treatments or clinical trials.

The extended duration allows for proper evaluation of how the treatment affects the progression of type 1 diabetes over time.

Who Can Join the Study?

You must be up to 40 years old and recently diagnosed with Stage 3 type 1 diabetes, which means your body has started showing clear signs that it cannot properly control blood sugar levels
You must be up to date with all vaccines that are required by your local or national health authorities
If you are female, you must meet conditions that prevent pregnancy during the study, for example: you have not yet started your menstrual periods, you have gone through menopause which means your monthly periods have stopped permanently, you have had certain surgeries that prevent pregnancy, or you are using reliable birth control methods to prevent pregnancy
You must have a positive test result for at least one antibody linked to type 1 diabetes, which are proteins in your blood that indicate your immune system is attacking the cells that make insulin in your pancreas
You must agree not to take part in other experimental treatments during the study

Who Cannot Join the Study?

The study information does not list specific reasons why patients cannot participate in this clinical trial
If you have been recently diagnosed with Type 1 Diabetes, which is a condition where the body cannot produce enough insulin (a substance that helps control blood sugar levels), you may want to discuss with your doctor whether this study could be suitable for you
The study is looking at the safety of treatments and whether they can help protect the cells in the pancreas (an organ in your body) that make insulin
The study accepts both male and female participants
The study includes adults and children as participants

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Hannoversche Kinderheilanstalt	Hanover	Germany
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Instytut Diabetologii Sp. z o.o.	Warsaw	Poland
Steno Diabetes Center Copenhagen	Herlev	Denmark
Hospital Universitario Virgen Macarena	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Hospital Universitario De Cruces	Barakaldo	Spain
Turku University Hospital	Turku	Finland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
CHC MontLegia	Liege	Belgium
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
University Medical Center Ljubljana	Ljubljana	Slovenia
Hopital Beaujon	Clichy	France
Vrije Universiteit Brussel	Jette	Belgium
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Ucwreflrcuvftzvbdsjeq Auwjqkau	Augsburg	Germany
Sffiwqh Kpoqtzhev Ieh Kozysw Jjbiopfvu Uuyvxsogybbf Mwkbrigcpj Ifg Kqbqwh Mnpaytdasapfngq W Pmoyvjzj	Poznan	Poland
Hxkstevs Uaichaxswb Cnlkvfd Hajvqliu	Helsinki	Finland
Mybucib Uytkjyruvz Oz Gfwx	Graz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	05.03.2026
Belgium	Recruiting	05.03.2026
Denmark	Recruiting	05.03.2026
Finland	Recruiting	05.03.2026
France	Recruiting	05.03.2026
Germany	Recruiting	05.03.2026
Italy	Recruiting	05.03.2026
Lithuania	Recruiting	05.03.2026
Poland	Recruiting	05.03.2026
Slovenia	Recruiting	05.03.2026
Spain	Recruiting	05.03.2026

Trial locations

Investigated drugs:

SAB-142 is an investigational medication being studied to see if it can help slow down the progression of type 1 diabetes in people who have recently been diagnosed. The study is testing whether this treatment can help protect the cells in the pancreas that produce insulin, which are damaged in type 1 diabetes. Researchers want to learn if SAB-142 is safe and well-tolerated, and if it can delay the worsening of the disease.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of SAB-142 against no active treatment, which helps researchers determine if the medication is truly effective.

Type 1 Diabetes – Type 1 diabetes is a condition where the body’s immune system attacks and destroys the insulin-producing cells in the pancreas. Without enough insulin, the body cannot properly control blood sugar levels, causing glucose to build up in the bloodstream. This disease typically develops quickly over weeks or months, often appearing in childhood or young adulthood, though it can occur at any age. As the condition progresses, the pancreas produces less and less insulin until very little or none remains. People with this condition experience symptoms such as increased thirst, frequent urination, extreme hunger, weight loss, and fatigue. The disease requires lifelong management to maintain healthy blood sugar levels and prevent complications affecting various organs and body systems.

Trial ID:

2025-521560-36-00

Protocol code:

SAB-142-201

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A Study of SAB-142 to Slow the Progression of Type 1 Diabetes in Adults and Children Recently Diagnosed with the Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?