Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 12-month, randomized, single-blind, placebo-controlled exposure-response study of TCD601 (siplizumab) in new onset type 1 diabetes patients (STRIDE)

This research study, called STRIDE, is investigating a new treatment (TCD601, also known as siplizumab) for type 1 diabetes in people who have recently been diagnosed. Type 1 diabetes happens when the body's immune system mistakenly attacks cells in the pancreas that make insulin. The study aims to see if siplizumab can help these cells continue to produce insulin. Participants will get either the new drug or a dummy treatment (placebo), and doctors will monitor their health closely over 12 months. This is a Phase II study, meaning it's still in the earlier stages of drug development, looking for the best dose and how well it works and ensuring it's safe. It's a key step in understanding if this treatment could benefit people with type 1 diabetes in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Itb-Med AB

Enrolment target

113

Start

21 Sep 2023

New onset type I diabetes

What is this study about?

This study, called STRIDE, is exploring a new treatment for people who have just been diagnosed with type 1 diabetes. When you have type 1 diabetes, your body's immune system mistakenly attacks and destroys the cells in your pancreas that make insulin. Insulin is a hormone that helps your body use sugar for energy.

The main goal of this study is to see if a new medication called TCD601 (siplizumab), can help preserve the body's natural ability to make insulin. Researchers will compare how much insulin people are still making after 12 months when taking siplizumab, compared to those taking a dummy treatment (a ‘placebo’) that contains no active drug. This is important because even a small amount of natural insulin production can make managing type 1 diabetes easier.

This study is in Phase II, which means it’s an early but important step in checking if the new medication is safe and effective. It involves careful monitoring of participants' health, including blood sugar levels, insulin use, and any side effects, to understand how the treatment works in the real world. The hope is that treatments like TCD601 could one day help people with type 1 diabetes keep more of their natural insulin production for longer.

Key takeaways

Exploring a new treatment (TCD601/siplizumab) for recently diagnosed type 1 diabetes.
Aims to help preserve the body's natural insulin production.
Compares the new drug to a dummy treatment (placebo).
Participation lasts 12 months, with regular health check-ups.
This is an early-stage study (Phase II) looking at safety and effectiveness.
Open to adults aged 18 and over, of any gender.

Who may be eligible?

This study is looking for adults who have recently been diagnosed with type 1 diabetes. You need to be 18 years old or older to take part, and there's no upper age limit. Both men and women are welcome to participate.

The study is specifically for people who are in the early stages of type 1 diabetes. This means if you've had type 1 diabetes for a longer time, this particular study might not be suitable for you.

There will also be other specific medical checks and criteria that doctors will need to review to make sure the study is a safe and good fit for you. For example, they'll check your general health and other conditions you might have.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with type 1 diabetes only recently?
Are you able to attend regular clinic visits for over a year?
Are you comfortable with receiving either the study drug or a dummy treatment?
Do you want to contribute to research in type 1 diabetes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either the new study drug (siplizumab) or a dummy treatment (placebo). This means neither you nor your study doctor will know which one you are getting. You will take the study treatment for 12 months. During this time, you'll have regular visits to the study clinic where doctors will monitor your health very closely. These visits will involve blood tests to check your insulin production, blood sugar levels (including HbA1c and continuous glucose monitoring), and to look for any side effects. They will also track how much insulin you are using and any low blood sugar episodes. You will also have assessments for general health and safety, such as checks for infections. You might be given common pain relievers or allergy medication if needed during the study. After the main treatment period, there will be follow-up observations to continue monitoring your health, bringing the total duration of your participation to over 12 months.

Potential risks and benefits

Taking part in this study might offer a potential benefit by helping to preserve your body's natural insulin production. However, there's no guarantee that the study drug will work for you. As with any medication, there are potential risks, including side effects from the study drug. These will be carefully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden
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Unverified
Belgium
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Unverified
Italy
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Unverified
Spain

Common questions

What is type 1 diabetes?

Type 1 diabetes is a condition where your body's immune system attacks the cells in your pancreas that make insulin, meaning your body stops producing enough insulin on its own.

What is 'new onset' type 1 diabetes?

This means you have only recently been diagnosed with type 1 diabetes, typically within a few weeks or months, as specified by the study.

What does 'placebo-controlled' mean?

It means some participants will receive the active study drug, while others will receive a dummy treatment (placebo) that looks identical but contains no medicine. This helps researchers compare the drug's effects accurately.

What is C-Peptide AUC?

C-Peptide is a substance made at the same time as insulin. Measuring its levels over time (AUC means 'Area Under the Curve') helps doctors understand how much insulin your body is still producing.

What phase is this study in?

This is a Phase II study. This means it's an earlier stage of research, where doctors are looking at how safe the drug is and how well it works, to decide if it should be tested in more people.