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Study on Deferoxamine to Improve Hypoxia Response in Type 1 Diabetes Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Desferal on people with Type 1 Diabetes. Type 1 Diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels. The study aims to see if Desferal can help improve how patients with this condition respond to low oxygen levels, a situation known as hypoxia.

Participants in the study will receive Desferal, which is given as an injection or infusion, meaning it is administered directly into the bloodstream. The study is designed to compare the effects of Desferal with a placebo, which is a substance with no active medication. This comparison helps researchers understand the true effects of Desferal. The study will follow a cross-over design, meaning participants will receive both Desferal and the placebo at different times during the study.

The main goal of the study is to determine if Desferal can improve the body's response to hypoxia in patients with Type 1 Diabetes. This involves monitoring changes in certain cells and substances in the blood that are related to blood vessel growth and oxygen levels. The study will also look at various heart and lung functions to see how they are affected by the treatment. The trial is expected to continue until the end of 2026.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Introduction to the trial

    Upon joining the study, the patient will receive an overview of the trial's purpose, which is to assess the effect of deferoxamine on the body's response to low oxygen levels in individuals with type 1 diabetes.

    The patient will be informed about the study's design, which is randomised, double-blind, placebo-controlled, and cross-over, meaning that participants will receive both the active treatment and a placebo at different times.

  2. Step 2

    Medication administration

    The patient will receive Desferal (deferoxamine mesilate) as a solution for injection or infusion. This medication will be administered intravenously.

    The dosage and frequency of administration will be determined by the study protocol, ensuring the patient receives the correct amount to evaluate the treatment's effectiveness.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient will undergo regular monitoring to assess the number of endothelial precursor cells in the blood after exposure to intermittent low oxygen levels.

    Additional assessments will include measuring changes in specific proteins and genes related to blood vessel growth and oxygen response, as well as evaluating heart and lung function through various physiological parameters.

  4. Step 4

    Completion of the trial

    The trial is expected to conclude by December 26, 2026. Upon completion, the patient will have a final assessment to gather all necessary data.

    The patient will be informed of the study's outcomes and any potential implications for future treatment options for type 1 diabetes.

Who can join the trial?

6 criteria

  • Patients must have **diabetes mellitus type 1**, which is a condition where the body cannot produce insulin, for a duration between 5 and 40 years.
  • Their **HbA1c** levels, which is a measure of blood sugar control over the past 2 to 3 months, should be between 55 and 100 mmol/mol.
  • They should be between the ages of 18 and 55.
  • They must have a normal **ECG** result, which is a test that checks for problems with the electrical activity of the heart, showing no signs of significant heart disorders.
  • Female participants must either be postmenopausal, surgically sterile, or if they are premenopausal and not surgically sterile, they must use a highly effective method of contraception during the study and for 30 days after the last visit. These methods include hormonal contraception that stops ovulation, an intrauterine device, a hormone-releasing system, having their fallopian tubes blocked, having a partner who has had a vasectomy, or practicing sexual abstinence.
  • Participants must provide signed informed consent, which means they agree to participate in the study after being informed about all aspects of the trial.

Who cannot join the trial?

4 criteria

  • Patients who do not have diabetes mellitus type 1 cannot participate. This is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
  • Patients who are not experiencing issues with their body's reaction to hypoxia cannot participate. Hypoxia is a condition where the body or a part of the body is not getting enough oxygen.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for participants within a certain age group.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Desferal: This medication is used in the trial to see if it can help improve how patients with type 1 diabetes respond to low oxygen levels. It is being tested to understand if it can make the body react better to situations where there is not enough oxygen, which can be a problem for people with diabetes.

What is already known about the treatment

Deferoxamine – Deferoxamine is administered systemically, often through injection, to help improve the body's response to low oxygen levels, particularly in patients with type 1 diabetes. It is currently being studied in clinical trials to assess its effectiveness in this area. The main therapeutic indication for deferoxamine in this context is to enhance the impaired reaction to hypoxia, which is a condition where the body or a region of the body is deprived of adequate oxygen supply. At the molecular level, deferoxamine works by binding to excess iron in the body, which can help reduce oxidative stress and improve cellular function under low oxygen conditions. It is classified pharmacologically as an iron chelator.

Investigated diseases

Diabetes Mellitus Type 1 – This is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in childhood or adolescence, but it can develop in adults. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. Over time, this leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. If not managed, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. Regular monitoring and management of blood sugar levels are crucial to managing the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519562-48-00Protocol codeDESIREDEstimated enrolment30 patientsSponsorKarolinska University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).