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Type 1 diabetes mellitus – Trials in Disease

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Clinical Trials for Type 1 Diabetes Mellitus

Currently, 29 clinical trials are investigating new treatments for type 1 diabetes mellitus. These studies are testing various approaches including medications to preserve insulin-producing cells, immune system therapies, vaccines, and combination treatments. The trials involve participants across different age groups and are being conducted in multiple countries throughout Europe and beyond.

Clinical trial locations

Evaluation of fenofibrate treatment on beta cell function in children and adolescents newly diagnosed with type 1 diabetes

This study focuses on young people aged 10 to 17 who have been recently diagnosed with the condition, specifically within eight weeks of diagnosis. The research evaluates how fenofibrate, a medication that affects fat metabolism, might help preserve the function of insulin-producing beta cells in the pancreas.

To participate, individuals must be between 10 and 17 years old and have been diagnosed according to Polish Diabetes Association criteria. Both the participant and their legal representative must be able to understand and sign informed consent forms. For female participants, a negative pregnancy test is required at the first visit, and effective birth control must be used throughout the study.

Participants cannot join if they are outside the specified age range, have other types of diabetes besides type 1, have severe kidney or liver problems, or have been diagnosed with type 1 diabetes more than six weeks ago. Those with known allergies to fenofibrate, history of pancreatitis, or serious medical conditions that could affect study results are also excluded.

The study compares two groups of participants – one receiving fenofibrate tablets and another receiving a placebo. The medication is taken orally once daily at a dose of 160 mg for up to 52 weeks. Throughout the study, researchers monitor various aspects including blood sugar levels, insulin requirements, and markers of inflammation. The main goal is to determine if fenofibrate can help maintain the remaining function of beta cells in young patients with newly diagnosed disease.

Investigational drug: Fenofibrate is a medication that helps control blood fat levels and is being studied to see if it can help preserve the function of insulin-producing cells in the pancreas.

Study of Tirzepatide for Adults with Type 1 Diabetes and Obesity or Overweight

This trial is studying the effects of tirzepatide in adults who have the condition and are either overweight or have obesity. The study compares tirzepatide, given as a solution for injection in a pre-filled pen, to a placebo.

To be eligible, participants must have had the condition and been on insulin treatment for at least one year. They must have blood glucose levels within allowed limits for study participation, be at least 18 years old, and have obesity or be overweight.

The medication is taken once a week and works by helping the body manage insulin and sugar levels more effectively. The purpose is to see if tirzepatide can better control blood sugar levels compared to placebo. Participants receive injections once a week for 40 weeks.

The study is designed to be double-blind, meaning neither participants nor researchers know who receives tirzepatide and who receives placebo. The main goal is to observe changes in Hemoglobin A1c (HbA1c), which reflects average blood sugar levels over the past two to three months.

Investigational drug: Tirzepatide is a medication being studied for its potential to help control blood sugar levels in people with the condition who are also overweight or have obesity.

Study on Anti-T Lymphocyte Immunoglobulin for Children and Young Adults with Recent Type 1 Diabetes to Preserve Beta Cell Function

This study aims to explore the effectiveness and safety of a treatment called Grafalon, which contains anti-T lymphocyte immunoglobulin for human use, rabbit. The treatment is given as a solution through an infusion directly into the bloodstream.

The purpose is to see if Grafalon can help prevent the loss of remaining insulin-producing cells in children and young adults who have been recently diagnosed. Participants must have been diagnosed with the condition and be within the age range of children and teenagers. Both males and females can participate, and participants should not belong to a vulnerable population group.

Participants receive either Grafalon treatment or a placebo in a double-blind design, meaning neither participants nor researchers know who receives the actual treatment or placebo. Throughout the study, participants are monitored over a period of time to assess how their bodies respond to treatment.

Regular check-ups and tests measure the function of insulin-producing cells and other health indicators. The study will help determine the best dosage of Grafalon for treating the condition in young patients and aims to provide valuable insights into managing the condition more effectively.

Investigational drug: Grafalon is a medication designed to prevent the loss of the body’s ability to produce insulin by protecting the cells in the pancreas that make insulin.

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

This study aims to see if Desferal can help improve how patients with the condition respond to low oxygen levels, a situation known as hypoxia. Participants receive Desferal, which is given as an injection or infusion directly into the bloodstream.

To participate, patients must have had diabetes mellitus for a duration between 5 and 40 years. Their HbA1c levels should be between 55 and 100 mmol/mol, and they should be between 18 and 55 years old. They must have a normal ECG result and, if female and of childbearing potential, must use a highly effective method of contraception.

The study is designed to compare the effects of Desferal with a placebo in a cross-over design, meaning participants receive both Desferal and placebo at different times during the study. The main goal is to determine if Desferal can improve the body’s response to hypoxia in patients with the condition.

This involves monitoring changes in certain cells and substances in the blood related to blood vessel growth and oxygen levels. The study also looks at various heart and lung functions to see how they are affected by treatment.

Investigational drug: Desferal is being studied to see if it can help improve the body’s response to low oxygen levels in patients with the condition.

Study on Frexalimab for Preserving Insulin Production in Newly Diagnosed Type 1 Diabetes Patients Aged 12-21 on Insulin Therapy

This trial will explore the effects of a new treatment called Frexalimab, which is a type of medication known as a monoclonal antibody. This medication is designed to help preserve the function of the pancreas in producing insulin.

Participants must have been diagnosed according to the American Diabetes Association criteria and started insulin replacement therapy no more than 90 days before the first screening visit. They must test positive for at least one specific diabetes-related autoantibody and have a random C-peptide level of at least 0.2 nmol/L at screening.

Participants receive either Frexalimab or a placebo, in addition to their regular insulin therapy. The study lasts for 104 weeks, which is about two years, during which participants receive treatment and are monitored regularly to see how their bodies respond.

Throughout the study, participants undergo various tests and assessments to measure how well their pancreas is functioning and how their condition is being managed. The goal is to see if Frexalimab can help maintain insulin production and improve overall management compared to those who receive placebo.

Investigational drug: Frexalimab is a type of medication known as a monoclonal antibody that works by targeting a specific protein in the body called CD40L. By blocking it, frexalimab may help protect the insulin-producing cells in the pancreas.

Study on Insulin Lispro and Insulin Human for Managing Blood Sugar After Meals in Type 1 Diabetes Patients with Different Gastric Emptying Rates

This study is testing different fast-acting insulin treatments including Lyumjev, Humalog, and Huminsulin. These insulins are designed to help manage blood sugar levels after meals.

To participate, individuals must have the condition, with an HbA1c level between 6.0% and 8.0%, be in generally good health, aged between 18 and 80 years, and have a body mass index (BMI) between 18.5 and 35 kg/m².

Participants receive one of the insulin treatments through a subcutaneous injection. The study observes how these insulins affect blood sugar levels after meals and how they might influence the production of certain substances in the body that can cause stress to cells.

The main goal is to find the best insulin option that can help control blood sugar levels effectively after eating, while also considering how quickly the stomach empties food into the intestines. The study will look at how the speed of stomach emptying affects blood sugar control with these insulins.

Investigational drugs: Insulin Lispro, Insulin Aspart, and Insulin Glulisine are fast-acting insulins used to control blood sugar levels in people with the condition. They help manage the rise in blood sugar that occurs after eating.

Study on Low-Dose Aldesleukin and Ciclosporin for Patients with Newly Diagnosed Type 1 Diabetes Retaining Insulin Secretion

This study involves two main treatments: ILT-101, also known as Aldesleukin, which is given as a solution for injection, and Ciclosporin, a medication taken orally. There is also a placebo involved in the study.

To participate, individuals must be between 16 and 45 years old, diagnosed with the condition according to American Diabetes Association criteria with at least one positive autoantibody, and have been diagnosed within the last 3 months. They must have a fasting C-peptide level of at least 0.1 nmol/L and use effective contraception throughout the study.

Participants first receive Ciclosporin for two months. Following this, they receive ILT-101 or a placebo for a period of time. The study monitors changes in the immune system, specifically looking at a type of white blood cell called Tregs, which play a role in regulating the immune response.

Throughout the study, participants have regular check-ups to assess their health and monitor any changes in their condition. The study tracks the evolution of insulin production and any side effects from the treatments.

Investigational drugs: Interleukin-2 (IL-2) is a medication used in low doses to study its effects on the immune system, particularly a type of white blood cell called Tregs lymphocytes. Ciclosporin is an immunosuppressant that helps reduce the activity of the immune system.

Study on Reducing Cardiovascular Disease in Type 1 Diabetes Patients Using Finerenone and Semaglutide

This study explores new treatments for reducing cardiovascular disease in individuals with the condition. The study involves Finerenone, also known by its code name BAY 94-8862, which is taken as a film-coated tablet. Additionally, the study involves the use of Ozempic, a solution for injection that contains the active substance Semaglutide, and Sotagliflozin.

To participate, individuals must provide written consent, be at least 40 years old, have had the condition for over 10 years, and meet specific health criteria such as chronic kidney disease or a history of heart disease. Females who can have children must use highly effective birth control methods during the study.

The purpose of the study is to test a strategy of intensified care for people at high risk of cardiovascular disease. This involves setting ambitious treatment goals compared to standard care. The study investigates the safety and effectiveness of 40 mg of Finerenone in reducing the risk of cardiovascular death and hospitalization for heart failure.

Participants receive either the new treatment strategy or standard care, and some may receive a placebo. The study lasts for 60 weeks, during which participants are monitored for any major adverse cardiovascular events.

Investigational drug: Finerenone is a medication being tested for its safety and effectiveness in people at risk of cardiovascular death and hospitalization due to heart failure.

Study on Sotagliflozin for Slowing Kidney Disease in Type 1 Diabetes Patients

This trial focuses on studying the effects of a medication called sotagliflozin in people with the condition who also have chronic kidney complications. Sotagliflozin is a type of drug known as a dual inhibitor of SGLT1 and SGLT2.

To participate, individuals must be an adult with the condition, have Chronic Kidney Disease, and have albuminuria. Both men and women can participate.

Participants in the study receive either sotagliflozin or a placebo. The study lasts for about three months, during which the effects of the medication on kidney health are monitored using a special imaging technique called MRI to measure how well the kidneys are being supplied with oxygen.

The goal is to see if sotagliflozin can improve kidney oxygenation compared to placebo. The study aims to provide valuable insights into how long-term use of sotagliflozin might help manage kidney health in people with the condition and chronic kidney disease.

Investigational drug: Sotagliflozin is a medication being studied for its potential to help protect the kidneys in people with the condition and chronic kidney disease by affecting kidney oxygen levels over a three-month period.

Study on the Effect of Influenza Vaccine on Preserving Beta Cell Function in Early Type 1 Diabetes Patients

The INVITED trial is investigating whether the Vaxigrip Tetra vaccine, which is a type of flu shot, can help preserve the function of insulin-producing cells in people who have recently been diagnosed with the condition. The vaccine is given as an injection into the muscle.

To participate, patients must have been hospitalized with newly diagnosed condition. Both male and female participants are eligible. Participants must be 7 years old or older but younger than 18 years. Written informed consent is required from parents or a legal guardian.

Participants in the study receive either the flu vaccine or a placebo. The study tracks changes in the body’s ability to produce insulin over a period of 12 months. This is measured by looking at levels of a substance called C-peptide, which indicates how well the pancreas is working.

Throughout the study, participants have regular check-ups to monitor their health and the effects of the vaccine. The study aims to provide valuable information on whether the flu vaccine can be a helpful treatment in managing early condition by preserving the function of insulin-producing cells.

Investigational drug: Influenza Vaccine is a type of vaccine designed to protect against the influenza virus. In this trial, it is being used to see if it can help preserve the function of certain cells in the pancreas that produce insulin.

Summary

The 29 clinical trials for type 1 diabetes show diverse research approaches across Europe and internationally. A notable concentration of trials is occurring in Germany and Sweden, which each host multiple studies. France, Italy, Belgium, and Spain also feature prominently as trial locations, indicating strong European participation in diabetes research.

Several medications appear repeatedly across trials, with Verapamil being studied in multiple formats for preserving beta-cell function in different age groups. The trials demonstrate a clear research focus on preserving remaining insulin production in newly diagnosed patients, particularly within the first few months after diagnosis. This timing appears critical across many studies.

Immunomodulatory approaches are well-represented, with multiple trials testing medications that affect the immune system, including Frexalimab, Siplizumab, and various interleukin-based therapies. Some trials also explore repurposing existing medications, such as colchicine and aspirin, for reducing inflammation and cardiovascular complications.

The trials span various age groups, from children as young as 4 years to adults up to 80 years, with several studies specifically targeting pediatric and adolescent populations. Many trials require participants to have been recently diagnosed, typically within 100-180 days of starting insulin therapy, and to still maintain some level of insulin production as measured by C-peptide levels.

Ongoing Clinical Trials on Type 1 diabetes mellitus

  • Study of Colchicine to Reduce Complications in People with Type 1 Diabetes and High Blood Sugar Variability

    Recruiting

    1 1 1
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    The Netherlands

  • Using glucagon and automated insulin delivery to prevent low blood sugar during exercise in adults with type 1 diabetes

    Recruiting

    1 1 1 1
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    Denmark

  • A Study of Baricitinib to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes

    Recruiting

    1 1 1
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    Belgium Czechia Finland France Germany Italy +6

  • A Study of Baricitinib to Delay Type 1 Diabetes in Children and Adults at Risk of Developing the Disease

    Recruiting

    1 1 1
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    Belgium Finland France Germany Italy The Netherlands +5

  • Comparing weekly insulin icodec and daily insulin glargine with insulin aspart in adults with type 1 diabetes: a 26-week study of blood sugar control

    Recruiting

    1 1 1 1
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    Germany Poland Romania Slovakia

  • Study of IMMUNOSTEM gene therapy using modified stem cells for newly diagnosed patients with type 1 diabetes who still produce insulin

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    1 1
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    Italy

  • Study of colchicine to improve insulin sensitivity in adults with type 1 diabetes who have low-grade inflammation

    Recruiting

    1 1
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    Denmark

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

    Recruiting

    1 1
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    Sweden

  • Study on Verapamil to Preserve Insulin Secretion in Children with Recent Onset Type 1 Diabetes

    Recruiting

    1 1
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    Sweden

  • Study on Low-Dose Aldesleukin and Ciclosporin for Patients with Newly Diagnosed Type 1 Diabetes Retaining Insulin Secretion

    Recruiting

    1 1
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    France

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