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Clinical Trials in Diabetes Mellitus

There are currently 14 ongoing clinical trials investigating various treatments for diabetes mellitus, including trials for Type 1 and Type 2 diabetes, as well as related complications. These studies are testing medications ranging from insulin modifications and cell therapies to vaccines and bone health treatments, with trials being conducted across multiple European countries including Poland, Denmark, France, Spain, Germany, Italy, Netherlands, Belgium, Sweden, Austria, Norway, and Czechia.

Clinical trial locations

Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

This trial is investigating whether allopurinol, a medication typically used to lower uric acid levels in the blood, can help reduce serious heart and blood vessel problems in people with high cardiovascular risk. The study includes participants who have conditions such as high blood pressure, stroke history, heart failure, irregular heartbeat, and diabetes mellitus, as well as those experiencing long-COVID symptoms.

Main inclusion criteria: Participants must be between 40 and 70 years old and have elevated blood uric acid levels (above 5mg/dl). They also need to have at least one high-risk cardiovascular condition, such as documented history of stroke, heart failure, poor blood flow to legs, irregular heartbeat, or diabetes with organ damage showing as stiff blood vessels, enlarged heart muscle, or increased protein in urine.

Main exclusion criteria: People currently taking allopurinol or similar medications, those with known allergies to allopurinol, severe kidney or liver disease, active cancer, pregnancy or breastfeeding, life expectancy less than 12 months, severe mental illness, alcohol or drug dependency, or recent major surgery cannot participate.

Trial focus: The research examines whether allopurinol can prevent serious cardiovascular events such as heart attacks, strokes, or the need for heart-related procedures over a 5-year treatment period. Regular blood tests and heart examinations will be performed to monitor participants’ health throughout the study, which will continue until May 30, 2028.

Investigational drug: Allopurinol is a medication that lowers uric acid levels by blocking an enzyme that produces uric acid in the body. In this study, researchers believe it may help protect the heart and blood vessels.

Study of Denosumab Effects on Muscle Strength and Insulin Sensitivity in Patients with Postmenopausal Osteoporosis and Diabetes Mellitus

This clinical trial focuses on studying the effects of denosumab in postmenopausal women who have both Type 2 diabetes and osteoporosis. The medication is being investigated to understand how it affects muscle strength and the body’s response to insulin over a 12-month treatment period.

Main inclusion criteria: Participants must be postmenopausal women (no menstrual periods for at least two years) who are 40 years or older. They need to have a bone density T-score of -2.0 or higher, at least 2 vertebrae that can be examined using DXA scan, a diagnosis of Type 2 diabetes, and must be currently taking only metformin as their diabetes treatment.

Main exclusion criteria: Men cannot participate, nor can individuals under 18 or over 65 years of age, pregnant or breastfeeding women, those with severe kidney disease, active infections, severe liver problems, blood clotting disorders, or anyone who participated in another clinical trial within the past 30 days.

Trial focus: The study will measure bone density using DXA scans, blood sugar levels through various methods including fasting glucose and glucose tolerance tests, and track changes in muscle mass and strength. Throughout the study, participants will receive either 60 mg of denosumab or saline solution injections under the skin.

Investigational drug: Denosumab is a medication that blocks a protein involved in bone loss. It works by inhibiting RANK ligand, which is essential for bone-dissolving cells. Researchers are studying how this medication might affect muscle strength and insulin sensitivity in addition to its bone health benefits.

Study of Metformin Treatment to Maintain Type 2 Diabetes Remission in Patients After Bariatric Surgery

This study examines whether metformin can help maintain diabetes remission in patients who have achieved improvement or complete resolution of Type 2 diabetes following bariatric surgery. The research compares metformin treatment with standard care over three years.

Main inclusion criteria: Participants must be between 18 and 70 years old and have undergone bariatric surgery (gastric bypass or sleeve gastrectomy) 12 to 36 months before joining. They must have previously had Type 2 diabetes (either used at least one diabetes medication before surgery or had an HbA1c of 6.5% or higher), currently have an HbA1c below 6.5%, and must not have taken diabetes medications in the past 3 months.

Main exclusion criteria: People outside the specified age range, those with active Type 2 diabetes without remission after surgery, pregnant women or those planning pregnancy, people with known allergies to metformin, severe kidney or liver problems, history of lactic acidosis, current participation in other trials, or any condition that could interfere with study participation cannot join.

Trial focus: The study will monitor participants through regular blood tests measuring blood sugar levels, nutritional status, weight and body mass index tracking, quality of life questionnaires, and stool sample collection to analyze gut bacteria. One group will receive metformin with a maximum daily dose of 1700 mg, while the other will receive standard care without metformin.

Investigational drug: Metformin is a commonly prescribed diabetes medication that helps control blood sugar levels by improving how the body responds to insulin and reducing sugar production by the liver. The study aims to determine if it can help extend diabetes remission after weight loss surgery.

Study on Dulaglutide for Preventing Diabetes in New Kidney Transplant Patients

This clinical trial investigates whether using dulaglutide (Trulicity), a GLP-1 receptor agonist, immediately after kidney transplant can prevent the development of diabetes in people who are at high risk. The study follows participants for up to 12 months.

Main inclusion criteria: Participants must be new kidney transplant recipients older than 18 years with no history of diabetes (HbA1c of 6.5% or lower before transplant). They must be taking tacrolimus and prednisone as maintenance treatment and have a high risk of developing diabetes, determined by having at least two of these factors: being older than 50, BMI of 30 or higher, close family member with diabetes, high triglycerides greater than 2.82 mmol/L, or having prediabetes.

Main exclusion criteria: Patients not in the 18 to 64 age range, not considered high-risk for developing diabetes after kidney transplant, not in the immediate period following transplant, already diagnosed with diabetes before transplant, or part of a vulnerable population cannot participate.

Trial focus: The research will assess the proportion of patients developing prediabetes and diabetes at 3 and 12 months post-transplant through fasting glucose levels and oral glucose tolerance tests. Additional evaluations include monitoring the number and type of medications needed for diabetes control, insulin sensitivity, weight changes, kidney function, and lipid profile.

Investigational drug: GLP-1 receptor agonists help the body produce more insulin when needed, reduce sugar production by the liver, and slow down digestion to help control blood sugar levels. The specific medication used in this study is dulaglutide (Trulicity), administered as an injectable solution.

Study on the Effect of Raxtozinameran Vaccine in Reducing Type 1 Diabetes Risk in Children with High Genetic Susceptibility

This clinical trial examines whether vaccinating children with high genetic risk for Type 1 diabetes against COVID-19 from the age of 6 months can reduce the chances of developing islet autoantibodies or Type 1 diabetes itself during childhood. The study will continue until 2029.

Main inclusion criteria: Children must be between 3 and 4 months old at the time of joining and have a high genetic risk (more than 10%) of developing islet autoantibodies by age 6. This risk is determined by specific genetic markers (HLA DR/DQ genotype), a polygenic risk score, and having a close family member with Type 1 diabetes. Written informed consent must be signed by the child’s parent or guardian.

Main exclusion criteria: The trial data does not specify detailed exclusion criteria beyond the requirement that participants must meet the inclusion criteria.

Trial focus: The main goal is to measure the time it takes for islet autoantibodies or Type 1 diabetes to develop after children are randomly assigned to receive either the Comirnaty Omicron XBB.1.5 COVID-19 mRNA vaccine or a 0.9% saline solution. The vaccine is given as an injection at a dose of 3 micrograms, and children will have regular follow-up visits to monitor their health and development.

Investigational drug: The COVID-19 mRNA vaccine being studied uses a small piece of genetic material to help the body recognize and fight the virus that causes COVID-19. Researchers are investigating whether this vaccination might also help prevent the immune system from attacking insulin-producing cells in the pancreas.

Study on the Effect of Semaglutide in Patients with Type 1 Diabetes and Insulin Resistance

This clinical trial studies the effects of semaglutide (Ozempic) in patients with Type 1 diabetes who also have characteristics of Type 2 diabetes, a situation sometimes called “double diabetes.” The study aims to see how adding semaglutide to standard insulin treatment affects blood sugar control over six months.

Main inclusion criteria: Participants must be over 18 years old with Type 1 diabetes confirmed by low C-peptide levels, diagnosed before age 35, and treated with optimized insulin therapy for at least 1 year. They must have a BMI of 27 kg/m² or higher, an HbA1c level between 7.5% and less than 12%, and meet at least one additional criterion such as family history of Type 2 diabetes or obesity, triglycerides greater than 1.50 g/l, or low HDL cholesterol levels. Participants must also use continuous glucose monitoring.

Main exclusion criteria: People without Type 1 diabetes with “double diabetes” characteristics, those outside the specified age range, pregnant women or those planning pregnancy, and individuals unable or unwilling to follow study procedures cannot participate.

Trial focus: The study will measure the percentage of time blood sugar levels stay within the target range (0.70-1.80 g/l) using continuous glucose monitoring. Researchers will also track changes in HbA1c levels, body weight, waist circumference, and daily insulin dose. Women of childbearing age must use effective contraception throughout the study and for up to 2 months after treatment ends.

Investigational drug: Semaglutide is administered as a weekly subcutaneous injection. It works by mimicking a natural hormone called GLP-1, which helps regulate insulin secretion and reduce blood sugar levels. The available dosages in the study are 0.25 mg, 0.5 mg, and 1 mg.

Study on the Effects of Alendronate on Bone and Blood Sugar Markers in Patients with Diabetes and Osteopenia/Osteoporosis

This clinical trial investigates how alendronate affects markers related to bone health and blood sugar control in patients with either Type 1 or Type 2 diabetes who also have osteopenia or osteoporosis. The study will last up to 24 months.

Main inclusion criteria: Participants must have Type 1 or Type 2 diabetes, be 50 years old or older, and have been on the same diabetes treatment for the last six months (although dose changes are allowed). They must have an HbA1c level of 6.7% or higher in the last six months, a BMI between 19 and 35, and a DXA T-score (bone density measurement) between -3.5 and -0.5. Both men and women can participate.

Main exclusion criteria: Pregnant or breastfeeding women, individuals with severe kidney problems, people with a history of allergic reactions to the study medication, those who have taken similar medications recently, people with certain other medical conditions that might interfere with the study, and those unable to follow study procedures cannot participate.

Trial focus: The study will monitor various health markers including HbA1c levels, bone mineral density using DXA scans, insulin levels, plasma glucose, and other biochemical markers related to bone and metabolic health. Lifestyle factors such as diet and physical activity will also be assessed. Participants will receive either Alendronate Teva 70 mg tablets or a placebo once a week.

Investigational drug: Alendronate is a bisphosphonate medication that works by inhibiting the cells that break down bone, helping to maintain or increase bone density. In this trial, researchers are examining how it might influence blood sugar control in addition to its bone health benefits.

Study on the Effects of Empagliflozin, Pioglitazone, and Semaglutide for Patients with Type 2 Diabetes

This clinical trial compares the effects of three different medications for Type 2 diabetes: empagliflozin (Jardiance), pioglitazone (Actos), and semaglutide (Rybelsus). The study will explore how these medications differ in their positive effects on fat tissue function over six months.

Main inclusion criteria: Participants must provide written consent and be between 30 and 70 years old with a BMI of 25 or higher and an HbA1c level of 42 mmol/mol or higher. Fertile women must use effective contraception throughout the study, including methods like combined hormonal contraceptives, progestogen-only contraceptives, intrauterine devices, bilateral tubal occlusion, having a partner who has had a vasectomy, or practicing sexual abstinence. Women of childbearing potential need a negative pregnancy test before starting.

Main exclusion criteria: Individuals without Type 2 diabetes and people considered part of a vulnerable population who might not be able to give informed consent cannot participate.

Trial focus: The study will measure lipolysis (the breakdown of fats) in isolated fat cells from the abdominal area and examine cellular differences in fat tissue using specific genetic tests. Participants will be randomly assigned to receive either Rybelsus (semaglutide) in doses of 3 mg, 7 mg, or 14 mg, Actos (pioglitazone) in doses of 15 mg, 30 mg, or 45 mg, or Jardiance (empagliflozin) in doses of 10 mg or 25 mg. All medications are taken orally in tablet form daily.

Investigational drugs: Empagliflozin works by helping the kidneys remove glucose through urine. Pioglitazone improves the body’s sensitivity to insulin. Semaglutide mimics a hormone that increases insulin release and helps with weight loss. The study aims to compare how these three medications affect fat tissue function in people with Type 2 diabetes.

Study on the Safety and Effectiveness of VX-880 for Patients with Type 1 Diabetes and Severe Low Blood Sugar Awareness

This clinical trial tests a new treatment called VX-880 solution for infusion, a type of cell therapy designed to help people with Type 1 diabetes who have difficulty recognizing low blood sugar levels and experience severe low blood sugar episodes.

Main inclusion criteria: Participants must have clinical history and laboratory evidence of Type 1 diabetes, experienced at least 2 episodes of severe hypoglycemia in the past 12 months, have reduced awareness of hypoglycemia, and use a continuous glucose monitor consistently for at least 3 months before the study starts (unless CGM is not commonly used in their area). They must have a compatible blood group (type A or AB) and be within the specified age range.

Main exclusion criteria: People with medical conditions other than Type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia, those outside the specified age range, people not included in the study’s target groups, or those belonging to vulnerable populations that need special protection cannot participate.

Trial focus: The study will monitor participants for safety and tolerability, focusing on treatment-emergent adverse events, clinical laboratory values, vital signs, and imaging findings. The primary goal is to assess the proportion of participants who achieve insulin independence by Day 365 after the infusion. Secondary outcomes include freedom from severe hypoglycemic events from Day 90 to Day 365, changes in HbA1c levels, reduction in insulin dose, and maintenance of insulin independence.

Investigational drug: VX-880 is administered through intraportal infusion and involves a total of 0.8 × 10E9 SC-islet cells given once. The treatment is being studied to see if it can potentially restore insulin production and help patients achieve better blood sugar control.

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

This clinical trial focuses on treating Type 1 diabetes using a new gene therapy approach called IMMUNOSTEM. The treatment uses the patient’s own blood-forming stem cells that are modified in a laboratory using a lentiviral vector to introduce a gene that produces human programmed death-ligand 1 protein.

Main inclusion criteria: Participants must be able to understand and sign an informed consent form, be between 18 and 40 years old, and able to follow all study procedures. They must have been recently diagnosed with Type 1 diabetes (within 180 days of starting insulin treatment), have an HbA1c between 53 and 150 mmol/mol, test positive for at least 2 autoantibodies, and have C-peptide levels of at least 0.2 nmol/L or 0.6 ng/mL (either at rest or during a special meal test).

Main exclusion criteria: People without a Type 1 diabetes diagnosis, children under 18, pregnant or breastfeeding women, those with severe allergic reactions in the past, participation in other trials within 30 days, serious medical conditions that could interfere with the study, uncontrolled blood sugar levels, severe diabetes complications, or inability to commit to regular study visits cannot participate.

Trial focus: The main purpose is to evaluate if this new treatment is safe for patients recently diagnosed with Type 1 diabetes who still have some functioning insulin-producing cells. The modified cells are given as a single intravenous injection. Regular monitoring includes blood tests, blood sugar level checks, mixed meal tolerance tests, and continuous blood sugar monitoring over 24 months. The total study duration is from August 2025 to August 2029.

Investigational drugs: The treatment uses autologous hematopoietic stem and progenitor cells modified using a lentiviral vector to express PD-L1. This is a cell therapy using the patient’s own modified cells rather than a traditional medication. The modification is done in a laboratory before the cells are returned to the patient’s body through intravenous infusion.

A Study of Long-Term Safety of Teplizumab in Children and Adolescents with Recently Diagnosed Type 1 Diabetes

This study evaluates the long-term safety of teplizumab, a humanized antibody medication, in children and adolescents with recently diagnosed Type 1 diabetes who previously participated in an earlier study. The current study will monitor these patients for an additional 42 months.

Main inclusion criteria: Participants must have completed the PRV-031-001 (PROTECT) study through Week 78 visit, regardless of how many doses they received. Written informed consent must be provided within 12 months after completing Week 78 of the previous study. For participants under 18, written assent must be obtained according to applicable regulations. Both male and female participants can join, and they must be either adolescents (12-17 years old) or adults (18 years and older).

Main exclusion criteria: Current pregnancy or plans to become pregnant, presence of serious medical conditions that could interfere with study procedures, not completing the previous PROTECT study, known allergic reactions to teplizumab or similar medications, active infections or major illnesses, use of other experimental drugs within the past 30 days, significant kidney or liver problems, history of severe allergic reactions, inability to follow study procedures, or mental conditions affecting informed consent cannot participate.

Trial focus: Throughout the extension study, participants will receive teplizumab through intravenous infusion. The medical team will closely monitor health for any side effects, track adverse events, conduct mixed-meal tolerance tests to measure insulin production, record daily insulin use, and take regular measurements of HbA1c levels. The study is expected to continue until October 2026.

Investigational drug: Teplizumab (PRV-031) is a humanized monoclonal antibody that targets the CD3 receptor on T cells. It works by modifying the immune system’s response, potentially preserving the body’s ability to produce insulin by preventing the immune system from attacking insulin-producing cells in the pancreas.

The following trials are also part of this research portfolio, bringing the total to 14 studies. Brief information about these additional trials is available in the source data, but detailed descriptions are limited to the first 10 trials as described above.

Summary

The current landscape of clinical trials for diabetes mellitus shows a diverse range of therapeutic approaches being investigated across Europe. With 14 ongoing trials, the research spans from prevention strategies in genetically at-risk children to novel treatments for both Type 1 and Type 2 diabetes, as well as management of complications like Charcot foot and post-transplant diabetes.

A notable concentration of trials appears in Western and Northern European countries, particularly in Germany, France, and the Netherlands, each hosting multiple studies. Scandinavia is well represented with trials in Denmark and Sweden, while Southern Europe has representation through Spain and Italy. Central Europe participates through Poland, Belgium, Czechia, and Austria, with Norway also contributing to the research efforts.

The investigational approaches show significant diversity. Several trials focus on immunomodulatory therapies, including teplizumab for recently diagnosed Type 1 diabetes children and a COVID-19 vaccine trial exploring potential prevention of Type 1 diabetes in genetically susceptible children. Cell-based therapies are represented by VX-880 and VX-264 implants, as well as the IMMUNOSTEM gene therapy using modified stem cells.

For Type 2 diabetes, multiple trials examine GLP-1 receptor agonists (semaglutide, dulaglutide) and SGLT2 inhibitors (empagliflozin), reflecting current trends in diabetes pharmacotherapy. Metformin, a well-established medication, is being studied for maintaining diabetes remission after bariatric surgery. Several trials also address bone health concerns in diabetic patients, investigating denosumab and alendronate.

The trials employ various innovative monitoring approaches, including continuous glucose monitoring systems, which are featured in multiple studies to provide detailed blood sugar tracking. Treatment durations range from 6 months to 5 years, with some extension studies monitoring long-term safety for up to 42 additional months.

These research efforts represent a comprehensive approach to diabetes management, addressing prevention, treatment of newly diagnosed cases, management of established disease, and prevention of complications. The geographic distribution and variety of therapeutic approaches suggest a robust and collaborative European research environment in diabetes care.

Ongoing Clinical Trials on Diabetes mellitus

  • Study on the Safety and Effects of VX-264 for Patients with Type 1 Diabetes

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy The Netherlands

  • Study on Switching to Insulin Glargine 300 U/ml from Insulin Glargine 100 U/ml for Patients with Type 2 Diabetes and Kidney Problems

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Spain

  • Study of Metformin Treatment to Maintain Type 2 Diabetes Remission in Patients After Bariatric Surgery

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Denosumab for Healing Bone Fractures in Diabetic Patients with Charcot Foot

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effectiveness of Oxygen Therapy for Patients with Diabetic Foot Ulcers

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands Spain

  • Study on the Effects of Alendronate on Bone and Blood Sugar Markers in Patients with Diabetes and Osteopenia/Osteoporosis

    Not recruiting

    3 1 1
    Investigated diseases:
    Denmark

  • A Study of Long-Term Safety of Teplizumab in Children and Adolescents with Recently Diagnosed Type 1 Diabetes

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Poland

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