Clinical Trials for Insulin-Requiring Type 2 Diabetes Mellitus
There are currently 2 ongoing clinical trials exploring different approaches to managing insulin-requiring type 2 diabetes mellitus and related conditions. These studies are being conducted across several European countries and involve research into both preventive strategies for type 1 diabetes in at-risk children and new approaches to conducting clinical trials for adults with type 2 diabetes requiring insulin treatment.
Clinical trial locations
- Austria
- Belgium
- Denmark
- Germany
- Italy
- Poland
- Spain
- Sweden
Study on the Effect of Raxtozinameran Vaccine in Reducing Type 1 Diabetes Risk in Children with High Genetic Susceptibility
This study is investigating whether early COVID-19 vaccination might help reduce the risk of type 1 diabetes in children who have a high genetic risk of developing the condition. The research focuses on young children aged 3 to 4 months at enrollment and follows them through childhood to see if vaccination affects their chances of developing markers of diabetes.
Who can participate:
- Children between 3 and 4 months old
- Children with a high genetic risk (more than 10%) of developing islet autoantibodies by age 6, determined by specific genetic markers and family history
- Written informed consent must be provided by the child’s parent or guardian
Main focus: The trial aims to determine whether vaccinating young children with the Comirnaty Omicron XBB.1.5 COVID-19 mRNA vaccine can reduce the development of islet autoantibodies or type 1 diabetes during childhood. Islet autoantibodies are markers that indicate the immune system is attacking the insulin-producing cells in the pancreas. The study will follow children until 2029 to measure the time it takes for these conditions to develop and to assess whether the vaccine provides protective benefits against type 1 diabetes.
Investigational drug: The study uses the Comirnaty Omicron XBB.1.5 COVID-19 mRNA Vaccine, administered as an injection at a dosage of 3 micrograms per dose. This vaccine helps the body recognize and fight the COVID-19 virus and is being studied for its potential to prevent infections that could trigger autoimmune responses leading to diabetes. Some participants will receive the vaccine while others will receive a simple saline solution as a placebo for comparison.
Study on Insulin Glargine for Patients with Type 2 Diabetes: Comparing Decentralized, Hybrid, and Standard Clinical Trial Approaches
This innovative study examines different ways of conducting clinical trials while studying the effectiveness of insulin glargine treatment. Rather than focusing solely on medication effects, it explores whether using technology-based approaches such as remote data entry, video conferencing, and home visits can improve patient experience and trial outcomes compared to traditional hospital-based trials.
Who can participate:
- Adults diagnosed with type 2 diabetes mellitus for at least one year
- Currently treated with basal insulin for at least three months, with a stable daily dose for the past month
- Able to perform daily activities including self-administering insulin injections and checking blood sugar levels
- Willing to allow home visits (for Part A participants)
- Access to a tablet or smartphone with Bluetooth and internet connection
- Signed written consent or e-consent depending on study group assignment
Who cannot participate:
- Patients with other serious medical conditions that could interfere with the study
- Pregnant or breastfeeding women
- Those who participated in another clinical trial within the last 30 days
- History of allergic reactions to the study medication
- History of drug or alcohol abuse
- Uncontrolled high blood pressure
- Severe kidney or liver disease
- History of heart disease or stroke
- Currently taking medications that could interfere with the study
Main focus: The 24-week study compares decentralized, hybrid, and standard clinical trial approaches to evaluate which method is more effective in terms of participant recruitment speed, completion rates, participant diversity, treatment adherence, and data quality. The trial also measures changes in blood sugar control by monitoring HbA1c levels and fasting blood sugar. Additionally, it assesses participant and site satisfaction with different trial formats and evaluates cost-effectiveness of technology-centered approaches.
Investigational drug: Participants use Toujeo (insulin glargine 300 units/ml), a long-acting insulin delivered through a pre-filled pen device called SoloStar. This medication provides a steady amount of insulin throughout the day via subcutaneous injection, helping to maintain stable blood sugar levels. Toujeo works by mimicking natural insulin, allowing cells to absorb glucose from the blood and thereby lowering blood sugar levels.
Summary
The two ongoing clinical trials represent distinct approaches to diabetes research across multiple European countries. The first study takes a preventive approach, investigating whether early vaccination might reduce type 1 diabetes risk in genetically susceptible children, with research sites in Poland, Germany, Austria, Sweden, and Belgium. The second trial focuses on adults already requiring insulin treatment and explores innovative ways to conduct clinical research using technology and remote monitoring across Poland, Spain, Denmark, Italy, and Germany.
Both studies are being conducted in multiple European countries, with Germany and Poland hosting both trials. The research reflects a broader trend in diabetes care toward both prevention strategies in high-risk populations and improved clinical trial methodologies that may make participation more convenient for patients. The use of different insulin formulations and innovative research approaches demonstrates ongoing efforts to improve diabetes management and expand our understanding of these complex conditions.
