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MAS-1 Adjuvanted Immunotherapy for Type 1 Diabetes (MER3101 Trial)
MER3101 Trial Summary
This trial is testing if a new drug is safe and effective at treating type 1 diabetes.
MER3101 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MER3101 Trial Design
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Who is running the clinical trial?
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- I agree not to get routine vaccines for the first 100 days after starting the study drug, except for the COVID-19 vaccine after 60 days.I am not pregnant and agree to prevent pregnancy during and up to 2 months after treatment.I have had cancer before.I have serious diabetes complications like kidney issues or eye problems.It has been over a month since my last vaccination.I am taking medication that affects my blood sugar levels.I have chronic kidney disease with a creatinine level over 1.5mg/dL.I have a history of neuropathy, foot ulcers, amputations, or kidney disease.I am a man who can father children and agree to use birth control during and for 2 months after treatment.My C-peptide levels were at least 0.2 pmol/ml during a test after eating, measured between 21 days and one month after my diabetes diagnosis.It has been over 30 days since my last COVID-19 vaccine dose.You have had allergic reactions to squalane or other parts of the study vaccine.I am currently diagnosed with COVID-19.You currently have or have had HIV, Hepatitis B, or Hepatitis C.I have untreated proliferative diabetic retinopathy.I am 18-45 years old, have type 1 diabetes, and tested positive for an islet cell autoantibody.I was diagnosed with Type 1 diabetes in the last 2 years.I have an active infection or a positive test for tuberculosis.I do not have any health issues that could make the study risky for me.Your HbA1c levels must be below 9.5 to join the study.I am taking medication (not insulin) to control my blood sugar.I need to take medication that weakens my immune system.
- Group 1: TBD ug IBC in 0.25 mL MAS-1 emulsion
- Group 2: 33 ug IBC in 0.25 mL MAS-1 emulsion
- Group 3: 109 ug IBC in 0.25 mL MAS-1 emulsion
- Group 4: 327 ug IBC in 0.25 mL MAS-1 emulsion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age range for participants in this study inclusive of those above 35 years?
"According to the study's inclusions criteria, only those aged between 18 and 45 can participate. However, there are 228 trials for minors and 970 clinical studies catered toward seniors."
Are there precedents for this treatment in the existing scientific literature?
"Currently, 71 investigations into this particular intervention are taking place. 13 of these experiments have reached the third and final phase of research. While Cincinnati is home to most trials exploring this treatment, 247 different medical centers across the United States are involved in its development."
Are the potential risks of this therapy acceptable for patients?
"This therapy has only been tested on a limited basis, so it was awarded an initial safety rating of 1."
Is there an ongoing recruitment of participants for this experiment?
"According to the public record on clinicaltrials.gov, this clinical trial is in an active recruitment phase and was initially listed at the end of August 2020 with its most recent update being published in May 2022."
May I participate in this experiment?
"This medical trial is currently seeking 28 participants aged 18 to 45 with newly diagnosed diabetes mellitus. Additionally, the following criteria must be met: females of reproductive age require a negative pregnancy test and are obligated to abstain from conception until two months after study drug administration, ADA-approved T1DM diagnosis within the past 2 years, C-peptide levels ≥ 0.2 pmol/ml during an MMTT conducted 21 days post-diagnosis and before randomization, one month minimum since last immunization prior to enrolment in the clinical trial, intensive diabetes management compliant behaviour expected throughout duration of treatment; routine vaccinations prohibited for"
How many participants are enrolled in this research program?
"Affirmative. Information hosted on clinicaltrials.gov indicates that this experiment, initially posted in August of 2020, is searching for 28 volunteers from 1 site to participate. The most recent update was May 4th 2022."
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