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TOL-3021 for Type 1 Diabetes (SUNRISE Trial)
SUNRISE Trial Summary
This trial will test if a new drug is safe and effective for people with type 1 diabetes.
- Type 1 Diabetes
SUNRISE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SUNRISE Trial Design
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Who is running the clinical trial?
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- You are currently using biotin or supplements that contain biotin.You have a specific type of diabetes known as MODY (Monogenic diabetes).You are currently taking verapamil or α-methyldopa medications.You are taking more than 4,000 mg of acetaminophen per day.You have a type of diabetes called LADA and have been treated with medications used for type 2 diabetes for more than 30 days.Your adrenal glands do not produce enough hormones and your treatment for this condition is not effective or stable.You have asthma that requires taking pills for treatment. Using an inhaler is allowed.
- Group 1: TOL-3021 Placebo
- Group 2: TOL-3021
- 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
What are the criteria for inclusion in this research study?
"Qualified candidates with diabetes and autoimmune conditions between the ages of 12 to 40 are welcomed to join this medical trial. The maximum number of participants is set at 78 people."
Are there opportunities for participants to join this investigation?
"According to clinicaltrials.gov, this trial has ended its recruitment period and is no longer actively seeking out patients; the first posting was on June 17th 2019 while the most recent update occurred November 5th 2020. However, there are over 1200 other studies currently looking for volunteers."
Is there an upper age limit for participants in this experiment?
"This clinical trial seeks out participants aged 12 to 40 years old. In comparison, 217 trials are available for minors and 916 studies accommodate those above the age of 65."
How many venues are administering this experiment?
"At the moment, 23 medical sites are recruiting for this clinical trial. These locations contain San Francisco, San Diego, and Charlottesville alongside many other cities. When selecting a clinic to participate in the study at, it is crucial that you pick one closest to your home so as to limit travel demands."
Has regulatory approval been granted for TOL-3021?
"Although there is evidence for the safety of TOL-3021, as this trial is Phase 2, no data has yet demonstrated its efficacy - thus it earned a score of 2."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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