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Immunomodulator
TOL-3021 for Type 1 Diabetes (SUNRISE Trial)
Phase 2
Waitlist Available
Research Sponsored by Tolerion, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36, 52 weeks
Summary
This trial tests TOL-3021, a muscle injection, in people aged 12 to under 41 who have had Type 1 Diabetes for less than 5 years. The goal is to see if it helps control their blood sugar levels better.
Eligible Conditions
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12, 24, 36, 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, 36, 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Events of Special Interest
Immunologic - Quantum dot (Q-dot) responses
Antibodies
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TOL-3021Experimental Treatment1 Intervention
TOL-3021 2 mg/mL
Group II: TOL-3021 PlaceboPlacebo Group1 Intervention
TOL-3021 Placebo
Find a Location
Who is running the clinical trial?
Tolerion, Inc.Lead Sponsor
2 Previous Clinical Trials
Alexander Fleming, M.D.Study DirectorTolerion, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: TOL-3021 Placebo
- Group 2: TOL-3021
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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