Diabetes Mellitus, Type 1Phase 2SUNRISENCT03895437
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
A Phase 2 study testing TOL-3021 in people with Diabetes Mellitus, Type 1, run by Tolerion, Inc. at 23 sites in United States.
Trial summary
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- TOL-3021
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 23 sitesUnited States
- Study dates
- 17 Jun 2019to 21 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association (ADA) criteria and within 5.0 years from diagnosis, defined as the first day of insulin administration.
- Age at randomization of 12.0 - <41.0 years of age .
- Adequate glycemic control as defined by HbA1c ≤7.9% based on point-of-care or local lab measurement and time in glycemic range (70-180 mg/dL) >55% by CGM recording over 3 or more consecutive or non-consecutive days within 5 days prior to baseline mixed meal tolerance test (MMTT).
- On insulin therapy (total insulin dose >0.125 U/kg body weight)
- Presence of antibodies to at least one of the following antigens: glutamic acid decarboxylase (GAD65), islet antigen 2 (IA-2), zinc transporter 8 (ZnT8), or insulin if obtained within 10 days of the onset of exogenous insulin therapy, or documentation of positive antibodies. In the absence of a positive result for one of the specified antibodies, diagnosis of T1D as per the ADA guidelines..
- Peak C-peptide during screening 4-hour mixed meal tolerance test (MMTT) ≥ 0.150 nmol/L.
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- Willingness to wear the Dexcom G6 continuous glucose monitoring (CGM) device and use according to instructions including recording of total daily insulin dose taken most of each day from screening to end of treatment period.
- Written informed consent and, for subjects aged 12-<18 years of age, patient assent and parental or guardian consent, including authorization to release health information.
- Willingness and ability of subject to comply with all study procedures of the study protocol, including attending all clinic visits.
Who cannot join
- Receiving a dose of acetaminophen >4,000 mg per day.
- Body Mass Index (BMI) >32 kg/m² for patients 18 and older (>85th percentile for ages 12-17)
- Previous immunotherapy for T1D within 2 years of enrollment.
- Diagnosis of liver disease or hepatic enzymes, as defined by alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of normal (ULN).
- Hematology: white blood cells (WBC) <3 x 10⁹/L; platelets <100 x 10⁹/L; hemoglobin <10.0 g/dL. (Low WBC values may be repeated every 3-7 days, and results to be discussed with the Medical Monitor.) Any underlying conditions likely to impact red blood cell turnover.
- Latent autoimmune diabetes of adults (LADA), which is generally associated with preceding history and treatment of T2D with medications typically used for treatment of type 2 diabetes (T2D) for more than 30 days.
Show all 31Show fewer
- Monogenic diabetes (MODY).
- Estimated glomerular filtration rate (eGFR) <60 ml/min for ages 18-<41, and <75 ml/min per 1.73 m² for ages 12-<18.
- History of malignancy, except for cancers in remission >5 years, or basal cell or in situ squamous cell carcinoma of the skin.
- Significant cardiovascular disease (including inadequately controlled hypertension), history of myocardial infarction, unstable angina, use of anti-anginal medicines (e.g., nitroglycerin), or abnormal stress test, which, in the opinion of the Principal Investigator (PI), would interfere with participation in the trial.
- Immunosuppressive therapy (systemic corticosteroids, cyclosporine, azathioprine, or biologics) within 30 days of screening.
- Current or prior (within the last 30 days) use of metformin, sulfonylureas, glinides, thiazolidinediones, GLP1-RAs, DPP-IV inhibitors, pramlintide, or SGLT-2 inhibitors.
- Current use of verapamil or α-methyldopa.
- History of any organ transplant, including islet cell transplant.
- Asthma that requires oral glucocorticoid therapy. Inhaled glucocorticoid therapy is permitted.
- Active autoimmune or immune deficiency disorder including rheumatoid arthritis, moderate-to-severe psoriasis, inflammatory bowel disease, and other autoimmune conditions that may require treatment with tissue necrosis factor (TNF) or other biologics. Permitted autoimmune disorders include T1D or well-controlled autoimmune conditions (e.g., thyroid disease, celiac disease, and sarcoidosis, all with stable non-immunosuppressive medications for the past 30 days).
- Thyroid-stimulating hormone (TSH) at screening >7.5 mIU/L for ages 18-<41 years old and > 3.6mIU/L for ages 12-<18 years old. .
- Adrenal insufficiency not adequately controlled with stable replacement glucocorticoid therapy.
- Moderate non-proliferative retinopathy (NPDR) or proliferative retinopathy
- Evidence of infection with hepatitis B virus (HBV), as defined by hepatitis B surface antigen( HBsAg), HCV (anti-HCV antibodies), or human immunodeficiency virus (HIV).
- Subject is breastfeeding.
- Positive urine pregnancy test at screening or at any time during the study (pregnancy tests must be performed as per the visit schedule). Females of childbearing potential must be excluded if they have a positive urine pregnancy test at screening or randomization or if they are not using medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, IUD, progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or 1 year or more postmenopausal must be specified in the subject's Case Report Form (CRF).
- Males of reproductive potential who are unwilling to use medically acceptable birth control, unless the female partner is postmenopausal or surgically sterile.
- Any social condition or medical condition that would, in the opinion of the principal investigator (PI), prevent complete participation in the study or would pose a significant hazard to the subject's participation.
- Anticipated major surgery during the duration of the trial, which could interfere with participation in the trial.
- History of drug or alcohol dependence within 12 months of screening.
- Psychiatric disorder that would prevent subjects from giving informed consent.
- Household members of current participants in this protocol.
- Subjects who are not fluent in the English language.
- Participation in other studies involving the administration of an investigational drug or experimental device, including the administration of an experimental agent for T1D within 30 days of screening, or use of an experimental therapeutic device for T1D within 30 days prior to screening. Subjects previously treated with diagnostic devices are not excluded.
- Any current use of biotin or biotin containing supplements
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
Emory University
Atlanta, Georgia, 30322
MedStar Health Research Institute
Baltimore, Maryland, 21239
Joslin Diabetes Center- Adult & Pediatric
Boston, Massachusetts, 02215
University of North Carolina Diabetes Care Center
Chapel Hill, North Carolina, 27517
University of Virginia
Charlottesville, Virginia, 22903
Barbara Davis Center - University of Colorado Denver
Denver, Colorado, 80045
University of Florida
Gainesville, Florida, 32610
MedStar Health Research Institute
Hyattsville, Maryland, 20782
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
University of Iowa
Iowa City, Iowa, 52242
Baptist Health Research Institute
Jacksonville, Florida, 32258
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Miami Diabetes Research Institute
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06520
Naomi Berrie Diabetes Center, Columbia University
New York, New York, 10032
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Altman Clinical and Translational Research Institute UCSD
San Diego, California, 92093
University of California San Francisco
San Francisco, California, 94143
Mills-Peninsula Medical Center
San Mateo, California, 94401
Stanford University
Stanford, California, 94305
SUNY Upstate Medical University
Syracuse, New York, 13210
University of South Florida Diabetes Center
Tampa, Florida, 33612
About this study
Official title: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of TOL-3021 in Patients With New Onset or Established Type 1 Diabetes Mellitus
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up.
Read the detailed description
The SUNRISE study is a prospective, multi-center, double-blind, randomized, placebo-controlled trial in subjects aged 12.0 to <41.0 years diagnosed with type 1 diabetes (T1D), as defined by American Diabetes Association (ADA) criteria, and within 5 years of diagnosis. Time of diagnosis is defined as the first day of insulin administration. Subjects will be stratified by duration (zero up to 1 year and 1 year up to five years) to ensure balance of disease duration across treatment and placebo groups in each strata. For analytical purposes, all subjects12-<41 will be considered cohort A, subjects aged 12-<18 will considered cohort B and subjects aged 18-<41 will be considered cohort C. For subjects aged 12-<18 (Cohort B), dosing will be staggered with an initial 6 subjects aged 14-<18 being enrolled with the last subject a having a minimum of 2 injections with at least 1 week follow-up after the 2nd injection. Safety data from this cohort will be evaluated before opening the study to subjects 12 and older. Subjects should be randomized no sooner than 6 weeks after diagnosis, unless glycemic range is adequately controlled as confirmed by time in glycemic range (70-180 mg/dL) >55% by continuous glucose monitoring (CGM) recording over 3 or more consecutive or non-consecutive days. Screening assessments will include a physical examination, a fundoscopic photograph, chemistry and hematology safety labs, urinalysis, 24-hour urine protein and creatinine, hemoglobin A1c (HbA1c), presence of T1D antibodies, and a 4-hour mixed meal tolerance test (MMTT). Approximately 99 qualified subjects who meet all selection criteria will be randomized in a 2:1 ratio to treatment with TOL-3021 or placebo and treated for 52 weeks. Study drug treatments will be administered via an intramuscular (IM) injection into a large muscle every week for 52 weeks. CGM will be initiated within 5 days prior to the screening MMTT visit and continued through Week 52. Subjects will agree to diabetes management during the study with the goal of maintaining HbA1c levels of approximately 7.0% without frequent episodes of hypoglycemia.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- TOL-3021, TOL-3021 Placebo
- Keywords
- Type 1 Diabetes, Diabetes, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOL-3021Biological
TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
TOL-3021 PlaceboOther
Also called Placebo
TOL-3021 Placebo
| Study group | Role | What they receive |
|---|---|---|
| TOL-3021 | Experimental | TOL-3021 2 mg/mL Receives: Biological: TOL-3021 |
| TOL-3021 Placebo | Placebo comparator | TOL-3021 Placebo Receives: Other: TOL-3021 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on Log-transformed Mixed Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
The primary outcome is the TOL-3021 treatment effect as determined by a repeated measures analysis of change from baseline in the log-transformed MMTT C-peptide AUC at 12, 16, and 24 weeks
Measured: Baseline,12,16 and 24 weeks
Secondary outcomes (9)
Hypoglycemia - % Time Continuous Glucose Monitor (CGM) Reading < 54 mg/dL
Rates of clinically important hypoglycemia events as defined by total measured glucose value of <54 mg/dL (3.0 mM/L) over each approximately 12-week period ending at Week 24.
Measured: Baseline, Weeks 1-12, Weeks 13-24
Hypoglycemia -Time CGM < 70 mg/dL
% Time that CGM measured glucose <70 mg/dL during each time interval
Measured: Baseline, Weeks 1-12, Weeks 13-24
Severe Hypoglycemic Events Lasting at Least 15 Minutes
Number of hypoglycemic events during interval that CGM < 54 mg/dL for at least 15 consecutive minutes
Measured: Baseline, Weeks 1-12, Weeks 13-24
Treatment Effect on Daily Insulin Requirements
Change from baseline in mean number of insulin units administered each day
Measured: Baseline, Weeks 1-12 and Weeks 13-24
Effect on Hemoglobin A1c (HbA1c)
Change from baseline in Hemoglobin A1c
Measured: Baseline, 12, 16, 24 weeks
Number of Participants With Adverse Events (AEs)
Summary of AEs by MedDRA System Organ Class (SOC) and Preferred Term
Measured: Baseline to 24 Weeks
Summary of Treatment Emergent Adverse Events (TEAEs)
Summary of Related Adverse Events by MedDRA System Organ Class (SOC) and Preferred Term (PT)
Measured: Baseline to 24 Weeks
Summary of Adverse Events by Severity
Summary of AEs by Category of Severity (Mild, Moderate, Severe)
Measured: Baseline to 24 Weeks
Serious Adverse Events (SAEs) and Deaths
Summary of Serious Adverse Events (SAEs) and Deaths
Measured: Baseline to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start17 Jun 2019
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Why it stopped: The DSMB concluded that there was a low probability the study would meet it is primary endpoint as designed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to treatment with TOL-3021 or placebo in a 2:1 fashion
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tolerion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Fleming, M.D., Study director, Tolerion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895437
- Sponsor's protocol ID
- TOL-3021-231
- Acronym
- SUNRISE
- Status last verified
- Dec 2021
- First submitted
- 26 Mar 2019
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We recognize that sharing anonymized data and other information from clinical trials can increase the speed and success of biomedical research in addressing unmet clinical need. We are following ongoing discussions among industry, the academic community, and other stakeholders regarding data sharing. Industry and its academic partners have not yet formulated a consensus on the amount, types, and forms of data that will be useful and beneficial to the public, or the process for sharing data. As a small, young company, we await the development of guidances and best practices for industry before issuing a comprehensive data sharing plan. For now, we defer a description of what data will be shared and the process for doing so. The protocol will be shared as part of study publication in a peer reviewed medical journal. The protocol will be available as a supplement to the publication and/or on the website of the publishing journal and upon request to the Sponsor (www.tolerion.bio)
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of TOL-3021 in Patients With New Onset or Established Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03895437
- Acronym / sponsor ID
- SUNRISE / TOL-3021-231
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes, Diabetes, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The DSMB concluded that there was a low probability the study would meet it is primary endpoint as designed.
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Tolerion, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up.
Detailed description
The SUNRISE study is a prospective, multi-center, double-blind, randomized, placebo-controlled trial in subjects aged 12.0 to <41.0 years diagnosed with type 1 diabetes (T1D), as defined by American Diabetes Association (ADA) criteria, and within 5 years of diagnosis. Time of diagnosis is defined as the first day of insulin administration. Subjects will be stratified by duration (zero up to 1 year and 1 year up to five years) to ensure balance of disease duration across treatment and placebo groups in each strata. For analytical purposes, all subjects12-<41 will be considered cohort A, subjects aged 12-<18 will considered cohort B and subjects aged 18-<41 will be considered cohort C. For subjects aged 12-<18 (Cohort B), dosing will be staggered with an initial 6 subjects aged 14-<18 being enrolled with the last subject a having a minimum of 2 injections with at least 1 week follow-up after the 2nd injection. Safety data from this cohort will be evaluated before opening the study to subjects 12 and older. Subjects should be randomized no sooner than 6 weeks after diagnosis, unless glycemic range is adequately controlled as confirmed by time in glycemic range (70-180 mg/dL) >55% by continuous glucose monitoring (CGM) recording over 3 or more consecutive or non-consecutive days. Screening assessments will include a physical examination, a fundoscopic photograph, chemistry and hematology safety labs, urinalysis, 24-hour urine protein and creatinine, hemoglobin A1c (HbA1c), presence of T1D antibodies, and a 4-hour mixed meal tolerance test (MMTT). Approximately 99 qualified subjects who meet all selection criteria will be randomized in a 2:1 ratio to treatment with TOL-3021 or placebo and treated for 52 weeks. Study drug treatments will be administered via an intramuscular (IM) injection into a large muscle every week for 52 weeks. CGM will be initiated within 5 days prior to the screening MMTT visit and continued through Week 52. Subjects will agree to diabetes management during the study with the goal of maintaining HbA1c levels of approximately 7.0% without frequent episodes of hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to treatment with TOL-3021 or placebo in a 2:1 fashion
| Arm | Type | Receives |
|---|---|---|
| TOL-3021 | Experimental | Biological: TOL-3021TOL-3021 2 mg/mL |
| TOL-3021 Placebo | Placebo comparator | Other: TOL-3021 PlaceboTOL-3021 Placebo |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association (ADA) criteria and within 5.0 years from diagnosis, defined as the first day of insulin administration.
- Age at randomization of 12.0 - <41.0 years of age .
- Adequate glycemic control as defined by HbA1c ≤7.9% based on point-of-care or local lab measurement and time in glycemic range (70-180 mg/dL) >55% by CGM recording over 3 or more consecutive or non-consecutive days within 5 days prior to baseline mixed meal tolerance test (MMTT).
- On insulin therapy (total insulin dose >0.125 U/kg body weight)
- Presence of antibodies to at least one of the following antigens: glutamic acid decarboxylase (GAD65), islet antigen 2 (IA-2), zinc transporter 8 (ZnT8), or insulin if obtained within 10 days of the onset of exogenous insulin therapy, or documentation of positive antibodies. In the absence of a positive result for one of the specified antibodies, diagnosis of T1D as per the ADA guidelines..
Key exclusion criteria (31 listed)
- Receiving a dose of acetaminophen >4,000 mg per day.
- Body Mass Index (BMI) >32 kg/m² for patients 18 and older (>85th percentile for ages 12-17)
- Previous immunotherapy for T1D within 2 years of enrollment.
- Diagnosis of liver disease or hepatic enzymes, as defined by alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of normal (ULN).
- Hematology: white blood cells (WBC) <3 x 10⁹/L; platelets <100 x 10⁹/L; hemoglobin <10.0 g/dL. (Low WBC values may be repeated every 3-7 days, and results to be discussed with the Medical Monitor.) Any underlying conditions likely to impact red blood cell turnover.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOL-3021TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene. | Biological | TOL-3021 |
| TOL-3021 PlaceboAlso: PlaceboTOL-3021 Placebo | Other | TOL-3021 Placebo |
Primary outcome
Change From Baseline on Log-transformed Mixed Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
Time frame: Baseline,12,16 and 24 weeks
The primary outcome is the TOL-3021 treatment effect as determined by a repeated measures analysis of change from baseline in the log-transformed MMTT C-peptide AUC at 12, 16, and 24 weeks
9 secondary outcomes
Hypoglycemia - % Time Continuous Glucose Monitor (CGM) Reading < 54 mg/dL
Time frame: Baseline, Weeks 1-12, Weeks 13-24
Hypoglycemia -Time CGM < 70 mg/dL
Time frame: Baseline, Weeks 1-12, Weeks 13-24
Severe Hypoglycemic Events Lasting at Least 15 Minutes
Time frame: Baseline, Weeks 1-12, Weeks 13-24
Treatment Effect on Daily Insulin Requirements
Time frame: Baseline, Weeks 1-12 and Weeks 13-24
Effect on Hemoglobin A1c (HbA1c)
Time frame: Baseline, 12, 16, 24 weeks
Number of Participants With Adverse Events (AEs)
Time frame: Baseline to 24 Weeks
Summary of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to 24 Weeks
Summary of Adverse Events by Severity
Time frame: Baseline to 24 Weeks
Serious Adverse Events (SAEs) and Deaths
Time frame: Baseline to 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We recognize that sharing anonymized data and other information from clinical trials can increase the speed and success of biomedical research in addressing unmet clinical need. We are following ongoing discussions among industry, the academic community, and other stakeholders regarding data sharing. Industry and its academic partners have not yet formulated a consensus on the amount, types, and forms of data that will be useful and beneficial to the public, or the process for sharing data. As a small, young company, we await the development of guidances and best practices for industry before issuing a comprehensive data sharing plan. For now, we defer a description of what data will be shared and the process for doing so. The protocol will be shared as part of study publication in a peer reviewed medical journal. The protocol will be available as a supplement to the publication and/or on the website of the publishing journal and upon request to the Sponsor (www.tolerion.bio)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Fleming, M.D. study director
Tolerion, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TOL-3021 in people with Diabetes Mellitus, Type 1, run by Tolerion, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on Log-transformed Mixed Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC) (time frame: Baseline,12,16 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.