Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT03895437

Run by

Tolerion, Inc.

People needed

78

Starts

2019-06-17

Expected to finish

2020-12-21

Last updated by the study team

2026-05-20

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Altman Clinical and Translational Research Institute UCSD — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Mills-Peninsula Medical Center — San Mateo, California, United States
• Stanford University — Stanford, California, United States
• Barbara Davis Center - University of Colorado Denver — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Baptist Health Research Institute — Jacksonville, Florida, United States
• University of Miami Diabetes Research Institute — Miami, Florida, United States
• University of South Florida Diabetes Center — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• University of Iowa — Iowa City, Iowa, United States
• MedStar Health Research Institute — Baltimore, Maryland, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• Joslin Diabetes Center- Adult & Pediatric — Boston, Massachusetts, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Naomi Berrie Diabetes Center, Columbia University — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Mountain Diabetes and Endocrine Center — Asheville, North Carolina, United States
• University of North Carolina Diabetes Care Center — Chapel Hill, North Carolina, United States
• Diabetes and Glandular Disease Clinic, P.A. — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.