Trial Search Results

Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients

The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with T1D followed by a 2-year safety follow-up.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Tolerion, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: TOL-3021
  • Other: TOL-3021 Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. 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.

   2. Age at randomization of 12.0 - <41.0 years of age .

   3. 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).

   4. On insulin therapy (total insulin dose >0.125 U/kg BW)

   5. Presence of antibodies to at least one of the following antigens: GAD65, IA-2, 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..

   6. Peak C-peptide during screening 4-hour mixed meal tolerance test (MMTT) ≥ 0.150
   nmol/L.

   7. 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.

   8. 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.

   9. Willingness and ability of subject to comply with all study procedures of the study
   protocol, including attending all clinic visits.

Exclusion Criteria

   1. Receiving a dose of acetaminophen >4,000 mg per day.

   2. Body Mass Index (BMI) >32 kg/m² for patients 18 and older (>85th percentile for ages
   12-17)

   3. Previous immunotherapy for T1D within 2 years of enrollment.

   4. Diagnosis of liver disease or hepatic enzymes, as defined by ALT and/or AST ≥ 2.5
   times the upper limit of normal (ULN).

   5. 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.

   6. Latent autoimmune diabetes of adults (LADA), which is generally associated with
   preceding history and treatment of T2D with medications typically used for treatment
   of T2D for more than 30 days.

   7. Monogenic diabetes (MODY).

   8. Estimated glomerular filtration rate (eGFR) <60 ml/min for ages 18-<41, and <75 ml/min
   per 1.73 m² for ages 12-<18.

   9. History of malignancy, except for cancers in remission >5 years, or basal cell or in
   situ squamous cell carcinoma of the skin.

10. 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.

11. Immunosuppressive therapy (systemic corticosteroids, cyclosporine, azathioprine, or
   biologics) within 30 days of screening.

12. Current or prior (within the last 30 days) use of metformin, sulfonylureas, glinides,
   thiazolidinediones, GLP1-RAs, DPP-IV inhibitors, pramlintide, or SGLT-2 inhibitors.

13. Current use of verapamil or α-methyldopa.

14. History of any organ transplant, including islet cell transplant.

15. Asthma that requires oral glucocorticoid therapy. Inhaled glucocorticoid therapy is
   permitted.

16. 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 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).

17. 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. .

18. Adrenal insufficiency not adequately controlled with stable replacement glucocorticoid
   therapy.

19. Moderate non-proliferative retinopathy (NPDR) or proliferative retinopathy

20. Evidence of infection with HBV (as defined by hepatitis B surface antigen, HBsAg), HCV
   (anti-HCV antibodies), or HIV.

21. Subject is breastfeeding.

22. 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).

23. Males of reproductive potential who are unwilling to use medically acceptable birth
   control, unless the female partner is postmenopausal or surgically sterile.

24. Any social condition or medical condition that would, in the opinion of the PI,
   prevent complete participation in the study or would pose a significant hazard to the
   subject's participation.

25. Anticipated major surgery during the duration of the trial, which could interfere with
   participation in the trial.

26. History of drug or alcohol dependence within 12 months of screening.

27. Psychiatric disorder that would prevent subjects from giving informed consent.

28. Household members of current participants in this protocol.

29. Subjects who are not fluent in the English language.

30. 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.

31. Any current use of biotin or biotin containing supplements

Ages Eligible for Study

12 Years - 40 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Trudy Esrey
650-498-4450
Recruiting