Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients (NCT03895437) | Clinical Trial Compass
TerminatedPhase 2
Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
Stopped: The DSMB concluded that there was a low probability the study would meet it is primary endpoint as designed.
United States78 participantsStarted 2019-06-17
Plain-language 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.
Who can participate
Age range
12 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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..
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — can you find out why it was stopped early, and what that means for how much we actually know about whether this treatment is safe or effective for Type 1 diabetes?
2Since this was a Phase 2 trial, it was still in a relatively early stage of testing — what does that tell us about how confident doctors can be about its risks and benefits compared to treatments that have already gone through full Phase 3 testing?
3The trial was measuring C-peptide levels through a mixed meal tolerance test, which reflects how much insulin the body is still producing — based on my current C-peptide levels, would I even have been a candidate for a study like this, and does that measurement matter for my treatment plan now?
4Because this trial is no longer recruiting and has been terminated, are there other active trials targeting Type 1 diabetes autoimmunity that might be worth looking into, or is standard insulin therapy the most appropriate path for me right now?
5Given that this study enrolled both newly diagnosed and established Type 1 diabetes patients, does the stage of my diagnosis — how recently I was diagnosed — affect which treatment options or trials might be most relevant for preserving whatever insulin production I may still have?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline on Log-transformed Mixed Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
. 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.
Exclusion criteria
. 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.