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Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 12 to 18

Repeated rituximab infusions for recent-onset type 1 diabetes in adolescents

Official title: Evaluation of Effectiveness and Safety of the Rituximab Immunotherapy Plus Insulin Therapy Compared to Insulin Therapy Alone in Adolescents With Recent-Onset Type 1 Diabetes Mellitus

Run by Pirogov Russian National Research Medical University · NCT07041268 · Data updated 2026-11-12

This test tries repeated rituximab infusions alongside regular insulin in adolescents 12–17 with recent-onset type 1 diabetes to see if it helps preserve their insulin-producing beta cells.

More Diabetes Mellitus, Type 1 trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages12 Years to 18 Years
SexAll
Enrollment116 (estimated)
SponsorPirogov Russian National Research Medical University
Academic / other
Drugs / interventionsrituximab
Locations2 sites (Moscow and 1 other locations)
StatusRecruiting
StartedApril 19, 2024
Main results expectedDecember 31, 2027
Study endsMarch 31, 2028
Registry record updatedJuly 8, 2025
Trial IDNCT07041268 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adolescents aged 12–17 who are Russian citizens, diagnosed with type 1 diabetes within the past four months, have a stimulated C‑peptide ≥200 pmol/L and a positive diabetes autoantibody are ideal candidates.

Probably not a fit

Patients with diabetes diagnosed more than four months earlier, very low or absent C‑peptide, active non-thyroid autoimmune disease, inability to attend frequent Moscow visits, or who do not meet age/weight/citizenship criteria are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized, open-label, two-arm study in which participants (or their guardians) choose either repeated rituximab infusions plus standard insulin therapy or insulin therapy alone. The rituximab arm receives 14 intravenous infusions over one year with 13 hospital visits, while the insulin-only arm attends five clinic visits over the same period. Beta-cell function will be tracked by mixed-meal tolerance tests measuring C‑peptide at baseline and at weeks 12, 19, 26, and 52 with samples taken fasting and at 15, 30, 60, 90, and 120 minutes. Enrollment is limited to Russian citizens aged 12–17 within four months of T1D diagnosis who have a stimulated C‑peptide ≥200 pmol/L and at least one diabetes autoantibody.

Why it matters

Potential benefit: If successful, repeated rituximab could slow loss of insulin-producing beta cells in adolescents with new-onset T1D, lowering insulin requirements and delaying diabetes-related complications.

How similar studies have gone: Prior clinical trials of rituximab in new-onset T1D showed transient preservation of C‑peptide for about a year, so this repeated-dosing approach builds on that limited, time-limited benefit.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Is 12 years to 17 years 5 months of age, inclusive, at the time of randomization/initiation of rituximab administration
* Body weight 34-80 kg for males, and 37-80 for females
* Has received a diagnosis of type 1 diabetes mellitus (T1D), ICD-10 codes E10.1 or E10.9, according to the criteria from the Russian Association of Endocrinologists
* The duration of T1D (time from diagnosis to screening) is \< 4 months
* Is able to be randomized and initiate rituximab infusions within 4 months (122 days) of the formal T1D diagnosis
* Has a peak stimulated C-peptide of ≥ 200 pmol/L from a MMTT at screening
* Is positive for at least one of T1D-related autoantibodies (ICA, GADA, IA-2A, ZnT8A) at screening
* Participant AND his/her legally authorized representative have signed the Informed Consent Form
* Citizenship of the Russian Federation

Exclusion Criteria:

* Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
* Has an active infection and/or fever
* Has a history of or serologic evidence of current or past infection with Mycobacterium tuberculosis, human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening
* Has a history of primary immunodeficiency
* Has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial
* Participant AND his/her legally authorized representative have not signed the Informed Consent Form

Where it's running

  • I.M. Sechenov First Moscow State Medical University (Sechenov University)
    Moscow, Russia     Recruiting
  • Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University
    Moscow, Russia     Recruiting

Study contacts

  • Principal investigator: Elena S Demina, M.D. — Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University
  • Study coordinator: Elena E Petryaykina, M.D.
  • Email: director@rdkb.ru
  • Phone: +79039756179

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.