Phase 2 Type 1 Diabetes Trial, Recruiting (NCT07041268)

Phase 2 Type 1 Diabetes Trial, Recruiting NCT07041268 Sponsor: Pirogov Russian National Research Medical University Condition: Type 1 Diabetes

Printed from Voxsanity (voxsanity.com.au) — NCT07041268 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Type 1 Diabetes

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

The participant is between 12 years old and 17 years and 5 months old at the time of joining the trial
Body weight falls within the required range — 34 to 80 kg for males, and 37 to 80 kg for females
A diagnosis of type 1 diabetes has been made according to the criteria of the Russian Association of Endocrinologists
The type 1 diabetes diagnosis was made less than 4 months ago at the time of screening
The trial treatment can be started within 4 months (122 days) of the formal type 1 diabetes diagnosis
A specific blood test done at screening (called an MMTT) shows that the pancreas is still producing some insulin — at a level of at least 200 pmol/L
At least one diabetes-related immune marker (called an autoantibody — such as ICA, GADA, IA-2A, or ZnT8A) is found in the blood at screening
Both the participant and their parent or legal guardian have signed the consent form agreeing to take part
The participant holds Russian Federation citizenship

Who may not be able to join:

The participant has an autoimmune disease in addition to type 1 diabetes, unless it is a stable thyroid condition or stable coeliac disease
The participant currently has an active infection or fever
Blood tests or medical history show a past or current infection with tuberculosis, HIV, hepatitis B, or hepatitis C
The participant has a history of a condition where the immune system does not work properly from birth (primary immunodeficiency)
In the opinion of the lead investigator, a medical, psychological, or social condition exists that could interfere with the participant's safety or ability to complete the trial
The participant and/or their parent or legal guardian has not signed the required consent form

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 21 July 2026

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Dmitry M Chudakov, Ph.D., D.Sc., Institute of Translational medicine, Pirogov Russian National Research Medical University

Phone: +79039756179

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07041268

Sponsor: Pirogov Russian National Research Medical University

Phase: Phase 2

Status: Recruiting

Condition: Type 1 Diabetes

Trial contact: +79039756179

More information: https://clinicaltrials.gov/study/NCT07041268

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

The participant is between 12 years old and 17 years and 5 months old at the time of joining the trial
Body weight falls within the required range — 34 to 80 kg for males, and 37 to 80 kg for females
A diagnosis of type 1 diabetes has been made according to the criteria of the Russian Association of Endocrinologists
The type 1 diabetes diagnosis was made less than 4 months ago at the time of screening
The trial treatment can be started within 4 months (122 days) of the formal type 1 diabetes diagnosis
A specific blood test done at screening (called an MMTT) shows that the pancreas is still producing some insulin — at a level of at least 200 pmol/L
At least one diabetes-related immune marker (called an autoantibody — such as ICA, GADA, IA-2A, or ZnT8A) is found in the blood at screening
Both the participant and their parent or legal guardian have signed the consent form agreeing to take part
The participant holds Russian Federation citizenship

Who may not be able to join:

The participant has an autoimmune disease in addition to type 1 diabetes, unless it is a stable thyroid condition or stable coeliac disease
The participant currently has an active infection or fever
Blood tests or medical history show a past or current infection with tuberculosis, HIV, hepatitis B, or hepatitis C
The participant has a history of a condition where the immune system does not work properly from birth (primary immunodeficiency)
In the opinion of the lead investigator, a medical, psychological, or social condition exists that could interfere with the participant's safety or ability to complete the trial
The participant and/or their parent or legal guardian has not signed the required consent form

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 21 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 2

Sponsor

Pirogov Russian National Research Medical University

Registry

ClinicalTrials.gov

Start date

19 April 2024

Est. completion

31 December 2027

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

Change in the Mean C-peptide Area Under Curve (AUC) Standardized by Duration of the Mixed Meal Tolerance Test

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov