Phase 3 Type 1 Diabetes Trial, Recruiting NCT07258394 Sponsor: Nanjing Medical University Condition: Type 1 Diabetes
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Phase 3 Type 1 Diabetes Trial, Recruiting

NCT07258394
Recruiting Phase 3

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:

  • People who are willing and able to give written consent to take part
  • People aged between 18 and 65 years old
  • People who have been diagnosed with Type 1 Diabetes according to recognised 2024 medical guidelines
  • People whose blood tests show 2 or more specific markers (called autoantibodies) that are linked to Type 1 Diabetes — there is a special rule that applies if insulin has been used for more than 14 days, where at least 2 additional markers must be present (confirm with trial site)
  • People who were diagnosed with Type 1 Diabetes no more than 100 days before joining the trial
  • People whose blood test shows a certain level of a substance called C-peptide, which indicates the body is still producing some insulin (confirm with trial site for the specific value required)

Who may not be able to join:

  • People who are pregnant, breastfeeding, or people who could become pregnant and are not using contraception
  • People whose blood sugar is already well managed using only tablets (oral diabetes medication)
  • People who are currently taking part in another clinical trial related to diabetes or the immune system
  • People whose liver enzyme levels (measured by a blood test) are significantly higher than normal
  • People with a history of cancer, poorly controlled autoimmune conditions, or a current active infection
  • People with alcohol or drug dependency, certain psychiatric conditions, or other health circumstances that the trial team considers unsuitable for participation
  • People who have taken immune-suppressing medications within the 12 weeks before joining
  • People who have taken part in any other drug trial within the 12 weeks before joining
  • People with a known history of serious drug allergies, hypersensitivity reactions, or drug addiction
  • People whose overall health situation is considered by the research team to be unsuitable for the trial

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 3: approximately ~65% 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

Phone: +86 13814084876

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.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Nanjing Medical University
Registry
ClinicalTrials.gov
Start date
27 January 2026
Est. completion
31 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Baseline-adjusted geometric mean area under the serum C-peptide curve (C-peptide AUC) during a 2-hour mixed-meal tolerance test (MMTT) 24 weeks post-intervention.

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