Phase 3 Type 1 Diabetes Trial, Recruiting NCT07548996 Sponsor: Nanjing Medical University Condition: Type 1 Diabetes
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Phase 3 Type 1 Diabetes Trial, Recruiting

NCT07548996
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 to take part and are able to sign a consent form agreeing to participate
  • People aged between 18 and 65 years
  • People who have been diagnosed with type 1 diabetes according to American Diabetes Association 2024 guidelines
  • People who test positive for at least 2 specific markers in the blood that are linked to type 1 diabetes (these are called islet autoantibodies, and the ones tested include IAA, GADA, IA-2A, ICA, and ZnT8A)
  • People who have a blood test result showing a certain level of a substance called C-peptide (200 pmol/L or above), which indicates the body is still producing some insulin
  • Note: People who have been using insulin for more than 14 days must test positive for at least 2 of these markers other than IAA (confirm with trial site)

Who may not be able to join:

  • People who are pregnant, breastfeeding, have a positive pregnancy test at the screening visit, or where pregnancy cannot be ruled out in the opinion of the trial doctor
  • People whose blood sugar is well controlled by diabetes tablets alone, without insulin
  • People currently taking part in other studies involving diabetes treatment or immune system therapies
  • People with liver test results (ALT or AST) that are more than 3 times the accepted normal range
  • People with reduced kidney function or signs of kidney damage, including certain test results below or above acceptable ranges, or other kidney conditions the trial doctor considers unsuitable (confirm with trial site)
  • People with a history of cancer, an uncontrolled immune system condition, or an uncontrolled infection
  • People with alcohol or drug misuse, a psychiatric condition, or other circumstances the trial doctor considers unsuitable for taking part in a drug trial
  • People who have taken immune-suppressing medications within the 12 weeks before joining the trial
  • People who have taken part in any other drug trial within the 12 weeks before joining this trial
  • People with a history of multiple drug allergies, allergic conditions, a tendency toward allergic reactions, or drug dependence
  • People with any other health condition or circumstance that, in the trial doctor's opinion, may affect participation or results

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 23 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

Principal Investigator: Yong Gu, Department of Endocrinology, Jiangsu Provincial Hospital

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 April 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 During a 2-Hour 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: 23 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