Phase 2 Type 1 Diabetes Trial, Recruiting NCT07199946 Sponsor: Johnny Ludvigsson Condition: Type 1 Diabetes
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Phase 2 Type 1 Diabetes Trial, Recruiting

NCT07199946
Recruiting Phase 2

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 patient and their parent or caregiver must have given written consent to participate
  • The child must have been diagnosed with Type 1 diabetes (as defined by the American Diabetes Association) within the 3 months before the screening visit
  • The child must have been between 4 and 9 years old at the time of their Type 1 diabetes diagnosis
  • A blood test result called fasting C-peptide must be above a certain level (above 0.12 nmol/ml), which suggests the pancreas is still producing some insulin (confirm with trial site)
  • At least one diabetes-related antibody must be detected in the child's blood — these are markers the immune system produces that are linked to Type 1 diabetes (examples include GADA, IAA, IA-2A, or ZnT8A)

Who may not be able to join:

  • Children who have heart disease, an abnormal heart tracing (ECG), or a history of abnormal blood pressure
  • Children who have previously received or are currently receiving medicines that suppress the immune system (although steroid creams or steroid inhalers are accepted)
  • Children who are on ongoing treatment with anti-inflammatory medicines — occasional short-term use for things like headaches or fever is accepted
  • Children who are taking any diabetes medicines other than insulin, whether taken by mouth or by injection
  • Children who have a history of anaemia (low red blood cell levels) or who had significantly abnormal blood test results at screening
  • Children who have taken part in another clinical trial involving a new medicine within the 3 months before this trial
  • Children or families who are unwilling or unable to follow the trial requirements
  • Children who have had a significant illness other than diabetes in the 2 weeks before the first dose — however, children with well-managed coeliac disease or an underactive thyroid receiving adequate treatment may still be considered
  • Children who the trial investigator believes would have difficulty following instructions or the study procedures

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 28 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

Phone: +46706577234

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 2
Sponsor
Johnny Ludvigsson
Registry
ClinicalTrials.gov
Start date
6 August 2025
Est. completion
1 December 2029

Where this trial is recruiting

🇸🇪 Sweden

Primary endpoints

Change in C-peptide AUCmean 0-120 min) during an MMTT from baseline to month 24.; Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".

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: 28 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