Phase 2 Type 1 Diabetes Trial, Recruiting NCT06524960 Sponsor: City of Hope Medical Center Condition: Type 1 Diabetes
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Phase 2 Type 1 Diabetes Trial, Recruiting

NCT06524960
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:

  • You are a woman aged 18–50 years old, or a man aged 21–50 years old
  • You have been diagnosed with type 1 diabetes based on standard medical criteria, such as specific blood sugar or HbA1c test results
  • You have a documented history of at least one diabetes-related antibody in your blood (such as GADA, IA-2A, or ZNT8A)
  • It has been at least 12 months but no more than 5 years since you were diagnosed with type 1 diabetes
  • Your body is still producing a small amount of insulin on its own, confirmed by a specific blood test called a C-peptide test
  • Your blood calcium level is within the normal range
  • If you are able to have children (male or female), you agree to use a highly effective form of birth control throughout the study and for at least 5 months after the last treatment

Who may not be able to join:

  • You had delayed puberty, unless an X-ray or scan has confirmed your bones are fully mature
  • You have taken part in another clinical trial or used another experimental treatment in the last 3 months
  • You have low vitamin D levels (below 30 ng/ml)
  • You have a history of anorexia or an eating disorder
  • Your BMI (body mass index) is above 32
  • Your HbA1c (a blood sugar control measure) is above 9.5%
  • You have had a severe low blood sugar episode or diabetic ketoacidosis (a serious diabetes complication) in the last 3 months (confirm with trial site if this happened 3–6 months ago)
  • You have used any diabetes medication other than insulin in the last 3 months (for example, metformin, GLP-1 medications, or SGLT2 inhibitors)
  • You have taken certain medications in the past year, including immune-suppressing drugs, certain steroids, bone-related treatments, or have ever taken bisphosphonate drugs (confirm with trial site for the full list)
  • You have had a broken bone (not including skull, face, hands, fingers, or toes) in the last 12 months
  • You have certain conditions affecting your bones or overall health, such as Paget's disease, liver disease, cancer, hormonal disorders, or regularly drink more than 3 units of alcohol per day (confirm with trial site for the full list)
  • You have significant dental or jaw problems, a history of jaw bone disease, ongoing dental treatment requiring surgery, or have planned invasive dental work during the study
  • You are currently pregnant, breastfeeding, have been breastfeeding within the last 6 months, or are planning to become pregnant within 5 months of your last treatment

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 19 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: Fouad Kandeel, MD, PhD, City of Hope Medical Center

Phone: 1-866-44-ISLET(1-866-444-7538)

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
Registry
ClinicalTrials.gov
Start date
3 September 2024
Est. completion
11 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Primary safety endpoint; Primary efficacy endpoint

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: 19 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