Phase 4 Type 1 Diabetes Trial, Recruiting NCT05498116 Sponsor: University of Colorado, Denver Condition: Type 1 Diabetes
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Phase 4 Type 1 Diabetes Trial, Recruiting

NCT05498116
Recruiting Phase 4

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 between 18 and 80 years old
  • You have had Type 1 diabetes for at least 5 years
  • Your urine test shows a certain level of protein (albumin) in your urine, within a specific range — your doctor can check this (confirm with trial site)
  • Your kidneys are working at a reduced but not severely low level, based on a blood test called eGFR (confirm with trial site)
  • Your blood pressure is below 140/90 before joining the trial
  • You are already taking a blood pressure medication called an ACE inhibitor or ARB, at the same dose for at least 4 weeks
  • Your BMI is under 40
  • Your overall blood pressure medication routine has been stable for at least one month before joining
  • Your insulin treatment routine (either an automated insulin pump system or multiple daily injections) has been stable for at least 4 weeks before joining
  • You are not very physically active — you do vigorous exercise no more than 2 days per week
  • You are able to give your own consent to participate

Who may not be able to join:

  • You have a serious health condition that your doctor believes means you are unlikely to live more than one year
  • Your blood pressure is not well controlled
  • There are concerns that you may have difficulty sticking to the study requirements
  • You are expected to need dialysis or a kidney transplant within the next 6 months
  • You are currently taking part in another research study
  • You are pregnant, planning to become pregnant, or currently breastfeeding
  • You have an allergy to aspirin
  • You have severe liver disease (confirm with trial site)
  • You have a history of a major psychiatric (mental health) disorder
  • You currently use steroid inhalers, steroid tablets, or certain long-acting breathing medications
  • You have a penicillin allergy
  • You have an iodine allergy
  • You have a shellfish allergy
  • You currently take any of these medications: phenobarbital, rifampin, or carbamazepine

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 2 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
26 January 2023
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Albuminuria

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: 2 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