Phase 4 Type 1 Diabetes Trial, Recruiting NCT03878459 Sponsor: The University of Texas Health Science Center at San Antonio Condition: Type 1 Diabetes
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Phase 4 Type 1 Diabetes Trial, Recruiting

NCT03878459
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:

  • People who are over 18 years old
  • People who have been diagnosed with Type 1 diabetes
  • People who are in good general health
  • People whose fasting C-peptide level (a marker of insulin production) is below 0.7 ng/ml
  • People whose blood sugar control (measured by HbA1c) is between 7.0% and 11.0%
  • People who manage their diabetes with multiple daily insulin injections or an insulin pump
  • People whose total daily insulin dose is at least 0.6 units per kilogram of body weight per day
  • People whose insulin dose has stayed roughly the same (within 4 units) over the past three months
  • People whose kidneys are functioning at a sufficient level, with an eGFR of 60 ml/min or above (confirm with trial site)
  • People whose weight has been stable (within about 3 pounds) over the past three months
  • People who do not take part in an excessively heavy exercise programme

Who may not be able to join:

  • People who have Type 2 diabetes
  • People whose daily insulin dose is less than 0.6 units per kilogram of body weight per day
  • People whose fasting C-peptide level is above 0.7 ng/ml
  • People whose HbA1c is below 7.0% or above 11.0%
  • People whose kidney function is below an eGFR of 60 ml/min
  • People who have blood detected in their urine
  • People who are pregnant, breastfeeding, have a positive pregnancy test, or are planning to become pregnant within the next year
  • Women of childbearing age who are not willing or able to use at least two barrier methods of contraception during the study
  • People who have a serious disease affecting a major organ system, including: a current or past cancer diagnosis (including bladder cancer); heart failure or a history of heart disease; chronic liver disease or abnormal liver test results; a history of alcohol or drug misuse; chronic lung conditions such as COPD or asthma; a history of rheumatic disease; a history of chronic pancreatitis or surgery on the pancreas; a history of stroke or mini-stroke (TIA); planned surgery during the study period; a history of HIV or other conditions that affect the immune system; a history of organ transplantation; or current use of medications other than insulin that are known to affect blood sugar levels (such as prednisone)
  • People who have advanced diabetic eye disease affecting the retina
  • People who follow a ketogenic (very low carbohydrate) diet
  • People who have been hospitalised in the past 6 months due to diabetic ketoacidosis, severe low blood sugar, or severely uncontrolled blood sugar
  • People who are currently experiencing symptoms of poor blood sugar control, such as excessive thirst or frequent urination
  • People who have had an allergic reaction to dapagliflozin or pioglitazone in the past

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

Contact this trial

Phone: 210 567 2391

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
The University of Texas Health Science Center at San Antonio
Registry
ClinicalTrials.gov
Start date
8 August 2019
Est. completion
1 June 2027

Where this trial is recruiting

🇮🇱 Israel Kuwait 🇺🇸 United States

Primary endpoints

Decrease in HbA1c

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: 20 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