Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia (NCT06748105)
Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia: Phase II Randomized Clinical Trial
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to investigate whether dapagliflozin can help prevent glucocorticoid-induced hyperglycemia (GIH) in hospitalized patients requiring high-dose glucocorticoids (GCs). This trial will also assess the safety of dapagliflozin when used alongside GCs. The main questions the trial aims to answer are: Does dapagliflozin reduce the incidence of GIH in patients receiving high-dose GCs? What side effects or adverse events occur in patients taking dapagliflozin alongside high-dose GCs? Researchers will compare dapagliflozin to standard glucose monitoring (SGM) to determine if dapagliflozin is effective in preventing GIH in patients receiving high doses of GCs. Participants will: Take dapagliflozin (10 mg/day) or undergo standard glucose monitoring during their hospital stay. Visit the hospital for regular check-ups and glucose testing during their treatment. Record their glucose levels multiple times a day and report any adverse events they experience.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (9 items).
Location: Unidad Medica de Alta Especialidad Hospital de Especialidades No. 1 CMN Bajio — León, Guanajuato
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Current treatment with SGLT2 inhibitors, sulfonylureas, or insulin infusion pumps.
- Contraindications for SGLT2 inhibitors: chronic kidney disease (KDIGO stage IV), acute kidney injury or disease, type 1 diabetes, suspected severe acute infection, requirement for surgery, severe urinary tract infection.
- Previous use of high-dose glucocorticoids within the last 30 days. Indication for aggressive fluid resuscitation, use of vasopressors, use of mineralocorticoids, requirement for invasive mechanical ventilation, or classified as critically ill.
- Uncontrolled hyperglycemia (\>140mg/dL despite proper treatment) or suspected euglycemic diabetic ketoacidosis.
- Use of glucocorticoids in the past 28 days with doses higher than medium doses (prednisone equivalence \>10mg and \<30mg/day).
- Inability to take dapagliflozin orally.
- Pregnancy, postpartum, or lactation.
- Patients with incomplete follow-up or inadequate adherence to the intervention protocol, or those who experience adverse effects related to dapagliflozin use.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Unidad Medica de Alta Especialidad Hospital de Especialidades No. 1 CMN Bajio — León, Guanajuato
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Dapagliflozin (Forxiga) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.