Active — Not RecruitingPhase 2

Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia

Mexico38 participantsStarted 2024-12-01

Plain-language summary

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 participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients over 18 years old admitted to the emergency department with a need for hospitalization, under the care of the Internal Medicine and Hemato-Oncology departments, from May to November 2024. * Patients with a clinical indication for high-dose glucocorticoid use (prednisone bioequivalence \>30mg/day). 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of glucocorticoid-induced hyperglycemia

Timeframe: until hospital discharge, an average of 10 days

hyperglycemia crisis

Timeframe: until hospital discharge, an avarage of 10 days

Trial details

NCT IDNCT06748105

SponsorLauro Fabián Amador Medina

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Dapagliflozin (Forxiga) trials