Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia

Sponsored by Lauro Fabián Amador Medina

About this trial

Last updated a year ago

Study ID

R-2024-1001-047

Status

Active not recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 7 months ago

What is this trial about?

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.

What are the participation requirements?

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.