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ACTIVE NOT RECRUITING
NCT06748105
PHASE2

Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia

Sponsor: Lauro Fabián Amador Medina

View on ClinicalTrials.gov

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.

Official title: Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia: Phase II Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2024-12-01

Completion Date

2025-12-01

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

DRUG

Dapagliflozin (DAPA)

Participants will receive 10mg/day of dapagliflozin orally. The administration will occur within a "synchronous" range, meaning that the time difference between dapagliflozin administration and glucocorticoid administration should not exceed 12 hours.

Locations (1)

Unidad Medica de Alta Especialidad Hospital de Especialidades No. 1 CMN Bajio

León, Guanajuato, Mexico