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Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia

NCT06748105 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Dapagliflozin (Forxiga)
  • Hyperglycaemia
  • Glucocorticoid

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.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Lauro Fabián Amador Medina

    lead OTHER_GOV

Principal Investigators

  • Lauro F Amador Medina, Dr · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06748105 on ClinicalTrials.gov