Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia

NCT06748105 | Active Not Recruiting Phase 2

• 1 other identifier: R-2024-1001-047
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dapagliflozin; hyperglycaemia; glucocorticoid

Outcome Measures

Primary Outcomes (2)

• Incidence of glucocorticoid-induced hyperglycemia

  HIG (Severe Intermittent Hyperglycemia): Defined as the persistence of ≥2 events of capillary or central glucose ≥140mg/dL (7.8 mmol/L) within 24 hours.

  until hospital discharge, an average of 10 days

• hyperglycemia crisis

  Hyperglycemic Crisis (HC): Defined as the persistence of ≥2 events of capillary or central glucose ≥180mg/dL (\>10 mmol/L) within 24 hours.

  until hospital discharge, an avarage of 10 days

Secondary Outcomes (2)

• incidence of insulin therapy.

  until hospital discharge, an average of 10 days

• Report adverse events.

  until hospital dischargte, an average of 10 days

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Participants in this arm will receive dapagliflozin (10 mg/day) administered orally. The dose will be synchronized with glucocorticoid administration, with a maximum allowable time difference of 12 hours. Patients and their families will be trained in self-administration, and adherence will be monitored through nursing service reports.

Drug: Dapagliflozin (DAPA)

Standard Monitoring Arm

ACTIVE COMPARATOR

Participants will undergo standard glycemic monitoring (SGM), including preprandial capillary glucose measurements during three daily shifts and fasting central glucose assessments (6-8 hours fasting).

Drug: Dapagliflozin (DAPA)

Interventions

Dapagliflozin (DAPA) DRUG

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.

Dapagliflozin; Standard Monitoring Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lauro Fabián Amador Medina: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

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

León, Guanajuato, 37366, Mexico

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lauro F Amador Medina, Dr

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Protocol Design: Participants will be randomized 1:1, with group assignments known to all. Dapagliflozin (10 mg/day) will be administered orally within 12 hours of glucocorticoid dosing. Adherence will be ensured through patient/family training and nursing reports. Intervention Monitoring: Daily glucose levels will be assessed via preprandial capillary measurements (three shifts) and fasting central glucose (6-8 hours fasting). Standard glycemic monitoring (SGM) will also be performed. Definitions for Objectives: Hyperglycemia (HIG): ≥2 readings ≥140 mg/dL (7.8 mmol/L) in 24 hours. Hyperglycemic Crisis (HC): ≥2 readings ≥180 mg/dL (\>10 mmol/L) in 24 hours. If insulin or other antidiabetic treatments are initiated, they will be allowed alongside dapagliflozin in the intervention arm, with their use documented. Safety Monitoring: Adverse events will be recorded for all groups. Follow-up will continue until discharge, 10 days, or whichever occurs first.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)