Dapagliflozin (Forxiga)Phase 2DAPACOIDNCT06748105
Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia
A Phase 2 study testing Dapagliflozin (DAPA) in people with Dapagliflozin (Forxiga) and Hyperglycaemia, run by Lauro Fabián Amador Medina at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dapagliflozin (Forxiga), Hyperglycaemia, Glucocorticoid
- What is being tested?
- Dapagliflozin (DAPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteMexico
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad Medica de Alta Especialidad Hospital de Especialidades No. 1 CMN Bajio
León, Guanajuato, 37366
About this study
Official title: Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia: Phase II Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
This clinical trial aims to evaluate the efficacy and safety of dapagliflozin in preventing glucocorticoid-induced hyperglycemia (GIH) in hospitalized patients who require high-dose glucocorticoid (GC) treatment. GCs are commonly used in clinical practice for their potent anti-inflammatory and immunosuppressive properties, but they are also a major cause of medication-induced hyperglycemia, particularly when administered at high doses.
The hypothesis of this trial is that dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, may reduce the incidence of GIH by counteracting the metabolic disturbances caused by GCs. Dapagliflozin works by inhibiting the SGLT2 protein, which is responsible for glucose reabsorption in the kidneys. By inhibiting this protein, dapagliflozin promotes glucose excretion in the urine, helping to reduce blood glucose levels. This mechanism is particularly relevant in the context of GIH, as GCs can impair insulin secretion, promote hepatic gluconeogenesis, and increase peripheral insulin resistance.
The primary aim of the study is to compare the incidence of GIH in patients receiving dapagliflozin versus those undergoing standard glucose monitoring (SGM) while on high-dose GCs. Secondary objectives include assessing the cumulative incidence of GIH days, the number of hyperglycemic crises, and the need for insulin therapy. The study also evaluates the safety profile of dapagliflozin, particularly focusing on any adverse events associated with its use in this population. The adverse effects of high-dose GCs will also be reported to provide a broader context for understanding the potential risks of treatment.
This randomized, open-label, controlled clinical trial will enroll hospitalized patients aged 18 and older who require high-dose GC therapy (prednisone equivalents >30 mg/day). The study will be conducted at the High Specialty Medical Unit, Hospital of Specialties No. 1, National Medical Center of Bajío, Mexican Institute of Social Security. Participants will be randomly assigned to one of two groups: the dapagliflozin group (10 mg/day) or the control group receiving standard glucose monitoring (SGM).
Both groups will undergo routine glucose monitoring through capillary glucose checks (three times daily) and fasting central glucose assessments. The study will be conducted during the patients' hospitalization, and participants will be followed until discharge or up to 10 days, whichever occurs first. The dosing schedule for dapagliflozin will ensure it is administered synchronously with the GC dose (within 12 hours of GC administration).
Additionally, data regarding the incidence of insulin therapy use, as well as the incidence and duration of hyperglycemic crises (defined as ≥2 persistent glucose readings ≥180 mg/dL within 24 hours), will be carefully recorded and analyzed. Adverse events will be monitored throughout the study, with particular attention to renal function, as SGLT2 inhibitors have been associated with potential renal side effects in some patient populations.
The statistical analysis will be based on comparing the two treatment arms for the incidence of GIH using appropriate methods, including Chi-square tests for categorical variables and Kaplan-Meier survival analysis for cumulative hyperglycemia-free days. All analyses will be conducted with a significance level set at p < 0.05, and SPSS v20 will be used for statistical processing.
The findings from this study could provide critical insights into the potential role of dapagliflozin in preventing GIH in high-risk hospitalized patients, improving patient outcomes, and offering a new therapeutic strategy in managing hyperglycemia associated with glucocorticoid therapy.
- Conditions
- Dapagliflozin (Forxiga), Hyperglycaemia, Glucocorticoid
- Being tested
- Dapagliflozin (DAPA)
- Keywords
- dapagliflozin, hyperglycaemia, glucocorticoid
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Dapagliflozin (DAPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: until hospital discharge, an avarage of 10 days
Secondary outcomes (2)
incidence of insulin therapy.
To determine the incidence (%) of insulin therapy use in both study arms.
Measured: until hospital discharge, an average of 10 days
Report adverse events.
Report adverse events associated (%) with dapagliflozin use in the study population
Measured: until hospital dischargte, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dapagliflozin (Forxiga)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lauro Fabián Amador Medina
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor-investigator, Lauro Fabián Amador Medina, Coordinación de Investigación en Salud, Mexico
- Investigators
- Lauro F Amador Medina, Dr, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748105
- Sponsor's protocol ID
- R-2024-1001-047
- Acronym
- DAPACOID
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It depends on whether participants choose to share their data with other researchers outside the protocol and informed consent for this study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin as Prophylaxis for Glucocorticoid-Induced Hyperglycemia: Phase II Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06748105
- Acronym / sponsor ID
- DAPACOID / R-2024-1001-047
- Conditions
- Dapagliflozin (Forxiga), Hyperglycaemia, Glucocorticoid
- Keywords
- dapagliflozin, hyperglycaemia, glucocorticoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Lauro Fabián Amador MedinaOther government
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial aims to evaluate the efficacy and safety of dapagliflozin in preventing glucocorticoid-induced hyperglycemia (GIH) in hospitalized patients who require high-dose glucocorticoid (GC) treatment. GCs are commonly used in clinical practice for their potent anti-inflammatory and immunosuppressive properties, but they are also a major cause of medication-induced hyperglycemia, particularly when administered at high doses.
The hypothesis of this trial is that dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, may reduce the incidence of GIH by counteracting the metabolic disturbances caused by GCs. Dapagliflozin works by inhibiting the SGLT2 protein, which is responsible for glucose reabsorption in the kidneys. By inhibiting this protein, dapagliflozin promotes glucose excretion in the urine, helping to reduce blood glucose levels. This mechanism is particularly relevant in the context of GIH, as GCs can impair insulin secretion, promote hepatic gluconeogenesis, and increase peripheral insulin resistance.
The primary aim of the study is to compare the incidence of GIH in patients receiving dapagliflozin versus those undergoing standard glucose monitoring (SGM) while on high-dose GCs. Secondary objectives include assessing the cumulative incidence of GIH days, the number of hyperglycemic crises, and the need for insulin therapy. The study also evaluates the safety profile of dapagliflozin, particularly focusing on any adverse events associated with its use in this population. The adverse effects of high-dose GCs will also be reported to provide a broader context for understanding the potential risks of treatment.
This randomized, open-label, controlled clinical trial will enroll hospitalized patients aged 18 and older who require high-dose GC therapy (prednisone equivalents >30 mg/day). The study will be conducted at the High Specialty Medical Unit, Hospital of Specialties No. 1, National Medical Center of Bajío, Mexican Institute of Social Security. Participants will be randomly assigned to one of two groups: the dapagliflozin group (10 mg/day) or the control group receiving standard glucose monitoring (SGM).
Both groups will undergo routine glucose monitoring through capillary glucose checks (three times daily) and fasting central glucose assessments. The study will be conducted during the patients' hospitalization, and participants will be followed until discharge or up to 10 days, whichever occurs first. The dosing schedule for dapagliflozin will ensure it is administered synchronously with the GC dose (within 12 hours of GC administration).
Additionally, data regarding the incidence of insulin therapy use, as well as the incidence and duration of hyperglycemic crises (defined as ≥2 persistent glucose readings ≥180 mg/dL within 24 hours), will be carefully recorded and analyzed. Adverse events will be monitored throughout the study, with particular attention to renal function, as SGLT2 inhibitors have been associated with potential renal side effects in some patient populations.
The statistical analysis will be based on comparing the two treatment arms for the incidence of GIH using appropriate methods, including Chi-square tests for categorical variables and Kaplan-Meier survival analysis for cumulative hyperglycemia-free days. All analyses will be conducted with a significance level set at p < 0.05, and SPSS v20 will be used for statistical processing.
The findings from this study could provide critical insights into the potential role of dapagliflozin in preventing GIH in high-risk hospitalized patients, improving patient outcomes, and offering a new therapeutic strategy in managing hyperglycemia associated with glucocorticoid therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin (DAPA)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. |
| Standard Monitoring Arm | Active comparator | Drug: Dapagliflozin (DAPA)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Dapagliflozin, Standard Monitoring Arm |
Primary outcome
Incidence of glucocorticoid-induced hyperglycemia
Time frame: until hospital discharge, an average of 10 days
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.
hyperglycemia crisis
Time frame: until hospital discharge, an avarage of 10 days
Hyperglycemic Crisis (HC): Defined as the persistence of ≥2 events of capillary or central glucose ≥180mg/dL (>10 mmol/L) within 24 hours.
2 secondary outcomes
incidence of insulin therapy.
Time frame: until hospital discharge, an average of 10 days
Report adverse events.
Time frame: until hospital dischargte, an average of 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. It depends on whether participants choose to share their data with other researchers outside the protocol and informed consent for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauro F Amador Medina, Dr principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin (DAPA) in people with Dapagliflozin (Forxiga) and Hyperglycaemia, run by Lauro Fabián Amador Medina at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of glucocorticoid-induced hyperglycemia (time frame: until hospital discharge, an average of 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.