GliomaPhase 3NCT06750458
Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
A Phase 3 study testing DexamethasoneGroup III (n=25) (Dexamethasone group) in people with Glioma and Dapagliflozin (Forxiga), run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the study is to compare between the role of dapagliflozin versus dexamethasone in pre-operative management of non-diabetic glioma patients on levetiracetam as anti-seizure drug. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma, Dapagliflozin (Forxiga), Dexamethasone
- What is being tested?
- DexamethasoneGroup III (n=25) (Dexamethasone group)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2025to 20 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males \& females.
- Age: between 18 and 75 years old.
- Pre-operative non-diabetic glioma patients on levetiracetam. • Diagnosis will be confirmed by:
- The initial clinical examination.
- Magnetic resonance imaging of the brain (MRI) with contrast.
Who cannot join
- Age: > 75 years old, and <18 years old.
- Breast feeding female. • Pregnant female.
- eGFR< 30 mL/minute/1.73 m2.
- Patients with diabetes mellitus.
- Patients with diabetic ketoacidosis.
- Patients with urinary tract infection.
Show all 10Show fewer
- Dehydrated patients till normalized.
- Lower limb amputation patients.
- SGLT2 inhibitors hypersensitivity.
- Severe hepatic patients (child-plug score class-c).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
The aim of the study is to compare between the role of dapagliflozin versus dexamethasone in pre-operative management of non-diabetic glioma patients on levetiracetam as anti-seizure drug.
Read the detailed description
- This is a randomized, parallel, and controlled study, which will be conducted on pre-operative non-diabetic glioma patients on levetiracetam as anti-seizure drug. * This study will be conducted pending registration at ClinicalTrials.gov.
- All patients will give their written informed consents.
- Data of patients will be confidential.
- Any unexpected risk will be reported to patients and Ethical Committee on time. * Randomization will be carried out based on days on hospital admission.
- Conditions
- Glioma, Dapagliflozin (Forxiga), Dexamethasone
- Being tested
- Dapagliflozin placebo, Placebo, DexamethasoneGroup III (n=25) (Dexamethasone group)
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin placeboDrug
Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dapagliflozin 10 mg once daily for 14 days pre-operative
PlaceboDrug
Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive placebo tablets once daily for 14 days pre-operative.
DexamethasoneGroup III (n=25) (Dexamethasone group)Drug
Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dexamethasone 8 mg tablets once daily for 14 days pre-operative.
| Study group | Role | What they receive |
|---|---|---|
| GroupⅠ(n=25) (Control group) | Placebo comparator | This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive placebo tablets once daily for 14 days pre-operative. Receives: Drug: Placebo |
| GroupII (n=25) (Dapagliflozin group) | Experimental | This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive Dapagliflozin 10 mg once daily for 14 days pre-operative. Receives: Drug: Dapagliflozin placebo |
| Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien | Active comparator | This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive Dexamethasone 8 mg tablets once daily for 14 days pre-operative. Receives: Drug: DexamethasoneGroup III (n=25) (Dexamethasone group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
•Magnetic resonance imaging of the brain (MRI) with contrast.
Measured: 2 weeks
Optic nerve sheath diameter for assessment of intracranial tension.
Measured: 2 weeks
Secondary outcomes (2)
Tumor necrosis factor alpha (TNF-α).
Measured: 2 weeks
Interlukin-6 (IL-6).
Measured: 2 weeks
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 start20 Jan 2025
- Primary completion20 Sep 2026
- Study completion20 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Khalifa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750458
- Sponsor's protocol ID
- 36265MD324/12/24
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Takashima M, Nakamura K, Kiyohara T, Wakisaka Y, Hidaka M, Takaki H, Yamanaka K, Shibahara T, Wakisaka M, Ago T, Kitazono T. Low-dose sodium-glucose cotransporter 2 inhibitor ameliorates ischemic brain injury in mice through pericyte protection without glucose-lowering effects. Commun Biol. 2022 Jul 2;5(1):653. doi: 10.1038/s42003-022-03605-4.
PubMed 35780235Shim B, Stokum JA, Moyer M, Tsymbalyuk N, Tsymbalyuk O, Keledjian K, Ivanova S, Tosun C, Gerzanich V, Simard JM. Canagliflozin, an Inhibitor of the Na+-Coupled D-Glucose Cotransporter, SGLT2, Inhibits Astrocyte Swelling and Brain Swelling in Cerebral Ischemia. Cells. 2023 Sep 6;12(18):2221. doi: 10.3390/cells12182221.
PubMed 37759444Saeedi S, Rezayi S, Keshavarz H, R Niakan Kalhori S. MRI-based brain tumor detection using convolutional deep learning methods and chosen machine learning techniques. BMC Med Inform Decis Mak. 2023 Jan 23;23(1):16. doi: 10.1186/s12911-023-02114-6.
PubMed 36691030Weller M, Wen PY, Chang SM, Dirven L, Lim M, Monje M, Reifenberger G. Glioma. Nat Rev Dis Primers. 2024 May 9;10(1):33. doi: 10.1038/s41572-024-00516-y.
PubMed 38724526
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT06750458
- Acronym / sponsor ID
- 36265MD324/12/24
- Conditions
- Glioma, Dapagliflozin (Forxiga), Dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 20 Sep 2026 (actual)
- 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 aim of the study is to compare between the role of dapagliflozin versus dexamethasone in pre-operative management of non-diabetic glioma patients on levetiracetam as anti-seizure drug.
Detailed description
- This is a randomized, parallel, and controlled study, which will be conducted on pre-operative non-diabetic glioma patients on levetiracetam as anti-seizure drug. * This study will be conducted pending registration at ClinicalTrials.gov.
- All patients will give their written informed consents.
- Data of patients will be confidential.
- Any unexpected risk will be reported to patients and Ethical Committee on time. * Randomization will be carried out based on days on hospital admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GroupⅠ(n=25) (Control group) | Placebo comparator | Drug: PlaceboThis group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive placebo tablets once daily for 14 days pre-operative. |
| GroupII (n=25) (Dapagliflozin group) | Experimental | Drug: Dapagliflozin placeboThis group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive Dapagliflozin 10 mg once daily for 14 days pre-operative. |
| Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien | Active comparator | Drug: DexamethasoneGroup III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive Dexamethasone 8 mg tablets once daily for 14 days pre-operative. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males \& females.
- Age: between 18 and 75 years old.
- Pre-operative non-diabetic glioma patients on levetiracetam. • Diagnosis will be confirmed by:
Key exclusion criteria (10 listed)
- Age: > 75 years old, and <18 years old.
- Breast feeding female. • Pregnant female.
- eGFR< 30 mL/minute/1.73 m2.
- Patients with diabetes mellitus.
- Patients with diabetic ketoacidosis.
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 placeboTwenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dapagliflozin 10 mg once daily for 14 days pre-operative | Drug | GroupII (n=25) (Dapagliflozin group) |
| PlaceboTwenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive placebo tablets once daily for 14 days pre-operative. | Drug | GroupⅠ(n=25) (Control group) |
| DexamethasoneGroup III (n=25) (Dexamethasone group)Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dexamethasone 8 mg tablets once daily for 14 days pre-operative. | Drug | Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien |
Primary outcome
•Magnetic resonance imaging of the brain (MRI) with contrast.
Time frame: 2 weeks
Optic nerve sheath diameter for assessment of intracranial tension.
Time frame: 2 weeks
2 secondary outcomes
Tumor necrosis factor alpha (TNF-α).
Time frame: 2 weeks
Interlukin-6 (IL-6).
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Results publication: PubMed 35780235Takashima M, Nakamura K, Kiyohara T, Wakisaka Y, Hidaka M, Takaki H, Yamanaka K, Shibahara T, Wakisaka M, Ago T, Kitazono T. Low-dose sodium-glucose cotransporter 2 inhibitor ameliorates ischemic brain injury in mice through pericyte protection without glucose-lowering effects. Commun Biol. 2022 Jul 2;5(1):653. doi: 10.1038/s42003-022-03605-4.
- Results publication: PubMed 37759444Shim B, Stokum JA, Moyer M, Tsymbalyuk N, Tsymbalyuk O, Keledjian K, Ivanova S, Tosun C, Gerzanich V, Simard JM. Canagliflozin, an Inhibitor of the Na+-Coupled D-Glucose Cotransporter, SGLT2, Inhibits Astrocyte Swelling and Brain Swelling in Cerebral Ischemia. Cells. 2023 Sep 6;12(18):2221. doi: 10.3390/cells12182221.
- Results publication: PubMed 36691030Saeedi S, Rezayi S, Keshavarz H, R Niakan Kalhori S. MRI-based brain tumor detection using convolutional deep learning methods and chosen machine learning techniques. BMC Med Inform Decis Mak. 2023 Jan 23;23(1):16. doi: 10.1186/s12911-023-02114-6.
- Results publication: PubMed 38724526Weller M, Wen PY, Chang SM, Dirven L, Lim M, Monje M, Reifenberger G. Glioma. Nat Rev Dis Primers. 2024 May 9;10(1):33. doi: 10.1038/s41572-024-00516-y.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DexamethasoneGroup III (n=25) (Dexamethasone group) in people with Glioma and Dapagliflozin (Forxiga), run by Tanta University at 1 site in Egypt.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 30 Sep 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
•Magnetic resonance imaging of the brain (MRI) with contrast. (time frame: 2 weeks). 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?
On the ClinicalTrials.gov record for NCT06750458, which also lists 4 linked publications.
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 30 Sep 2026.