Type 1 DiabetesPhase 2/3NCT07591077
SGLT2 Adjunct in T1D
A Phase 2/3 study testing Empagliflozin (EMPA) in people with Type 1 Diabetes and Nephropathy, Diabetic, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents with Type 1 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Nephropathy, Diabetic
- What is being tested?
- Empagliflozin (EMPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2024to 20 Feb 2026
- Phase
- Phase 2/3
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with T1DM according to the international society of pediatric and adolescent diabetes (ISPAD). (Couper et al., ISPAD 2022).
- Age 10- 18 years old.
- Diabetic nephropathy according to ISPAD. (Couper et al., ISPAD 2022).
- eGFR > 30 ml/min per 1.73 m2
Who cannot join
- Patient with other types of diabetes e.g. T2DM, maturity onset diabetes of the young (MODY).
- Presence of contraindication for empagliflozin e.g. History of serious hypersensitivity reaction to empagliflozin, end-stage renal disease, or dialysis.
- Other types of nephropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents With Type 1 Diabetes Mellitus
Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents with Type 1 Diabetes Mellitus
Read the detailed description
Eighty six adolescents with T1D nephropathy according to the ISDAD 2022 guidelines were assigned into two equal groups randomly, one received empagliflozin initiated at 10 mg once daily in addition to their insulin therapy and the other received insulin therapy and placebo. Blood pressure percentiles, urine output, fasting lipids profile, HbA1C and CGM metrics were assessed at baseline, 3 and 6 months of therapy.
- Conditions
- Type 1 Diabetes, Nephropathy, Diabetic
- Being tested
- Empagliflozin (EMPA), Placebo
- Keywords
- SGLT2 inhibitors, type 1 diabetes, adolescents, Nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Nephropathies, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin (EMPA)Drug
empagliflozin oral once daily
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Active comparator | Empagliflozin 10 mg once daily Receives: Drug: Empagliflozin (EMPA) |
| Placebo | Placebo comparator | placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nephropathy
Change in the UACR after 6 months from baseline.
Measured: 6 months
Secondary outcomes (1)
Glycemic metrics
change in the glycemic metrics after 6 months from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start20 Nov 2024
- Primary completion20 Nov 2025
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran yousef, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591077
- Sponsor's protocol ID
- MS628/2024
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07591077
- Acronym / sponsor ID
- MS628/2024
- Conditions
- Type 1 Diabetes, Nephropathy, Diabetic
- Keywords
- SGLT2 inhibitors, type 1 diabetes, adolescents, Nephropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 15 May 2026 (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.
Effect of Sodium-Glucose Cotransporter (SGLT) 2 Inhibitors on Diabetic Nephropathy Progression in Adolescents with Type 1 Diabetes Mellitus
Detailed description
Eighty six adolescents with T1D nephropathy according to the ISDAD 2022 guidelines were assigned into two equal groups randomly, one received empagliflozin initiated at 10 mg once daily in addition to their insulin therapy and the other received insulin therapy and placebo. Blood pressure percentiles, urine output, fasting lipids profile, HbA1C and CGM metrics were assessed at baseline, 3 and 6 months of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Active comparator | Drug: Empagliflozin (EMPA)Empagliflozin 10 mg once daily |
| Placebo | Placebo comparator | Other: Placeboplacebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with T1DM according to the international society of pediatric and adolescent diabetes (ISPAD). (Couper et al., ISPAD 2022).
- Age 10- 18 years old.
- Diabetic nephropathy according to ISPAD. (Couper et al., ISPAD 2022).
- eGFR > 30 ml/min per 1.73 m2
Key exclusion criteria (3 listed)
- Patient with other types of diabetes e.g. T2DM, maturity onset diabetes of the young (MODY).
- Presence of contraindication for empagliflozin e.g. History of serious hypersensitivity reaction to empagliflozin, end-stage renal disease, or dialysis.
- Other types of nephropathy.
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 |
|---|---|---|
| Empagliflozin (EMPA)empagliflozin oral once daily | Drug | Empagliflozin |
| Placeboplacebo | Other | Placebo |
Primary outcome
Nephropathy
Time frame: 6 months
Change in the UACR after 6 months from baseline.
1 secondary outcome
Glycemic metrics
Time frame: 6 months
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 18 May 2026.
- 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 2/3 study testing Empagliflozin (EMPA) in people with Type 1 Diabetes and Nephropathy, Diabetic, run by Ain Shams 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 4 inclusion and 3 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 18 May 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 combined 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.
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?
Nephropathy (time frame: 6 months). 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 18 May 2026.