ProteinuriaPhase 2/3NCT07586371
Proteinuria in Normotensive Diabetic Patients: ARBs Alone or in Combination of SGLT2i
A Phase 2/3 study testing ARBs alone and ARBs in combination of SGLT2i in people with Proteinuria and Diabetes (DM), run by Dr Mudassar Saeed Pansota at 1 site in Pakistan.
Trial summary
Proteinuria is an early marker of diabetic kidney disease and predicts progression to chronic kidney disease and cardiovascular complications. ARBs are proven to reduce proteinuria and slow renal damage, even in normotensive diabetic patients. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Proteinuria, Diabetes (DM)
- What is being tested?
- ARBs alone and ARBs in combination of SGLT2i
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Apr 2026to 5 Aug 2026
- Phase
- Phase 2/3
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Age 30-60 years
- Diagnosed with diabetes
- Having microalbuminuria
Who cannot join
- Hypertension,
- Ischemic heart disease (IHD)
- Chromic kidney disease CKD (GFR < 60 ml/min),
- Nephrotic syndrome,
- Glomerulonephritis,
- Liver disease,
- Malignancy,
- hyperkalemia (potassium > 4.6 mmol/l)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of ARBs Alone or in Combination of SGLT2i in Management of Proteinuria in Normotensive Diabetic Patients
Proteinuria is an early marker of diabetic kidney disease and predicts progression to chronic kidney disease and cardiovascular complications. ARBs are proven to reduce proteinuria and slow renal damage, even in normotensive diabetic patients. SGLT2 inhibitors have recently shown additional reno-protective effects, including further reduction in proteinuria and slowing of disease progression. Combining ARBs with SGLT2 inhibitors may provide additive or synergistic benefits. However, there is limited data comparing ARBs alone versus the combination in normotensive diabetic patients. This study will provide evidence on the most effective strategy to reduce proteinuria, potentially lowering morbidity and preventing complications in this population
Read the detailed description
Diabetes mellitus is a kind of chronic and progressive disease with high prevalence. There will be 629 million diabetic patients by 2045. About 87% to 91% diabetic patients are probably T2DM in high income countries. Diabetic kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) worldwide and continues to be the major contributor to kidney replacement therapy (KRT).
Diabetic nephropathy (DN) refers to kidney damage caused by diabetes, which is one of the most common complications of diabetes. The main manifestations of DN are proteinuria, hypertension, and kidney function damage, which seriously affect the quality of life and long-term survival rate of patients. Currently, common treatments for DN in clinical practice include blood glucose control, blood pressure control and kidney protection therapy. Currently, agents such as ARBs are promising and have good availability to be used in advanced stages of CKD and4. However, the effects of ARBs on kidney outcomes, such as proteinuria unclear.
SGLT2i have become the new standard of care for slowing CKD progression in patients with T2DM due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects. Although SGLT2 inhibitors or ARBs have effects on albuminuria- and BP-lowering in patients with DKD, the effects of monotherapy are always unsatisfactory. Considering their complementary mechanisms on the kidneys, theoretically, SGLT2 inhibitors and ARBs should have synergistic action. Recently several studies indicated that the combination of SGLT2 inhibitors with ARBs satisfactorily afforded greater renoprotection than administration of either drug alone. These results demonstrated a long-term control of hyperglycemia and BP, reduction of hyperfiltration and proteinuria.
- Conditions
- Proteinuria, Diabetes (DM)
- Being tested
- ARBs alone, ARBs in combination of SGLT2i
- Keywords
- proteinuria, diabetes mellitus, ARBs
- Medical subject headings
- Proteinuria, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARBs aloneDrug
Group A patients will be prescribed ARBs (losartan 50 mg/day)
ARBs in combination of SGLT2iDrug
group-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| ARBs alone | Placebo comparator | Group A patients will be prescribed ARBs (losartan 50 mg/day) Receives: Drug: ARBs alone |
| ARBs in combination of SGLT2i | Experimental | group-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day) Receives: Drug: ARBs in combination of SGLT2i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of efficacy
will be labeled defined as reduction of 30% or more from baseline albuminuria
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start6 Apr 2026
- Primary completion5 Jul 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Mudassar Saeed Pansota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586371
- Sponsor's protocol ID
- Allied Hospital Faisalabad
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of ARBs Alone or in Combination of SGLT2i in Management of Proteinuria in Normotensive Diabetic Patients
- ClinicalTrials.gov ID
- NCT07586371
- Acronym / sponsor ID
- Allied Hospital Faisalabad
- Conditions
- Proteinuria, Diabetes (DM)
- Keywords
- proteinuria, diabetes mellitus, ARBs
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr Mudassar Saeed PansotaUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 5 Jul 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 14 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.
Proteinuria is an early marker of diabetic kidney disease and predicts progression to chronic kidney disease and cardiovascular complications. ARBs are proven to reduce proteinuria and slow renal damage, even in normotensive diabetic patients. SGLT2 inhibitors have recently shown additional reno-protective effects, including further reduction in proteinuria and slowing of disease progression. Combining ARBs with SGLT2 inhibitors may provide additive or synergistic benefits. However, there is limited data comparing ARBs alone versus the combination in normotensive diabetic patients. This study will provide evidence on the most effective strategy to reduce proteinuria, potentially lowering morbidity and preventing complications in this population
Detailed description
Diabetes mellitus is a kind of chronic and progressive disease with high prevalence. There will be 629 million diabetic patients by 2045. About 87% to 91% diabetic patients are probably T2DM in high income countries. Diabetic kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) worldwide and continues to be the major contributor to kidney replacement therapy (KRT).
Diabetic nephropathy (DN) refers to kidney damage caused by diabetes, which is one of the most common complications of diabetes. The main manifestations of DN are proteinuria, hypertension, and kidney function damage, which seriously affect the quality of life and long-term survival rate of patients. Currently, common treatments for DN in clinical practice include blood glucose control, blood pressure control and kidney protection therapy. Currently, agents such as ARBs are promising and have good availability to be used in advanced stages of CKD and4. However, the effects of ARBs on kidney outcomes, such as proteinuria unclear.
SGLT2i have become the new standard of care for slowing CKD progression in patients with T2DM due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects. Although SGLT2 inhibitors or ARBs have effects on albuminuria- and BP-lowering in patients with DKD, the effects of monotherapy are always unsatisfactory. Considering their complementary mechanisms on the kidneys, theoretically, SGLT2 inhibitors and ARBs should have synergistic action. Recently several studies indicated that the combination of SGLT2 inhibitors with ARBs satisfactorily afforded greater renoprotection than administration of either drug alone. These results demonstrated a long-term control of hyperglycemia and BP, reduction of hyperfiltration and proteinuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARBs alone | Placebo comparator | Drug: ARBs aloneGroup A patients will be prescribed ARBs (losartan 50 mg/day) |
| ARBs in combination of SGLT2i | Experimental | Drug: ARBs in combination of SGLT2igroup-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders
- Age 30-60 years
- Diagnosed with diabetes
- Having microalbuminuria
Key exclusion criteria (8 listed)
- Hypertension,
- Ischemic heart disease (IHD)
- Chromic kidney disease CKD (GFR < 60 ml/min),
- Nephrotic syndrome,
- Glomerulonephritis,
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 |
|---|---|---|
| ARBs aloneGroup A patients will be prescribed ARBs (losartan 50 mg/day) | Drug | ARBs alone |
| ARBs in combination of SGLT2igroup-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day) | Drug | ARBs in combination of SGLT2i |
Primary outcome
Percentage of efficacy
Time frame: one month
will be labeled defined as reduction of 30% or more from baseline albuminuria
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 14 May 2026.
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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 ARBs alone and ARBs in combination of SGLT2i in people with Proteinuria and Diabetes (DM), run by Dr Mudassar Saeed Pansota at 1 site in Pakistan.
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 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 14 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 Pakistan. 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?
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?
Percentage of efficacy (time frame: one month). 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 14 May 2026.