Proteinuria in Normotensive Diabetic Patients: ARBs Alone or in Combination of SGLT2i

May 7, 2026 updated by: Dr Mudassar Saeed Pansota

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan
        • Faisalabad Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both genders
  • Age 30-60 years
  • Diagnosed with diabetes
  • Having microalbuminuria

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ARBs alone
Group A patients will be prescribed ARBs (losartan 50 mg/day)
Drug: ARBs alone
Group A patients will be prescribed ARBs (losartan 50 mg/day)
Experimental: ARBs in combination of SGLT2i
group-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day)
Drug: ARBs in combination of SGLT2i
group-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of efficacy
Time Frame: one month
will be labeled defined as reduction of 30% or more from baseline albuminuria
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Mudassar Saeed Pansota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2026

Primary Completion (Estimated)

July 5, 2026

Study Completion (Estimated)

August 5, 2026

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Allied Hospital Faisalabad

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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