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

NCT07586371 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: Allied Hospital Faisalabad
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Proteinuria; Diabetes (DM)

Keywords

proteinuria; diabetes mellitus; ARBs

Outcome Measures

Primary Outcomes (1)

• Percentage of efficacy

  will be labeled defined as reduction of 30% or more from baseline albuminuria

  one month

Study Arms (2)

ARBs alone

PLACEBO COMPARATOR

Group A patients will be prescribed ARBs (losartan 50 mg/day)

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)

Drug: ARBs in combination of SGLT2i

Interventions

ARBs alone DRUG

Group A patients will be prescribed ARBs (losartan 50 mg/day)

ARBs alone

ARBs in combination of SGLT2i DRUG

group-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day)

ARBs in combination of SGLT2i

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr Mudassar Saeed Pansota: lead

Study Sites (1)

Faisalabad Medical University

Faisalābad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Proteinuria; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): August 5, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

PA (1)