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NCT Number: NCT07586371

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Proteinuria Diabetes (DM) Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faisalabad Medical University

Faisalābad, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ARBs alone

Drug

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

ARBs in combination of SGLT2i

Drug

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

Primary outcomes

  1. Percentage of efficacy

    Time frame: one month

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

Sponsors and collaborators

Lead sponsor

Dr Mudassar Saeed Pansota

Other

Registry information

Official study title

Comparative Analysis of ARBs Alone or in Combination of SGLT2i in Management of Proteinuria in Normotensive Diabetic Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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