Effect of Sodium Glucose co Transporter 2 Inhibitor ( SGLT2) on Proteinuria in Diabetic Patients

Phase 4

• Conditions: Diabetic Nephropathies
• Interventions: Drug: SGLT2 inhibitor; Drug: ACE inhibitor

• Registration Number: NCT03573102
• Lead Sponsor: Nahla H Tohami

Brief Summary

Diabetes Mellitus is the leading cause of end stage renal disease. As proven by many studies , controlling proteinuria can delay the progression to end stage renal disease.This work will study the effect of sodium glucose co transporter 2 inhibitor , a new antihyperglycemic drug , on proteinuria and to compare its effect with the effect of classic antiproteinuric drugs as angiotensin converting enzyme inhibitor , aspirin and statins.

Detailed Description

Diabetic nephropathy involves progressive stages including glomerular hyperfilteration , microalbuminuria , overt proteinuria and a decline in glomerular filteration rate leading to end stage renal disease.

Despite all the available interventions available for diabetic patients including tight glycemic control , and blood pressure control , using angiotensin converting enzyme inhibitors, angiotensin II receptor antagonist renal disease remains prevalent and progress in these patients.

The newer therapy of diabetes is the use of sodium glucose cotransporter 2 inhibitor as it has the potential of renoprotection in patients with diabetic nephropathy just as ACEI and ARBS to reduce glomerular hyperfilteration .This action may reduce albuminuria.

Study Timeline

• Study First Submitted: 2018-03-12
• Study Start: 2018-06-20
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-06-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-04-18
• Last Update Posted: 2020-04-21
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adult patients with type 2 diabetes.
• controlled diabetes.
• patients with proteinuria

Exclusion Criteria

• patients with proteinuria due to other disease.
• patients with HbA1c >8%.
• patients with uncontrolled hypertension.
• patients with chronic liver disease.
• patients with type 1 diabetes .
• patients already on the same drug ( dapagliflozine).
• patients with raised serum creatinine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cases	SGLT2 inhibitor	SGLT2 inhibitors will be given with classic antiproteinuric drugs
control	ACE inhibitor	ACE inhibitor , aspirin , statins will be given once daily
cases	ACE inhibitor	SGLT2 inhibitors will be given with classic antiproteinuric drugs

Primary Outcome Measures

Name	Time	Method
decrease in proteinuria	6 months	improvement of proteinuria in patients receiving dapagliflozine

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt