NCT03573102

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 21, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

March 12, 2018

Last Update Submit

April 18, 2020

Conditions

Diabetic Nephropathies

Keywords

proteinuria , SGLT2 inhibitors , diabetes

Outcome Measures

Primary Outcomes (1)

  • decrease in proteinuria

    improvement of proteinuria in patients receiving dapagliflozine

    6 months

Study Arms (2)

control

ACTIVE COMPARATOR

ACE inhibitor , aspirin , statins will be given once daily

Drug: ACE inhibitor

cases

EXPERIMENTAL

SGLT2 inhibitors will be given with classic antiproteinuric drugs

Drug: SGLT2 inhibitorDrug: ACE inhibitor

Interventions

SGLT2 inhibitorDRUG

SGLT2 inhibitor 10 mg/day

Also known as: ACE Inhibitor
cases
ACE inhibitorDRUG

ACE inhibitor once daily

Also known as: Aspirin , statins
casescontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, 002, Egypt

RECRUITING

Related Publications (1)

  • Lotfy M, Adeghate J, Kalasz H, Singh J, Adeghate E. Chronic Complications of Diabetes Mellitus: A Mini Review. Curr Diabetes Rev. 2017;13(1):3-10. doi: 10.2174/1573399812666151016101622.

    PMID: 26472574BACKGROUND

MeSH Terms

Conditions

Diabetic NephropathiesProteinuriaDiabetes Mellitus

Interventions

Sodium-Glucose Transporter 2 InhibitorsAngiotensin-Converting Enzyme InhibitorsAspirinHydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of DrugsProtease InhibitorsEnzyme InhibitorsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesLipid Regulating AgentsTherapeutic Uses

Study Officials

  • Magdy Sharkawy, MD

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Magdy Sharkawy, MD

CONTACT

00201001422331magdi35@hotmail.com

Nahla H Tohami, MSc

CONTACT

00201003771280nahlatohami@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistent lecturer of nephrology

Study Record Dates

First Submitted

March 12, 2018

First Posted

June 29, 2018

Study Start

June 20, 2018

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

April 21, 2020

Record last verified: 2020-02

Locations

EG(1)