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Tubular Markers in Response to Saxagliptin Therapy

NCT04521049 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-08-20

No results posted yet for this study

Summary

the study aims to investigate whether treatment with saxagliptin would induce beneficial changes in renal NGAL and L-FABP biomarkers and if they would be used as a tool to identify patients' categories with a particular renal response to DPP-4inhibition. Secondly, to find an association between NGAL and L-FABP, and the relevant renal parameters for both baseline values and rate of changes across defined time points.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Saxagliptin 5mg

Patients would be assigned to saxagliptin (Onglyza® AstraZeneca Pharmaceuticals LP, Indiana, USA), either received a dose of 5 mg or 2.5 mg daily if patients had eGFR \<50 mL/min/1.73 m2

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Ahmed A Elberry, prof · Clinical Pharmacology Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-03-01
Completion
2020-04-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04521049 on ClinicalTrials.gov