Tubular Markers in Response to Saxagliptin Therapy

NCT04521049 | Completed Phase 4

• 1 other identifier: tubular markers
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

saxagliptin; uNGAL; u L-FABP; DKD

Outcome Measures

Primary Outcomes (3)

• to measure renal effect of saxagliptin on tubular markers

  the rate of change of uNGAL and u LFABP markers would be estimated across the two time points after saxagliptin treatment .

  3 months

• to measure effect of saxagliptin on renal on albuminuria

  the rate of change of UACR would be measured across the two time points after saxagliptin treatment

  3 months

• to classify renal responders to saxagliptin using tubular markers

  patients would be classified into high risk and low risk patients according to their marker levels

  3 months

Study Arms (2)

saxagliptin

ACTIVE COMPARATOR

patients received 5 mg daily ( 2.5 mg daily dose was given to patients with an eGFR of \<50 mL/min/1.73 m2

Drug: Saxagliptin 5mg

control

NO INTERVENTION

patients received the antihyperglycemic medication(s) such as metformin and/or sulphonyl ureas or insulin with no added gliptins,

Interventions

Saxagliptin 5mg DRUG

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

Also known as: Onglyza

saxagliptin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2 DM,
• prevalent albuminuria (30-3000mg/g),
• controlled hypertension (defined as blood pressure \<140/90 mm Hg) on a selected angiotensin receptor blocker, olmesartan 20mg/day for at least 4 weeks before intervention.

You may not qualify if:

• type 1 diabetes,
• poorly controlled hypertension (140-160/90-100 mm Hg),
• pancreatitis,
• malignancies
• albuminuria more than 3000mg/g.
• cardiovascular diseases (acute myocardial infarction, cerebrovascular disease in the past 6months,
• End Stage Renal Disease (ESRD) on chronic dialysis, renal transplant, a serum creatinine \>6.0 mg/dL, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Faculty of Pharmacy

Al Qāhirah al Jadīdah, 0004, Egypt

Location

Related Links

• Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase-4 Inhibition: A Hypothesis-Generating Analysis from the MARLINA-T2D Trial

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ahmed A Elberry, prof

  Clinical Pharmacology Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 20, 2020
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

EG (1)