The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products

NCT02768220 | Withdrawn Phase 4

• 1 other identifier: SGLT2-AGE
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration.

Conditions

SGLT-2 Inhibitors; Advanced Glycation End Products; Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in AGE levels

  Measurement of serum and urinary AGE levels

  30 days

Secondary Outcomes (2)

• Change in blood pressure

  30 days

• Change in weight

  30 days

Study Arms (2)

Linagliptin

ACTIVE COMPARATOR

Eligible patients were randomized to receive linagliptin 5mg daily for 30 days.

Drug: empagliflozin

Empagliflozin

EXPERIMENTAL

Eligible patients were randomized empagliflozin 25mg daily for 30 days.

Drug: linagliptin

Interventions

empagliflozin DRUG

Test to see how 30 days of jardiance changes serum and urinary advanced glycation end product levels

Also known as: Jardiance

Linagliptin

linagliptin DRUG

Test to see how 30 days of tradjenta changes serum and urinary advanced glycation end product levels

Also known as: tradjenta

Empagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2DM
• Age ≥ 18
• glomerular filtration rate ≥ 30 ml/min/1.73 m2 body-surface area
• A1C ≥ 7% any higher limit
• SLGT-2 inhibitor naïve
• On stable doses of current medications for at least 3 months.

You may not qualify if:

• Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 2 x upper limit of normal during screening or run-in phase
• Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
• Contraindications to background therapy according to the local label
• Any uncontrolled endocrine disorder except type 2 diabetes
• Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who were nursing, pregnant, or of child-bearing potential and were not practicing an acceptable method of birth control, or did not plan to continue using this method throughout the study, or did not agree to submit to periodic pregnancy testing during the trial
• o Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method, vasectomy of partner
• Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
• Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up

Sponsors & Collaborators

• Northwell Health: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

empagliflozin; Linagliptin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

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

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: December 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share