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

Northwell Health

Status and phase

Withdrawn

Phase 4

Conditions

Diabetes

Advanced Glycation End Products

SGLT-2 Inhibitors

Treatments

Drug: linagliptin

Drug: empagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT02768220

SGLT2-AGE

Details and patient eligibility

About

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.

Full description

Single-center open-label multiple dose randomized two period cross-over study.

The North-Shore Long Island Jewish Institutional Review Board will be used to approve our study protocol.

All patients will give written informed consent and comply with the Helsinki agreement and good clinical practices guidelines.

Treatment Plan:

Eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. All pre-existing diabetic medications will continue unchanged.

Fasting blood carboxymethyl lysine (CML), methylglyoxal (MG), vascular cell adhesion molecule (VCAM), tumor necrosis factor (TNF) alpha, 8-isoprostane, and routine chemistries and urinary CML, MG, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days.

AGE levels will be measured by Elisa.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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