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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02768220
• Other study ID #: SGLT2-AGE
• Status: Withdrawn
• Phase: Phase 4
• First received: May 9, 2016
• Last updated: February 13, 2018
• Start date: December 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Glycation End Products
• Diabetes
• SGLT-2 Inhibitors

Intervention

Drug:
• empagliflozin
Test to see how 30 days of jardiance changes serum and urinary advanced glycation end product levels
• linagliptin
Test to see how 30 days of tradjenta changes serum and urinary advanced glycation end product levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AGE levels	Measurement of serum and urinary AGE levels	30 days
Secondary	Change in blood pressure	measurement of BP	30 days
Secondary	Change in weight	measurement of weight	30 days