NCT02768220

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	empagliflozin	Test to see how 30 days of jardiance changes serum and urinary advanced glycation end product levels
DRUG	linagliptin	Test to see how 30 days of tradjenta changes serum and urinary advanced glycation end product levels

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-08-01
• Completion: 2018-12-01
• First posted: 2016-05-11
• Last updated: 2018-02-15