Clinical trial NCT02768220: The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
Official title: The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: SGLT-2 Inhibitors
Advanced Glycation End Products
Diabetes
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in AGE levels
timeFrame: 30 days
Secondary outcomes:
measure: Change in blood pressure
timeFrame: 30 days
measure: Change in weight
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: