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SGLT-2 Inhibitor
Empagliflozin for Type 2 Diabetes (EJB051 Trial)
Phase < 1
Waitlist Available
Led By Eugene J Barrett, MD PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between baseline and 12 weeks treatment
Awards & highlights
Summary
This trial will test whether a 12-week course of SGLT-2 inhibitor improves post-meal insulin action and cardiac muscle vascular function in patients with T2DM, and whether these changes are correlated with improved blood sugar control.
Eligible Conditions
- Type 2 Diabetes
- Insulin Sensitivity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between baseline and 12 weeks treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between baseline and 12 weeks treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Myocardial microvascular perfusion
Secondary study objectives
Augmentation Index ( AI)
Flow Mediated Dilation (FMD) Vascular measure of conduit artery stiffness Change in Flow Mediated Dilation (FMD) between baseline and after 2 hour insulin clamp Vascular measure of conduit artery stiffness Flow Mediated Dilation ( FMD)
Pulse Wave Velocity ( PWV)
Trial Design
2Treatment groups
Active Control
Group I: Empagliflozin + mixed mealActive Control1 Intervention
vascular measurements in overnight fasted state and 2 hours after mixed meal 10kcal/kg body weight ( 55% Cho, 30%Fat, 20% Pro)
Group II: Empagliflozin + insulin infusionActive Control1 Intervention
vascular measurements in overnight fasted state and during insulin infusion
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,157 Total Patients Enrolled
University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,247 Total Patients Enrolled
Eugene J Barrett, MD PhDPrincipal InvestigatorUniversity of Virginia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to perflutren, which is in the Definity medication.Your blood pressure is higher than 160 over 90.You have a body mass index (BMI) higher than 35.Your blood oxygen level is less than 90%.You have had a heart attack, stroke, or other blood vessel-related disease.You have had cancer or mental health issues in the past.You have a history of frequent urinary tract/bladder/kidney infections, and your kidney function is below a certain level.Your A1C level is between 6.5% and 9%.You have never taken medications like Jardiance, Invokana, Farxiga, or Steglatro.You have been taking the same dose of oral diabetes medication for more than 3 months.You weigh less than 35 units for your height.You have smoked in the last 6 months.Currently using insulin.You have a hole in your heart or lungs that we will check for during the physical exam.You have had heart problems, severe lung disease, or significant liver or kidney issues in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Empagliflozin + mixed meal
- Group 2: Empagliflozin + insulin infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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