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Empagliflozin for Type 2 Diabetes (EJB051 Trial)
EJB051 Trial 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.
- Type 2 Diabetes
- Insulin Sensitivity
EJB051 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EJB051 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Empagliflozin + mixed meal
- Group 2: Empagliflozin + insulin infusion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is senior citizens' participation in the trial being accepted?
"This research is searching for individuals between the ages of 18 years and 60 years old."
What is the typical rationale for prescribing Empagliflozin in combination with a mixed meal?
"Typically, cardiovascular diseases are managed with Empagliflozin + mixed meal. This combination of medications can also be utilized to help patients combat cardiovascular mortality, heart failure, and type 2 diabetes mellitus."
What is the maximum number of participants accepted into this research endeavor?
"Indeed, the latest information from clinicaltrials.gov confirms that this research endeavor is accepting new participants. The trial was established on February 1st 2020 and updated as recently as 9th of February 2022. 50 individuals are needed to participate at one location."
What other trials have been undertaken to study the effects of Empagliflozin when combined with a mixed meal?
"Presently, 49 medical trials related to Empagliflozin + mixed meal are ongoing with 13 studies at the Phase 3 stage. Additionally, there are over 1000 sites offering this research study worldwide; a majority of these locations being in Bourgas, Pennsylvania."
Is this research project a groundbreaking endeavor?
"Currently, there are 49 live studies for Empagliflozin + mixed meal spread across 43 nations and 237 cities. The inaugural research into this drug was conducted in 2018 by Boehringer Ingelheim; the trial involved 175 participants and concluded its Phase 3 approval stage. 177 investigations have been finished since then."
Might I be eligible for this research study?
"To partake in this research, individuals must be diagnosed with type2 diabetes and between 18 to 60 years of age. At present, the study is aiming to recruit approximately 50 participants."
Does this research endeavor currently have openings for participants?
"Per clinicaltrials.gov, this medical trial is still actively recruiting participants for its study. The initial posting date of the trial was February 1st 2020 and it has since been updated on February 9th 2022."
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