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Dapagliflozin for Type 2 Diabetes (SFRNDM2 Trial)
SFRNDM2 Trial Summary
This trial will help researchers understand how the medication dapagliflozin affects vascular health in patients with Type 2 Diabetes Mellitus, in hopes of reducing the risk of developing heart attacks or strokes.
SFRNDM2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSFRNDM2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 30 Patients • NCT03006471SFRNDM2 Trial Design
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- I have been diagnosed with type 2 diabetes for at least 3 months.I do not have any major illnesses like severe kidney problems or other cancers.I am currently on blood thinners.I have had 3 or more urinary tract infections in the last year.You have had an allergic reaction to a SGLT-2 inhibitor before.You have had more than one genital yeast infection in the past two years.I am taking medication for diabetes that belongs to the SGLT-2 inhibitors class.Your average blood sugar level (HbA1c) has been higher than 9.5% in the last 3 months.I've had more than one low blood sugar event in the past 6 months or my HbA1c is below 7.0%.I have had bladder cancer or radiation treatment in the pelvic area.Your top blood pressure number is less than 120.Your body mass index (BMI) is higher than 25.
- Group 1: Dapagliflozin then Placebo
- Group 2: Placebo then dapagliflozin
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Who has been deemed suitable to take part in this experiment?
"This investigation requires 50 subjects, aged 30 to 75 years old with pre-existing Type 2 diabetes Mellitus. Additionally, the prospective participants must have a fasting glucose greater than 120 mg/dL, an HbA1C reading of 6.5% or higher, and BMI >25 as well as express willingness to provide written consent for their participation in this research trial while comprehending its fundamental requirements."
How many participants are being enrolled in this experiment?
"Affirmative. Clinicaltrials.gov's information implies that this research is actively recruiting patients, which was first announced on May 31st 2022 and modified recently on June 1st 2022. The study necessitates 50 individuals from a single clinical centre."
Has the United States Food and Drug Administration sanctioned Dapagliflozin?
"Our evaluation of Dapagliflozin's safety has resulted in a score of 3, as it is currently approved for use due to its successful Phase 4 trial."
Are there any available slots remaining for participants in this research?
"Indeed, the information hosted on clinicaltrials.gov reveals that this medical study is actively attempting to enroll patients and has been since May 31st 2022. As of June 1st 2022, the trial needs 50 volunteers from a single site."
What objectives is this trial attempting to fulfill?
"The main outcome to be quantified over the 14-week trial duration is Insulin-mediated eNOS phosphorylation in ECs at 6 weeks. Secondary objectives involve analysing coding RNA from ECs and ncRNA from plasma at 14 weeks, as well as measuring noncoding RNA levels from ECs when the study reaches its sixth week mark."
What pathologies is Dapagliflozin typically employed to ameliorate?
"Dapagliflozin is frequently utilized in pharmaceutical preparations to treat a range of issues, including dietary restrictions, physical activity levels, and inadequate response to single-drug therapy."
Is this trial open to adults of all ages?
"The criteria for enrolment in this experiment stipulates that patients must be between 30 and 75 years of age. For those younger than 18, there are 198 studies available while 1157 exist to accommodate seniors over 65."
Is this clinical experiment a pioneering endeavor?
"Presently, over 235 cities and 50 countries are hosting 63 active studies related to Dapagliflozin. This medication was first clinically tested in 2014 by AstraZeneca with 700 participants; since then, a total of 18457 trials have been conducted."
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