Is NCT05390892 recruiting in Johns Creek, GA?

Yes, NCT05390892 is currently recruiting participants at its Johns Creek, GA location. This type 2 diabetes clinical trial is actively enrolling qualified participants.

How do I join the type 2 diabetes clinical trial in Johns Creek?

To join this clinical trial in Johns Creek, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Johns Creek clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Type 2 Diabetes Clinical Trial in Johns Creek, GA

About This Type 2 Diabetes Study in Johns Creek

PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-

Sponsor: Brigham and Women's Hospital

Who Can Participate

Inclusion Criteria

Type 2 diabetes based on clinical diagnosis

HbA1c ≥6% measured within 12 months prior to screening

Secondary prevention cohort (at least 70% of cohort):

Age 40 to 80 years

Evidence of established atherosclerotic cardiovascular disease (ASCVD), as defined by one or more of the following

Coronary heart disease defined by at least one of the following: prior myocardial infarction, prior coronary percutaneous coronary intervention, ≥50% stenosis of a coronary artery documented by invasive or non-invasive imaging (including CT coronary angiography), positive stress test, or coronary artery calcium score \>400 Agatston units;

Cerebrovascular disease defined by at least one of the following: prior ischemic stroke, prior carotid revascularization procedure, carotid stenosis ≥ 50% documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound;

Symptomatic peripheral artery disease defined by at least one of the following: leg symptoms with an ABI ≤ 0.9, leg symptoms with imaging evidence of a stenosis ≥50% in a peripheral artery documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound, or prior amputation for atherosclerotic disease.

Primary prevention cohort (capped at 30% of cohort):

Age 60-80 years and at least 1 additional high-risk feature:

Cardiovascular risk factors/high-risk features:

Active smoking (combustible tobacco or marijuana)

HbA1c ≥ 8% measured within 12 months prior to screening. The most recent value available at the time of screening will be used for screening and to determine eligibility.

Stage 3a CKD, eGFR 45-59 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.

Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety

Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider.

If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes

Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities

Exclusion Criteria

Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)

Any background diabetes medication regimen will be allowed in this pragmatic trial with the following proviso: o Participants taking basal-bolus, prandial, or multiple daily injection insulin (MDI) regimens (e.g., short-acting in combination with long-acting insulin, called MDI regimens) are eligible only if the research staff attests that there has been communication with the usual diabetes care provider and that the provider has agreed to manage insulin adjustment with initiation of study medications. If such agreement has not been obtained, participants taking MDI regimens are excluded.

History of diabetic ketoacidosis

Active diabetic foot ulcer

History of pancreatitis

Heart failure as a primary reason for hospitalization within the past year

Known left ventricular ejection fraction \<40%

Known urinary albumin-to-creatinine ratio \>200 mg/g at screening

Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.

Known inability to afford study medication through current insurance coverage.

If a woman of child-bearing potential, the patient or partner is unwilling to use birth control

Active treatment for cancer, planned treatment for cancer, or recent active cancer with likelihood of recurrence or progression, which, in the opinion of the site investigator, has a likelihood of recurrence that would interfere with study therapy prior to 2028

Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy is allowed. Examples of allowable cancers include:

Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy

Prostate cancer being observed

Stage 0 or 1 tumors status post resection or other definitive treatment

Other similarly stable cancer comorbidities

History of solid organ or bone marrow transplant

Allergy to SGLT2 inhibitor or GLP-1 receptor agonist

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Johns Creek?

Yes, this clinical trial (NCT05390892) has an active research site in Johns Creek, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Type 2 Diabetes Treatment Options in Johns Creek, GA

If you're searching for type 2 diabetes treatment options in Johns Creek, GA, this clinical trial (NCT05390892) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Johns Creek research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced type 2 diabetes specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all type 2 diabetes clinical trials near you to find additional studies recruiting in your area.

Type 2 Diabetes Clinical Trial in Johns Creek, GA

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