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Prevention study for Type2Diabetes
Official title PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
ClinicalTrials.gov ID: NCT05390892
What this study is testing
What is SGLT2 inhibitor?
SGLT2 inhibitor is an investigational medicine, being studied as a potential treatment for type2diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- History of diabetic ketoacidosis
- Active diabetic foot ulcer
- History of pancreatitis
- Heart failure as a primary reason for hospitalization within the past year
See the full eligibility 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...
- 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...
- 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...
- 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 assigned by chance 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- Johns Creek, Georgia, United States
- Suwanee, Georgia, United States
- Chicago, Illinois, United States
- Hinsdale, Illinois, United States
- Iowa City, Iowa, United States
- Fairway, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Duluth, Minnesota, United States
- Minneapolis, Minnesota, United States
- Columbia, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Miami, Florida, United States; Pembroke Pines, Florida, United States; Johns Creek, Georgia, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.