Phase 4 Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been clinically diagnosed with type 2 diabetes.
• People whose HbA1c blood sugar level was measured at 6% or higher within the past 12 months. (HbA1c is a blood test that shows average blood sugar levels over time.)
• People in the "secondary prevention" group (which makes up at least 70% of the trial) must be between 40 and 80 years old and have established heart or blood vessel disease, such as: a prior heart attack, a procedure to open blocked heart arteries, significant blockages in the heart or neck arteries confirmed by imaging, a positive heart stress test, a high calcium score in the heart arteries, a prior stroke, a procedure on the neck arteries, significant narrowing of the neck arteries, or leg artery disease with symptoms and confirmed blockage or prior amputation due to artery disease.
• People in the "primary prevention" group (capped at 30% of the trial) must be between 60 and 80 years old and have at least one additional high-risk feature, such as: currently smoking tobacco or marijuana, an HbA1c of 8% or higher measured in the past 12 months, or early-stage kidney disease with a specific kidney function score (eGFR between 45–59) measured in the past 12 months.
• People who are willing to be randomly assigned to one of the study medication types (SGLT2 inhibitors, GLP-1 receptor agonists, or both) and fill the prescription through their own pharmacy benefit, while allowing other medications to be adjusted for safety.
• People who are willing to avoid starting the other type of study medication unless their usual doctor strongly recommends it.
• People who are currently taking one of the study medication types and are willing to stop it and be randomly reassigned to one of the two medication groups.
• People who are willing to allow the trial to collect data from their electronic health records and to sign a release allowing access to future medical records from other healthcare providers.

Who may not be able to join:

• People who have a type of diabetes other than type 2, such as type 1 diabetes, diabetes caused by pancreas damage, or a rare inherited form of diabetes.
• People on an intensive insulin regimen (taking both short-acting and long-acting insulin daily) may not be eligible unless the research staff confirms that the person's usual diabetes doctor has agreed to manage insulin adjustments during the trial.
• People with a history of a serious complication called diabetic ketoacidosis (a dangerous build-up of acids in the blood related to diabetes).
• People with a currently active diabetic foot ulcer.
• People with a history of pancreatitis (inflammation of the pancreas).
• People who were hospitalised primarily for heart failure within the past year.
• People known to have a significantly reduced heart pumping function (left ventricular ejection fraction below 40%).
• People with a known high level of protein in their urine (albumin-to-creatinine ratio above 200 mg/g) at the time of screening.
• People whose kidney function score (eGFR) was measured below 45 ml/min/1.73m² in the past 12 months.
• People who are known to be unable to afford the study medication through their current insurance coverage.
• Women who could become pregnant, if neither the patient nor their partner is willing to use birth control during the trial.
• People currently receiving treatment for cancer, with planned cancer treatment, or with a recent cancer history where the trial site investigator believes there is a meaningful chance of the cancer returning or progressing before 2028. (Note: people with certain stable, well-controlled cancers may still be eligible — confirm with the trial site.)
• People who have had a solid organ transplant (such as a kidney or liver) or a bone marrow transplant.
• People with a known allergy to either of the study medication types (SGLT2 inhibitors or GLP-1 receptor agonists).

Important: Always verify eligibility with the trial site directly before applying.