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Combo Diabetes Drug for Type 2 Diabetes (PRECIDENTD Trial)

Phase 4

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Secondary prevention cohort (at least 70% of cohort): Age 40 to 80 years, Evidence of established atherosclerotic cardiovascular disease (ASCVD), as defined by: History of myocardial infarction or ischemic stroke or established coronary heart disease, or established peripheral artery disease, or established carotid artery atherosclerosis, or history of an arterial revascularization procedure of the coronary, peripheral, or cerebrovascular circulation

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), or HbA1c ≥ 8%, or Stage 3a CKD (eGFR 45-59 ml/min/1.73m2).

Must not have

Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, with an average follow up of approximately 3 years

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is designed to compare rates of the total number of cardiovascular, kidney, and death events among three alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD.

Who is the study for?

PRECIDENTD is for adults with type 2 diabetes who either have heart disease or are at high risk for it. They must be willing to switch their current medication and not start any excluded treatments during the trial. Key eligibility includes having a certain HbA1c level, being within specific age ranges, and agreeing to data collection. Pregnant women, those with recent severe heart failure or very low kidney function, active foot ulcers, or certain insulin uses are excluded.

What is being tested?

The trial tests three treatments: an SGLT2 inhibitor (SGLT2i), a GLP-1 receptor agonist (GLP-1 RA), and their combination in patients with type 2 diabetes at risk of cardiovascular events. It's randomized and open label; participants will be assigned equally to one of the treatment groups and monitored for heart attacks, strokes, hospitalizations due to heart failure, end-stage kidney disease, transplants, and death.

What are the potential side effects?

Possible side effects include urinary infections from SGLT2 inhibitors as they work by expelling excess glucose through urine. GLP-1 receptor agonists may cause digestive issues like nausea or vomiting because they slow down digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 80 years old with a history of heart or artery disease.

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I am 60-80 years old with high cardiovascular risk, like smoking, high HbA1c, or Stage 3a CKD.

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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, with an eGFR below 45.

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I, or my partner, am not willing to use birth control.

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I was hospitalized for heart failure in the last year or my heart pumps less blood than normal.

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My insurance does not cover the study medication.

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I have a form of diabetes not caused by lifestyle or type 2.

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I have an active foot ulcer due to diabetes.

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I have had pancreatitis before.

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I have had diabetic ketoacidosis in the past.

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I use fast-acting insulin with my long-acting insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, with an average follow up of approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, with an average follow up of approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, with an average follow up of approximately 3 years for reporting.