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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

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total (first and recurrent) cardiovascular, kidney, and death events

Trial Design

2Treatment groups
Active Control
Group I: Sodium-glucose cotransporter-2 inhibitor (SGLT2i)Active Control1 Intervention
Therapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin
Group II: Glucagon-like peptide-1 receptor agonist (GLP-1 RA)Active Control1 Intervention
Therapy with a GLP-1 RA with proven cardiovascular benefit. This means either dulaglutide, liraglutide, or semaglutide.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,485,035 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
568 Previous Clinical Trials
27,243,409 Total Patients Enrolled

Media Library

Combination drug Clinical Trial Eligibility Overview. Trial Name: NCT05390892 — Phase 4
Type 2 Diabetes Research Study Groups: Sodium-glucose cotransporter-2 inhibitor (SGLT2i), Glucagon-like peptide-1 receptor agonist (GLP-1 RA)
Type 2 Diabetes Clinical Trial 2023: Combination drug Highlights & Side Effects. Trial Name: NCT05390892 — Phase 4
Combination drug 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390892 — Phase 4
~4000 spots leftby Mar 2029
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