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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion on may 1, 2028, an average of 3 years of follow up for each participant
Awards & highlights

PRECIDENTD Trial 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.Check my eligibility
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.See study design
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.

PRECIDENTD Trial 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.

PRECIDENTD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion on may 1, 2028, an average of 3 years of follow up for each participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion on may 1, 2028, an average of 3 years of follow up for each participant for reporting.

Treatment Details

Study Objectives

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

PRECIDENTD Trial Design

3Treatment 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.
Group III: Combination SGLT2i and GLP-1 RAActive Control1 Intervention
Combination therapy with an SLGT2i (canagliflozin, dapagliflozin, or empagliflozin) AND a GLP-1 RA (dulaglutide, liraglutide, or semaglutide)

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,461,830 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,988,448 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), Combination SGLT2i and 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Glucagon-like peptide-1 receptor agonist (GLP-1 RA)?

"With GLP-1 RA being a Phase 4 trial, meaning it has already been approved for use, our evaluation team has deemed its safety level to be 3."

Answered by AI

Are the researchers currently seeking participants for this investigation?

"The latest figures on clinicaltrials.gov suggest that this investigation is actively recruiting volunteers, with the trial first being posted on September 1st 2022 and most recently edited in late September of the same year."

Answered by AI

How many participants are being recruited for this medical experiment?

"Affirmative. Clinicaltrials.gov corroborates that this investigation, which was first listed on September 1st 2022, is actively seeking participants. Approximately 9000 individuals must be enrolled from 2 distinct medical sites."

Answered by AI

Does this research endeavor extend to the elderly population?

"According to the parameters of this research endeavour, participants must be between 40 and 80 years old."

Answered by AI

Which individuals meet the eligibility criteria to partake in this experiment?

"This medical trial seeks 9000 individuals aged 40 to 80 years old with atherosclerotic cardiovascular disease (ASCVD). Patients must meet the following conditions: HbA1c ≥6.5% if on no medication or >6% if taking glucose-lowering medications; Type 2 diabetes based off clinical diagnosis; Secondary prevention cohort (at least 70%) age 40 to 80 and evidence of established ASCVD history, Primary prevention cohort (max 30%) age 60-80 plus at least 1 additional high risk feature like smoking combustible tobacco/marijuana, HbA1c≥8%, Stage 3a CKD eG"

Answered by AI

Who else is applying?

What site did they apply to?
Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Brendan M. Everett 2022. "PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05390892.
All > Diabetic Kidney Disease
~6000 spots leftby Apr 2028
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