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Combination Therapy for Type 2 Diabetes(PRECIDENTD Trial)

Vanderbilt University Medical Center, Nashville, TN
Targeting 2 different conditionsCombination drug +2 morePhase 4RecruitingResearch Sponsored by Brigham and Women's Hospital

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.

Eligible Conditions
  • Type 2 Diabetes
  • Cardiovascular Disease

PRECIDENTD Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with type 2 diabetes by a doctor.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

PRECIDENTD Trial Design

3Treatment groups
Active Control
Group I: 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)
Group II: 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 III: 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
1,565 Previous Clinical Trials
11,447,194 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
535 Previous Clinical Trials
29,949,230 Total Patients Enrolled

Media Library

Combination drug Clinical Trial Eligibility Overview. Trial Name: NCT05390892 — Phase 4
Type 2 Diabetes Research Study Groups: Combination SGLT2i and GLP-1 RA, 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

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 diabetesc 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
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 > Kidney Failure > Cardiovascular
~6000 spots leftby Apr 2028
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