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PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes (PRECIDENTD)

Primary Purpose

Type2Diabetes, ASCVD

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

SGLT2 inhibitor

GLP-1 receptor agonist

Combination drug

About this trial

This is an interventional prevention trial for Type2Diabetes

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 2 diabetes based on clinical diagnosis
HbA1c ≥6.5% if on no medication or >6% if on glucose-lowering medication, measured within 6 months prior to screening
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).
Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety
Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider.
If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes or to combination therapy
Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities

Exclusion Criteria:

Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)
Use of prandial or short-acting insulin in combination with basal insulin
History of diabetic ketoacidosis
Active diabetic foot ulcer
History of pancreatitis
Heart failure as a primary reason for hospitalization within the past year OR known left ventricular ejection fraction <40%
Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2
Known inability to afford study medication through current insurance coverage.
If a woman of child-bearing potential, patient, or partner unwilling to use birth control

Sites / Locations

Johns Hopkins School of MedicineRecruiting
University of Missouri-ColumbiaRecruiting
Naomi Berrie Diabetes Center at New York Presbyterian-Columbia UniversityRecruiting
Duke University HospitalRecruiting
Medical University of South CarolinaRecruiting
Vanderbilt University Medical CenterRecruiting
Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Sodium-glucose cotransporter-2 inhibitor (SGLT2i)

Glucagon-like peptide-1 receptor agonist (GLP-1 RA)

Combination SGLT2i and GLP-1 RA

Arm Description

Therapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin

Therapy with a GLP-1 RA with proven cardiovascular benefit. This means either dulaglutide, liraglutide, or semaglutide.

Combination therapy with an SLGT2i (canagliflozin, dapagliflozin, or empagliflozin) AND a GLP-1 RA (dulaglutide, liraglutide, or semaglutide)

Outcomes

Primary Outcome Measures

Total (first and recurrent) cardiovascular, kidney, and death events

total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT05390892

First Posted

May 19, 2022

Last Updated

July 25, 2023

Sponsor

Brigham and Women's Hospital

Collaborators

Patient-Centered Outcomes Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05390892

Brief Title

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Acronym

PRECIDENTD

Official Title

PRECIDENTD: PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 26, 2022 (Actual)

Primary Completion Date

April 30, 2028 (Anticipated)

Study Completion Date

April 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

PRECIDENTD is a randomized, open label, pragmatic clinical trial 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. To accomplish this objective, we will randomly assign 9,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1:1 allocation to SGLT2i, GLP-1RA, or the combination. Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2Diabetes, ASCVD

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sodium-glucose cotransporter-2 inhibitor (SGLT2i)

Arm Type

Active Comparator

Arm Description

Therapy with an SGLT2i with proven cardiovascular benefit. This means either canagliflozin, dapagliflozin, or empagliflozin

Arm Title

Glucagon-like peptide-1 receptor agonist (GLP-1 RA)

Arm Type

Active Comparator

Arm Description

Therapy with a GLP-1 RA with proven cardiovascular benefit. This means either dulaglutide, liraglutide, or semaglutide.

Arm Title

Combination SGLT2i and GLP-1 RA

Arm Type

Active Comparator

Arm Description

Combination therapy with an SLGT2i (canagliflozin, dapagliflozin, or empagliflozin) AND a GLP-1 RA (dulaglutide, liraglutide, or semaglutide)

Intervention Type

Drug

Intervention Name(s)

SGLT2 inhibitor

Intervention Description

Empagliflozin, dapagliflozin, or canagliflozin

Intervention Type

Drug

Intervention Name(s)

GLP-1 receptor agonist

Intervention Description

Dulaglutide, liraglutide, semaglutide

Intervention Type

Drug

Intervention Name(s)

Combination drug

Intervention Description

SGLT2 inhibitor and GLP-1 receptor agonist

Primary Outcome Measure Information:

Title

Total (first and recurrent) cardiovascular, kidney, and death events

Description

Time Frame

Through study completion on May 1, 2028, an average of 3 years of follow up for each participant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 diabetes based on clinical diagnosis HbA1c ≥6.5% if on no medication or >6% if on glucose-lowering medication, measured within 6 months prior to screening 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). Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider. If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes or to combination therapy Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities Exclusion Criteria: Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.) Use of prandial or short-acting insulin in combination with basal insulin History of diabetic ketoacidosis Active diabetic foot ulcer History of pancreatitis Heart failure as a primary reason for hospitalization within the past year OR known left ventricular ejection fraction <40% Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m2 Known inability to afford study medication through current insurance coverage. If a woman of child-bearing potential, patient, or partner unwilling to use birth control

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brendan Everett, MD, MPH

Phone

617-732-8790

PRECIDENTDccc@bwh.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Maureen Malloy

Phone

617-732-8773

PRECIDENTDccc@bwh.harvard.edu

Facility Information:

Facility Name

Johns Hopkins School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dan Shelton

Phone

443-653-3239

PRECIDENTD@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Rita Kalyani, MD

First Name & Middle Initial & Last Name & Degree

Jodi Segal, MD

First Name & Middle Initial & Last Name & Degree

Dan Ford, MD

Facility Name

University of Missouri-Columbia

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65211

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tea Goletiani

Phone

833-970-0046

MUPRECIDENTD@health.missouri.edu

First Name & Middle Initial & Last Name & Degree

Camilla Manrique A, MD

First Name & Middle Initial & Last Name & Degree

Guido Lastra, MD

Facility Name

Naomi Berrie Diabetes Center at New York Presbyterian-Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacqueline Lonier, MD

Phone

212-851-5428

jyl2122@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Jacqueline Lonier, MD

First Name & Middle Initial & Last Name & Degree

Robin Goland, MD

Facility Name

Duke University Hospital

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chad Harrell

Phone

919-668-9049

DukePRECIDENTD@duke.edu

First Name & Middle Initial & Last Name & Degree

W. Schuyler Jones, MD

First Name & Middle Initial & Last Name & Degree

Ranee Chatterjee, MD

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elizabeth Szwast

Phone

843-792-4675

hinsone@musc.edu

First Name & Middle Initial & Last Name & Degree

Harsha Karanchi, MD

First Name & Middle Initial & Last Name & Degree

Marc Cornier, MD

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lance Roller

Phone

615-875-6811

Lance.j.roller@vumc.org

First Name & Middle Initial & Last Name & Degree

Leslee Matheny, MD

First Name & Middle Initial & Last Name & Degree

Russell Rothman, MD

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberta Fritz-Claus

Phone

414-805-0634

rfritzclaus@mcw.edu

First Name & Middle Initial & Last Name & Degree

Jake Decker, MD

First Name & Middle Initial & Last Name & Degree

Jeffrey Whittle, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

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