A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease

NCT03936660 | Completed Results DMC

• 1 other identifier: Pro00101556
• Study Type: interventional
• Target: 1,049
• Locations: 1 country
• Sites: 44

Brief Summary

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

COORDINATE-DIABETES; COORDINATE; T2DM; Diabetes Mellitus, Type 2; Cardiovascular Disease; Prevention

Outcome Measures

Primary Outcomes (1)

• Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications

  Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c \< 7%.

  Up to 12 Months

Secondary Outcomes (9)

• Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.

  Up to 12 Months

• Change in Average LDL-C From Baseline to Last Follow-up Visit.

  Baseline and last follow-up visit (up to 12 months)

• Number of Participants With LDL-C < 70 mg/dL

  Baseline and last follow-up visit (up to 12 months)

• Change in Average Blood Pressure From Baseline to Last Follow-up Visit.

  Baseline and last follow-up visit (up to 12 months)

• Number of Participants With sBP < 130 mmHg

  Baseline and last follow-up visit (up to 12 months)

Study Arms (2)

Control

NO INTERVENTION

Clinics provided with existing clinical care guidelines.

Intervention

ACTIVE COMPARATOR

Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.

Other: Intense Education Intervention

Interventions

Intense Education Intervention OTHER

Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.

Also known as: Intervention

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Diagnosis of Type 2 diabetes mellitus (T2DM)
• History of at least one of the following conditions:
• Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
• Stroke and/or carotid artery stenosis (≥50%)
• Peripheral Arterial disease (defined as claudication with ABI\<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)
• Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization

You may not qualify if:

• Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator
• GFR\<30 mL/min/1.73m2
• Already on all guideline-recommended therapies for T2DM and CVD
• Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD

Sponsors & Collaborators

• Duke University: lead
• Boehringer Ingelheim: collaborator
• Eli Lilly and Company: collaborator

Study Sites (44)

Grandview Health/Alabama Cardiovascular Group

Birmingham, Alabama, 35243, United States

Location

USA Cardiology

Mobile, Alabama, 36617, United States

Location

Alaska Heart and Vascular Institute

Anchorage, Alaska, 99508, United States

Location

Dignity Health/DHMG Specialty Medicine

Phoenix, Arizona, 85013, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Blue Coast Cardiology

Vista, California, 92083, United States

Location

Aurora Denver Cardiology

Denver, Colorado, 80012, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Orlando Heart and Vascular Institute

Altamonte Springs, Florida, 32714, United States

Location

Riverside Medical Center/Synergy Healthcare

Bradenton, Florida, 34208, United States

Location

Lennar Foundation/Univ. of Miami

Coral Gables, Florida, 33146, United States

Location

Citrus Cardiology

Inverness, Florida, 34452, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32258, United States

Location

Advanced Research for Health Improvement, LLC

Naples, Florida, 34102, United States

Location

Cardiovascular Inst. of Northwest Florida

Panama City, Florida, 32401, United States

Location

Bayfront Cardiovascular Associates

St. Petersburg, Florida, 33701, United States

Location

Interventional Cardiac Consultants

Trinity, Florida, 34655, United States

Location

Emory/Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Advocate Heart Institute

Chicago, Illinois, 60657, United States

Location

Advanced Heart Care Group/Medicoricium LLC

Fairview Heights, Illinois, 62208, United States

Location

Specialty Physicians of Illinois

Olympia Fields, Illinois, 60461, United States

Location

UnityPoint Health Cardiovascular Services

Peoria, Illinois, 61606, United States

Location

Prairie Cardiovascular Consultants

Springfield, Illinois, 62701, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50266, United States

Location

Heart Clinic of Louisiana

Marrero, Louisiana, 70072, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Endeavor Medical Research

Alpena, Michigan, 49707, United States

Location

Cardiology Institute of Michigan

Flint, Michigan, 48507, United States

Location

Hannibal Regional Medical Group

Hannibal, Missouri, 63401, United States

Location

Advanced Heartcare LLC

Bridgewater, New Jersey, 08807, United States

Location

New Jersey Heart

Linden, New Jersey, 07036, United States

Location

Garden State Heart Care

Manalapan, New Jersey, 07726, United States

Location

Cardiovascular Associates of the Delaware Valley

Sewell, New Jersey, 08080, United States

Location

Northwell Health/Lenox Hill Hospital

Manhasset, New York, 11030, United States

Location

Kernodle Clinic

Burlington, North Carolina, 27215, United States

Location

Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch

Greensboro, North Carolina, 27401, United States

Location

Cape Fear Heart Associates

Wilmington, North Carolina, 28401, United States

Location

Cardiovascular Health Clinic

Oklahoma City, Oklahoma, 73134, United States

Location

Guthrie Medical Group

Sayre, Pennsylvania, 18840, United States

Location

Advanced Cardiology Associates

Greenwood, South Carolina, 29646, United States

Location

Black Hills Cardiovascular Research

Rapid City, South Dakota, 57701, United States

Location

Univ. of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Lonestar Heart and Vascular

Tomball, Texas, 77375, United States

Location

ProHealth Care Heart and Vascular

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (8)

• Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1094. doi: 10.1056/NEJMc1600827. No abstract available.

  PMID: 26981940 BACKGROUND

• Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

  PMID: 27295427 BACKGROUND

• Sattar N, Petrie MC, Zinman B, Januzzi JL Jr. Novel Diabetes Drugs and the Cardiovascular Specialist. J Am Coll Cardiol. 2017 May 30;69(21):2646-2656. doi: 10.1016/j.jacc.2017.04.014.

  PMID: 28545639 BACKGROUND

• Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB; IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737-1746. doi: 10.1016/S0140-6736(17)32165-7. Epub 2017 Aug 28.

  PMID: 28859942 BACKGROUND

• American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009.

  PMID: 30559235 BACKGROUND

• American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S103-S123. doi: 10.2337/dc19-S010.

  PMID: 30559236 BACKGROUND

• Tannu M, Kaltenbach L, Pagidipati NJ, McGuire DK, Aroda VR, Pop-Busui R, Kondamudi N, Al-Khalidi HR, Lopes RD, Cavender MA, Nelson AJ, Kirk J, Lingvay I, Magwire M, Richardson CR, Webb L, Leyva M, Pandey A, Washington A, Pak J, Gaynor T, Khan W, Weston P, Granger CB, Green J. Effects of an Intervention to Improve Evidence-Based Care for People With Diabetes and Cardiovascular Disease Across Sex, Race, and Ethnicity Subgroups: Insights From the COORDINATE-Diabetes Trial. Circulation. 2024 Jul 16;150(3):180-189. doi: 10.1161/CIRCULATIONAHA.124.068962. Epub 2024 Jun 27.

  PMID: 38934111 DERIVED

• Pagidipati NJ, Nelson AJ, Kaltenbach LA, Leyva M, McGuire DK, Pop-Busui R, Cavender MA, Aroda VR, Magwire ML, Richardson CR, Lingvay I, Kirk JK, Al-Khalidi HR, Webb L, Gaynor T, Pak J, Senyucel C, Lopes RD, Green JB, Granger CB; COORDINATE-Diabetes Site Investigators. Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2023 Apr 18;329(15):1261-1270. doi: 10.1001/jama.2023.2854.

  PMID: 36877177 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Chris Granger, MD
• Organization: Duke Clinical Research Institute

christopher.granger@duke.edu

9196688700

Study Officials

• Christopher Granger, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: July 25, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (44)