A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease
NCT ID: NCT03936660
Last Updated: 2024-11-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1049 participants
INTERVENTIONAL
2019-07-25
2022-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of LY3305677 in Participants With Type 2 Diabetes
NCT03928379
Chronicare for Type 2 Diabetes (Chronicare-T2D)
NCT03997331
CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
NCT06783309
A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus
NCT02091362
Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes
NCT01364584
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients must be enrolled during a routine visit in a cardiology clinic, and the clinic must have at least 3 physicians and/or APPs on staff with independent patient populations.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Clinics provided with existing clinical care guidelines.
No interventions assigned to this group
Intervention
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.
Intense Education Intervention
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intense Education Intervention
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of Type 2 diabetes mellitus (T2DM)
* History of at least one of the following conditions:
1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
2. Stroke and/or carotid artery stenosis (≥50%)
3. 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Eli Lilly and Company
INDUSTRY
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher Granger, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Grandview Health/Alabama Cardiovascular Group
Birmingham, Alabama, United States
USA Cardiology
Mobile, Alabama, United States
Alaska Heart and Vascular Institute
Anchorage, Alaska, United States
Dignity Health/DHMG Specialty Medicine
Phoenix, Arizona, United States
Stanford University
Stanford, California, United States
Blue Coast Cardiology
Vista, California, United States
Aurora Denver Cardiology
Denver, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Orlando Heart and Vascular Institute
Altamonte Springs, Florida, United States
Riverside Medical Center/Synergy Healthcare
Bradenton, Florida, United States
Lennar Foundation/Univ. of Miami
Coral Gables, Florida, United States
Citrus Cardiology
Inverness, Florida, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
Advanced Research for Health Improvement, LLC
Naples, Florida, United States
Cardiovascular Inst. of Northwest Florida
Panama City, Florida, United States
Bayfront Cardiovascular Associates
St. Petersburg, Florida, United States
Interventional Cardiac Consultants
Trinity, Florida, United States
Emory/Grady Memorial Hospital
Atlanta, Georgia, United States
Advocate Heart Institute
Chicago, Illinois, United States
Advanced Heart Care Group/Medicoricium LLC
Fairview Heights, Illinois, United States
Specialty Physicians of Illinois
Olympia Fields, Illinois, United States
UnityPoint Health Cardiovascular Services
Peoria, Illinois, United States
Prairie Cardiovascular Consultants
Springfield, Illinois, United States
Iowa Heart Center
Des Moines, Iowa, United States
Heart Clinic of Louisiana
Marrero, Louisiana, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Endeavor Medical Research
Alpena, Michigan, United States
Cardiology Institute of Michigan
Flint, Michigan, United States
Hannibal Regional Medical Group
Hannibal, Missouri, United States
Advanced Heartcare LLC
Bridgewater, New Jersey, United States
New Jersey Heart
Linden, New Jersey, United States
Garden State Heart Care
Manalapan, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States
Northwell Health/Lenox Hill Hospital
Manhasset, New York, United States
Kernodle Clinic
Burlington, North Carolina, United States
Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch
Greensboro, North Carolina, United States
Cape Fear Heart Associates
Wilmington, North Carolina, United States
Cardiovascular Health Clinic
Oklahoma City, Oklahoma, United States
Guthrie Medical Group
Sayre, Pennsylvania, United States
Advanced Cardiology Associates
Greenwood, South Carolina, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, United States
Univ. of Texas Southwestern
Dallas, Texas, United States
Lonestar Heart and Vascular
Tomball, Texas, United States
ProHealth Care Heart and Vascular
Waukesha, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00101556
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.