Suspended

Supporting Guideline-recommended SGLT2i and GLP-1 RA Medications for Patients with Comorbid T2DM and ASCVD

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to determine the percentage of individuals with Type 2 Diabetes Mellitus (T2DM) and Atherosclerotic Cardiovascular Disease (ASCVD) who start using SGLT2 inhibitor (SGLT2i) or Glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications, which offer cardiovascular benefits, as recommended by guidelines.

What is being tested

Educational Intervention

Other
Who is being recruted

Cardiovascular Diseases+4

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 85 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: August 2021
See protocol details

Summary

Principal SponsorHumana Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 18, 2021

Actual date on which the first participant was enrolled.

This study focuses on improving the health of individuals who have both type 2 diabetes mellitus (T2DM) and a history of atherosclerotic cardiovascular disease (ASCVD), and who have not used certain recommended medications in the past year. The goal is to help these patients manage their conditions better. The study identifies primary care providers and assigns them randomly to either an intervention group or a control group. All eligible patients under the care of these providers are included. Specialist providers, such as cardiologists and endocrinologists, are also identified and contacted. The importance of this study lies in its potential to enhance patient care by promoting the use of guideline-recommended medications, potentially reducing cardiovascular risk. The study involves a multi-faceted approach to support providers in caring for their patients. This includes sharing recent treatment recommendations based on guidelines and providing patients with information on reducing their cardiovascular risk. The study does not require active enrollment or recruitment. The primary outcome measured is the percentage of individuals with T2DM and ASCVD who start using SGLT2i or GLP-1 RA medications. These medications have cardiovascular benefits, excluding combination products. This is determined by reviewing administrative claims data for pharmacy claims.

Official TitleImproving Outcomes in Patients With Comorbid T2DM and ASCVD: Population Health Management Interventions Supporting Guideline-recommended SGLT2i and GLP-1 RA Medications
Principal SponsorHumana Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4197 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

Inclusion Criteria: Patient * Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM * ≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification * Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date * Age 18-85 years at time of identification * Patients residing in Kentucky (KY), West Virginia (WV), Pennsylvania (PA), and 6 counties in south New Jersey (NJ) (Burlington, Camden, Cumberland, Gloucester, Mercer, Salem) (United States) Provider * Primary care providers of the identified patients Exclusion Criteria: Patients * ≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure * Any hospice or long-term care residence * ≥1 code for pregnancy/childbirth * Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period * Patients without an attributed primary care provider * Patients on do not contact lists * Patients without valid addresses and telephone numbers * Patients with ≥1 diagnosis for type 1 diabetes pre-identification Primary care providers * Providers on do not contact lists * Providers without valid fax/mailing address and phone number * Providers with \<3 or \>50 eligible patients

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The educational outreach intervention will entail a multi-faced strategy to provide patients resources to learn more about reducing their risk for heart disease and supporting providers in the care of their patients by sharing recent guideline-recommended treatments for these high-risk individuals.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Humana

Louisville, United StatesOpen Humana in Google Maps
SuspendedOne Study Center