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Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk

NCT05214573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 386301

Last updated 2025-10-10

Study results available
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Summary

We will use the target trial framework for causal inference to conduct this observational retrospective cohort study that uses claims data of adults with type 2 diabetes (T2D) included in the de-identified datasets of OptumLabs Data Warehouse (OLDW) and Medicare fee-for-service.

In Aim 1, we will emulate a target trial comparing the effectiveness of glucagon-like peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter 2 inhibitors (SGLT2i), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU) in adults with T2D at moderate risk of cardiovascular disease (CVD) with regard to major adverse cardiovascular events (MACE), expanded MACE, microvascular complications, severe hypoglycemia, and other adverse events.

In Aim 2, we will compare these four drug classes in the same population of adults with T2D included in OLDW and Medicare fee-for-service data with respect to a set of composite outcomes identified by a group of patients with T2D as being most important to them. Specifically, in Aim 2A, we will prospectively elicit patient preferences toward various treatment outcomes (e.g., hospitalization, kidney disease) using a participatory ranking exercise, then use these rankings to generate individually weighted composite outcomes. Then, in Aim 2B, we will estimate patient-centered treatment effects of four different second-line T2D medications that reflect the patient's value for each outcome.

In Aim 3, we will compare different medications within each of the four therapeutic classes with respect to MACE.

Conditions

Interventions

DRUG

Glucagon like peptide 1 receptor agonist

Patients in the data who filled a glucagon-like peptide-1 receptor agonist medication

DRUG

Sodium-glucose cotransporter 2 inhibitor

Patients in the data who filled a sodium-glucose cotransporter 2 inhibitor

DRUG

Dipeptidyl Peptidase 4 Inhibitor

Patients in the data who filled a dipeptidyl peptidase-4 inhibitor

DRUG

Sulfonylurea

Patients in the data who filled a sulfonylurea

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Rozalina McCoy, MD, MS · Mayo Clinic

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-09-30
Completion
2025-07-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05214573 on ClinicalTrials.gov