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NCT05214573 · ClinicalTrials.gov registry record
Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 386,301
- Enrollment target
NCT05214573: Completed study, sponsored by Mayo Clinic.
NCT05214573 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 386,301 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05214573 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 386,301 participants
- Enrollment target
Study 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.
Primary Outcome
The probability of 3-point MACEs experienced by subjects treated with DPP4i, GLP-1RA, SGLT2i, or Sulfonylureas (SU) defined as non-fatal myocardial infarction (MI), non-fatal stroke, and mortality. The probability was calculated and reported as the hazard ratio.
Interventions
- DRUG Sulfonylurea
- DRUG Glucagon like peptide 1 receptor agonist
- DRUG Sodium-glucose cotransporter 2 inhibitor
- DRUG Dipeptidyl Peptidase 4 Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386,301 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2025-07-22 |
What the finished NCT05214573 record still lists
NCT05214573 is an observational study that tracks outcomes without assigning an intervention. Its 386,301 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 4 interventions - of which Sulfonylurea is the first listed.
NCT05214573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05214573 about?
NCT05214573 is a clinical study titled "Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk". 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 e...
What is the current status of trial NCT05214573?
This trial is currently completed. The enrollment target is 386,301 participants. The study started on 2021-12-01. Estimated completion is 2025-07-22.
What interventions are being tested in trial NCT05214573?
The interventions under investigation include: Sulfonylurea (DRUG), Glucagon like peptide 1 receptor agonist (DRUG), Sodium-glucose cotransporter 2 inhibitor (DRUG), Dipeptidyl Peptidase 4 Inhibitor (DRUG).
Who is sponsoring clinical trial NCT05214573?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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