Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05214573 |
| Other study ID # |
21-007688 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
April 2025 |
Study information
| Verified date |
September 2023 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Study Design: We will use the target trial framework for causal inference to conduct this
observational cohort study.
Comparators: Aims 1-2 compare the GLP-1RA, SGLT2i, DPP-4i, and SU classes, while Aim 3
compares the individual drugs within each therapeutic class.
Population: Using data from OptumLabs Data Warehouse linked to 100% Medicare FFS claims, we
will identify adults (≥21 years) with T2D at moderate risk for CVD who started a GLP-1RA,
SGLT2i, DPP-4i, or SU
Outcomes: In AIMs 1 and 3, the primary outcome will be time to MACE (non-fatal MI, non-fatal
stroke, all-cause mortality). Secondary outcomes will include times to expanded MACE (MACE,
HF hospitalizations, revascularization procedures) and its components, lower extremity
complications, severe hypoglycemia, microvascular complications, and other significant
adverse events. In AIM 2A, we will elicit patient preferences toward various treatment
outcomes using a participatory ranking exercise, use these rankings to generate individually
weighted composite outcomes, and then estimate patient-centered treatment effects of GLP-1RA,
SGLT2i, DPP4i, and SU reflecting the patient values for each of the outcomes.
Timeframe: January 1, 2014 to December 31, 2021.
Methods: Inverse probability weighting will be used to emulate baseline randomization for
pairwise comparisons between the drug classes (AIMs 1-2) and individual drugs within each
class (AIM 3). Causal cumulative incidence rates will be estimated in the weighted sample
using the targeted maximum likelihood estimator adjusting for time-dependent confounding and
loss-to-follow-up.
