Status:
COMPLETED
Second-line Therapies for Patients With Type 2 Diabetes and Moderate Cardiovascular Disease Risk
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Type 2 Diabetes
Cardiac Disease
Eligibility:
All Genders
21+ years
Brief 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-ident...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for all Aims
- ≥ 21 years old.
- Diagnosis of Type 2 diabetes.
- Use of ≥ 1 study drug (GLP-1RA, SGLT2i, DPP-4i, SU).
- Exclusion Criteria for Aims 1, 2B, 3
- Fill for any study drug during the baseline period or simultaneous (within 30 days) start of ≥2 study drugs
- Insulin use
- Type 1 diabetes
- High risk of CVD
- Pregnancy
- Metastatic cancer
- Exclusion Criteria for Aim 2A
- Insulin use.
- Cognitive impairment.
- Terminal or advanced illness.
- Non-English speaking.
- Residency in a long-term care setting.
Exclusion
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2025
Estimated Enrollment :
386301 Patients enrolled
Trial Details
Trial ID
NCT05214573
Start Date
December 1 2021
End Date
July 22 2025
Last Update
October 10 2025
Active Locations (1)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905