Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT05577728
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- New use of semaglutide injection — DRUGNew use of semaglutide injection dispensing claim is used as the exposure.
- New initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) — DRUGNew initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) dispensing claim is used as the reference.
Study Details
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Key Dates
- Start date
- Jul 1, 2021
- Status verified
- Sep 2024
- Primary completion
- Oct 31, 2022
- Completion
- Oct 31, 2022
Study Design
- Enrollment
- 2,316 participants (actual)
Arms
- Arm: New use of semaglutide injectionExposure group
- Arm: New initiation of "standard of care"(SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) Reference group
Primary Outcome Measure
Long-term glycemic control defined as proportion of patients who will achieve an HbA1c of less than 7.0% (53.0 mmol/mol) [ Time Frame: At year 1 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | - |
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