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

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 injection
    Exposure 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)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

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