Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data
1 other identifier
observational
2,316
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedSeptember 25, 2024
September 1, 2024
1.3 years
October 10, 2022
September 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Long-term glycemic control defined as proportion of patients who will achieve an HbA1c of less than 7.0% (53.0 mmol/mol)
Number of subjects
At year 1
Secondary Outcomes (2)
Change in HbA1c
At 1 year
Number of hypoglycemic episodes leading to an inpatient admission or emergency room encounter.
At 1 year
Study Arms (2)
New use of semaglutide injection
Exposure group
New initiation of "standard of care"
(SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) Reference group
Interventions
New 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) dispensing claim is used as the reference.
Eligibility Criteria
Patients with type 2 diabetes who have previously been treated with metformin.
You may qualify if:
- Age \>= 18
- Type 2 diabetes mellitus diagnosis
- Use of metformin
- At least 2 HbA1c records within the prior 280 days
- At least 1 HbA1c record within the prior 90 days
You may not qualify if:
- Missing age or gender
- Use of any other anti-diabetes medications
- Any insulin use
- Pregnancy
- Multiple Endocrine Neoplasia syndrome type 2
- CKD stage 5, ESRD, dialysis, or renal transplant
- Nursing home admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
Related Publications (1)
Kattinakere Sreedhara S, Schneeweiss S, D'Andrea E, Weberpals JG, DiCesare EC, Patorno E, Tsacogianis T, Bradley M, Concato J, Wang SV. Using real-world data to predict findings of an ongoing phase IV trial: glycemic control of semaglutide versus standard of care. BMJ Open Diabetes Res Care. 2025 Oct 29;13(5):e005180. doi: 10.1136/bmjdrc-2025-005180.
PMID: 41161770DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shirley Wang, PhD, ScM
Brigham and Women's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
October 10, 2022
First Posted
October 13, 2022
Study Start
July 1, 2021
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
September 25, 2024
Record last verified: 2024-09