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Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data
Lead sponsor
Asset
Semaglutide
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
2,316
actual
Study population
Type 2 diabetes
Key I/E criterion
—
Primary endpoint
•HbA1c <7.0% achievement
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Study population text
Patients with type 2 diabetes who have previously been treated with metformin.
Inclusion criteria
All patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of semaglutide or standard of care (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) (cohort entry).
Eligible cohort entry dates:
Market availability of semaglutide/standard of care in the US started on December 6th, 2017:
Inclusion Criteria:
Exclusion criteria
Endpoints (3)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
2 endpointsLong-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
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Change in HbA1c
Time frame:At 1 year
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Safety / tolerability / PK
1 endpointNumber of hypoglycemic episodes leading to an inpatient admission or emergency room encounter.
Time frame:At 1 year
event count, event
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- BMJ open diabetes research & care2025 Oct 29PMID41161770doi:10.1136/bmjdrc-2025-005180via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.