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Completed

Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data

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

NCT IDNCT05577728
Org study ID2018P002966-DUP-SEPRA

Timeline

Milestones

Study start2021-07-01actual
Study first posted2022-10-13actual
Primary completion2022-10-31actual
Study completion2022-10-31actual
Last update posted2024-09-25actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

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:

For Optum: December 6, 2017 - May 31, 2021 (end of data availability)

Inclusion Criteria:

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

Exclusion criteria

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

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
Safety / tolerability / PK
1

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

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

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:At 1 year

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.