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Trial · Observational

CompletedPhase not statedRegistry data

Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data

NCTNCT05577728 (opens ClinicalTrials.gov in a new tab)Other id2018P002966-DUP-SEPRA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
2,316 participants (actual)
Sponsor
Brigham and Women's Hospital · Other
Design
Not stated
Countries
1 country

United States

Start
1 Jul 2021
Primary completion
31 Oct 2022
Completion
31 Oct 2022
First posted
13 Oct 2022
Last update posted
25 Sept 2024
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph –

    Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data

    NCT05577728

    1 Jul 2021 to 31 Oct 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • New use of semaglutide injectionDrug
  • New initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral)Drug

Arms2

  • Other

    New use of semaglutide injection

    Exposure group

  • Other

    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 outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    Number of subjects

Secondary outcomes(2)

  1. Change in HbA1c

    Time frame · At 1 year

    Registry description

    Change in HbA1c from baseline at 365 days after drug initiation.

  2. Number of hypoglycemic episodes leading to an inpatient admission or emergency room encounter.

    Time frame · At 1 year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2025

2 results

Using real-world data to predict findings of an ongoing phase IV trial: glycemic control of semaglutide versus standard of care.

Kattinakere Sreedhara et al. 2025BMJ open diabetes research & care

PMID 41161770PMC12574359DOI 10.1136/bmjdrc-2025-005180PUB-41161770

CC BY2 results
Download PDFSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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