Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data

Mass General Brigham

Status: Completed

Conditions: Diabetes Mellitus, Type 2

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

Study type: Observational

Funder types: Other

Identifiers

NCT05577728

2018P002966-DUP-SEPRA

Details and patient eligibility

About

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.

Full description

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Enrollment: 2,316 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,316 participants in 2 patient groups

New use of semaglutide injection

Description:

Exposure group

Treatment:

Drug: New use of semaglutide injection

New initiation of "standard of care"

Description:

(SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) Reference group

Treatment:

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