Replication of the SEPRA Diabetes Trial in Healthcare Claims Data

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05577728

Collaborator

(none)

1,356

Enrollment

Location

Anticipated Duration (Months)

84.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	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)

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

1356 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Replication of the SEPRA Diabetes Trial in Healthcare Claims Data

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
New use of semaglutide injection Exposure group	Drug: New use of semaglutide injection 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) Reference group	Drug: New initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) 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.

Arm

Intervention/Treatment

New use of semaglutide injection

Exposure group

Drug: New use of semaglutide injection

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) Reference group

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

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.

Outcome Measures

Primary Outcome Measures

Long-term glycemic control defined as proportion of patients who will achieve an HbA1c of less than 7.0% (53.0 mmol/mol) [At year 1]
Number of subjects

Secondary Outcome Measures

Change in HbA1c [At 1 year]
Change in HbA1c from baseline at 365 days after drug initiation.
Number of hypoglycemic episodes leading to an inpatient admission or emergency room encounter. [At 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

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 - June 30, 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 >= 7% 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02120

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Oct 7, 2022

More Information

Publications

None provided.

Responsible Party:

Shirley Vichy Wang, Associate Professor of Medicine, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT05577728

Other Study ID Numbers:

DUPLICATE-SEPRA

First Posted:

Oct 13, 2022

Last Update Posted:

Oct 13, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Oct 13, 2022