Clinical trial NCT05577728: Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data
Official title: Prediction of the SEPRA Diabetes Trial in Healthcare Claims Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 2316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes who have previously been treated with metformin.

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.

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.

Eligibility 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

Primary outcomes:
measure: Long-term glycemic control defined as proportion of patients who will achieve an HbA1c of less than 7.0% (53.0 mmol/mol)
timeFrame: At year 1
Secondary outcomes:
measure: Change in HbA1c
timeFrame: At 1 year
measure: Number of hypoglycemic episodes leading to an inpatient admission or emergency room encounter.
timeFrame: At 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shirley Wang, PhD, ScM
role: PRINCIPAL_INVESTIGATOR
References: