Replication of the SEPRA Diabetes Trial in Healthcare Claims Data
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: 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)
- Registration Number
- NCT05577728
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2316
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description New use of semaglutide injection New use of semaglutide injection Exposure group New initiation of "standard of care" New initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) Reference group
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of hypoglycemic episodes leading to an inpatient admission or emergency room encounter. At 1 year Change in HbA1c At 1 year Change in HbA1c from baseline at 365 days after drug initiation.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States