An observational study in Diabetes, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Brigham and Women's Hospital · Observational
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 6,403 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with type 2 diabetes who have previously been treated with metformin.
Exclusion Criteria:
Reference group
Drug: Sitagliptin
Exposure group
Drug: Glimepiride
Sitagliptin dispensing claim is used as the reference
Glimepiride dispensing claim is used as the reference
Time until failure to maintain metabolic control
Lab based algorithm: time until failure to maintain metabolic control (HbA1c level \>= 7.0% or 53 mmol/mol)
Time frame: Through censoring or study completion, up to 765 days after cohort entry
Time until a severe hypoglycemic episode
Claims based algorithm: time until a severe hypoglycemic episode
Time frame: Through censoring or study completion, up to 765 day after cohort entry
HbA1C change from baseline
Lab based algorithm: HbA1C change from baseline
Time frame: Through censoring or study completion, up to 765 days after cohort entry
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital