An observational study in Diabetes, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. 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 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 through 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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 3,474 is above the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will involve a new user, parallel group, propensity score-matched, retrospective cohort design comparing injectable subcutaneous liraglutide (1.2 or 1.8 mg/day) to oral glimepiride (4 mg once daily). Treatments in both arms are administered in combination with metformin (up to 2,000 mg/day). Patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of liraglutide or glimepiride. The analyses will be restricted to individuals with type 2 diabetes mellitus who have been previously treated with antidiabetic drugs. In the replication, previous anti-diabetic treatment was defined as the presence of at least 2 prescriptions for metformin within 6 months before and including cohort entry.
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Exclusion Criteria:
Reference Group
Drug: Glimepiride
Exposure group
Drug: Liraglutide
Glimepiride dispensing claim is used as the reference group.
Liraglutide dispensing claim is used as the exposure group.
Relative Hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up)
Claims-based algorithm: relative hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up)
Time frame: 26-week follow-up window with a median follow-up time of 99 [84, 148] days
Documents are hosted by the registry — open the source record to download them.
Ran from Sep 2019 to primary completion in Sep 2021, 24 months.
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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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