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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New use of semaglutide injection | Exposure group |
| |
| New initiation of "standard of care" | (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) Reference group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New use of semaglutide injection | Drug | New use of semaglutide injection dispensing claim is used as the exposure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term glycemic control defined as proportion of patients who will achieve an HbA1c of less than 7.0% (53.0 mmol/mol) | Number of subjects | At year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from baseline at 365 days after drug initiation. | At 1 year |
| Number of hypoglycemic episodes leading to an inpatient admission or emergency room encounter. | At 1 year |
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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:
Inclusion Criteria:
Exclusion Criteria:
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Patients with type 2 diabetes who have previously been treated with metformin.
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| Name | Affiliation | Role |
|---|---|---|
| Shirley Wang, PhD, ScM | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41161770 | Derived | Kattinakere Sreedhara S, Schneeweiss S, D'Andrea E, Weberpals JG, DiCesare EC, Patorno E, Tsacogianis T, Bradley M, Concato J, Wang SV. Using real-world data to predict findings of an ongoing phase IV trial: glycemic control of semaglutide versus standard of care. BMJ Open Diabetes Res Care. 2025 Oct 29;13(5):e005180. doi: 10.1136/bmjdrc-2025-005180. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan | Oct 7, 2022 | Oct 7, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| New initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) | Drug | 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. |
|
| D004700 | Endocrine System Diseases |