Condition or disease | Intervention/treatment |
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Diabetes | Drug: Sitagliptin Drug: Sulfonylurea |
Study Type : | Observational |
Actual Enrollment : | 349476 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Replication of the TECOS Diabetes Trial in Healthcare Claims |
Actual Study Start Date : | September 22, 2017 |
Estimated Primary Completion Date : | September 22, 2020 |
Estimated Study Completion Date : | September 22, 2020 |
Group/Cohort | Intervention/treatment |
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2nd Generation SUs
Reference group
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Drug: Sulfonylurea
2nd generation sulfonylurea dispensing claim is used as the reference
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Sitagliptin
Exposure group
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Drug: Sitagliptin
Sitagliptin dispensing claim is used as the exposure
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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Inclusion Criteria:
Ischemic cerebrovascular disease, including:
Exclusion Criteria:
United States, Massachusetts | |
Brigham & Women's Hospital | |
Boston, Massachusetts, United States, 02120 |
Principal Investigator: | Jessica Franklin, PhD | Brigham and Womens |
Tracking Information | |||||
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First Submitted Date | April 29, 2019 | ||||
First Posted Date | May 3, 2019 | ||||
Last Update Posted Date | January 2, 2020 | ||||
Actual Study Start Date | September 22, 2017 | ||||
Estimated Primary Completion Date | September 22, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Relative hazard of composite outcome of ACS/unstable angina, Stroke, MI, and Mortality [ Time Frame: Through study completion (a median of 118 days) ] Relative hazard of composite outcome of ACS/unstable angina, MI, stroke, and mortality - Please refer to uploaded protocol for full definition due to size limitations.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Replication of the TECOS Diabetes Trial in Healthcare Claims | ||||
Official Title | Replication of the TECOS Diabetes Trial in Healthcare Claims | ||||
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. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | This study will involve a new user, parallel group, cohort study design comparing sitagliptin to the 2nd generation sulfonylurea antidiabetic class as a proxy for placebo, since this class of antidiabetic drugs is not known to have an impact on the outcome of interest. The patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of sitagliptin or a comparator drug (index date). Follow-up for the outcome (4P-MACE), begins the day after drug initiation. As in the trial, patients are allowed to take other antidiabetic medications during the study. Eligible cohort entry dates: 10/17/2006-12/31/2016 (market availability of sitagliptin in the U.S. started on 10/17/2006). For Optum, 10/17/2006-9/30/201. | ||||
Condition | Diabetes | ||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Franklin JM, Patorno E, Desai RJ, Glynn RJ, Martin D, Quinto K, Pawar A, Bessette LG, Lee H, Garry EM, Gautam N, Schneeweiss S. Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies: First Results From the RCT DUPLICATE Initiative. Circulation. 2021 Mar 9;143(10):1002-1013. doi: 10.1161/CIRCULATIONAHA.120.051718. Epub 2020 Dec 17. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Actual Enrollment |
349476 | ||||
Original Actual Enrollment |
287346 | ||||
Estimated Study Completion Date | September 22, 2020 | ||||
Estimated Primary Completion Date | September 22, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions. Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03936062 | ||||
Other Study ID Numbers | DUPLICATE-TECOS | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Jessica Franklin, Brigham and Women's Hospital | ||||
Study Sponsor | Brigham and Women's Hospital | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Brigham and Women's Hospital | ||||
Verification Date | December 2019 |