Diabetes
Conditions
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.
Interventions
DRUGDapagliflozin
Dapagliflozin dispensing claim for any dose is exposure
DRUGDPP-4 inhibitor
DPP4 inhibitor dispensing claim for any dose is reference
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions. Eligible cohort entry dates: Market availability of dapagliflozin in the U.S. started on January 8, 2014. * For Marketscan and Medicare: Jan 8, 2014-Dec 31, 2017 (end of data availability). * For Optum: Jan 8, 2014-Mar 31, 2019 (end of data availability). Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures (including run-in) 2. Female or male aged ≥ 40 years 3. Diagnosed with T2DM 4. High Risk for CV event defined as having either established CV disease and/or multiple risk factors: \- Established CV Disease (See Appendix E for details) OR No known cardiovascular disease AND at least two cardiovascular risk factors in addition to T2DM, defined as: * Age \> 55 years in men and \> 60 in women AND presence of at least 1 of the following additional risk factors (see Appendix E for details) * Dyslipidemia * Hypertension * Tobacco use 5. WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose. * WOCBP must have a negative urine pregnancy test. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. * WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator. For inclusion in the optional genetic research, patients must fulfill the criterion specified in
Exclusion criteria
Patients should not meet any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of Stroke, MI, and Mortality | Through study completion (a median of 120-140 days) | Composite outcome of MI, stroke, and mortality - Please refer to uploaded protocol for full definition due to size limitations. |
Countries
United States
Outcome results
None listed