- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03936049
Recruitment Status Active, not recruiting
First Posted May 3, 2019
Last update posted January 2, 2020
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.
Liraglutide dispensing claim is used as the exposure group
|: DPP-4 inhibitor
Drug: DPP-4 inhibitor
DPP-4 inhibitor dispensing claim is used as the reference group
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for
full code and algorithm definitions.
Eligible cohort entry dates Market availability of liraglutide in the U.S. started on
January 20, 2010. For Marketscan and Medicare: January 20, 2010-Dec 31, 2016 (end of data
For Optum: January 20, 2010-Sep 30, 2017 (end of data availability).
- Men or women with type 2 diabetes
- Either of the following:
- Prior cardiovascular disease cohort: Age ≥ 50 years at screening, AND at least
one of the following:
- Prior MI
- Prior stroke or TIA
- Prior coronary, carotid or peripheral arterial revascularization
- >50% stenosis of coronary, carotid, or lower extremity arteries coded by
Peripheral vascular disease
- Chronic heart failure NYHA class II-III
- CKD stage 3-6 as Chronic renal failure:
- No Prior cardiovascular disease group: Age ≥ 60 years at screening, AND at least one
of the following:
- Microalbuminuria or proteinuria
- Hypertension and left ventricular hypertrophy by ECG or imaging
- Ankle-brachial index <0.9 Exclusion Criteria: - Type 1 diabetes - Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any (dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening - Use of long-term insulin in 90 days prior - Diabetic ketoacidosis in 3 months prior to index date as Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g., diabetic ketoacidosis) in the previous 3 months - Inpatient (hospitalization) code for MI, stroke, revascularization, PTCA, CABG IN PRIOR 14 DAYS as An acute coronary or cerebrovascular event in the previous 14 days - inpatient Heart failure (CHF) as Chronic heart failure NYHA class IV - ESRD codes as Current continuous renal replacement therapy - Liver disease as "End stage liver disease, defined as the presence of acute or chronic liver disease and recent history of one or more of the following: ascites, encephalopathy, variceal bleeding, bilirubin ≥ 2.0 mg/dL, albumin level ≤ 3.5 g/dL, prothrombin time ≥ 4 seconds prolonged, international normalised ratio (INR) ≥1.7 or prior liver transplant" - Organ transplant codes as A prior solid organ transplant or awaiting solid organ transplant - History of malignant neoplasm in previous 5 years 140.xx-208.xx (except 173.xx, non-melanoma skin cancer) - Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) - Personal history of non-familial medullary thyroid carcinoma - Drug abuse or dependence as Known use of non prescribed narcotics or illicit drugs - Encounter for contraceptive management, Oral contraceptives, and pregnancy as "Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)"
United States, Massachusetts
Brigham And Women's Hospital
Brigham and Women's Hospital
Principal Investigator: Jessie Franklin, PhD Jmfranklin@bwh.harvard.edu