Replication of the LEADER Diabetes Trial in Healthcare Claims
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168,690
- 试验地点
- 1
- 主要终点
- Relative hazard of composite outcome of Stroke, MI, and Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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
排除标准
- •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)"
研究组 & 干预措施
DPP-4 inhibitor
Reference group
干预措施: DPP-4 inhibitor (Drug)
Liraglutide
Exposure group
干预措施: Liraglutide (Drug)
结局指标
主要结局
Relative hazard of composite outcome of Stroke, MI, and Mortality
时间窗: Through study completion (a median of 154-188 days)
Relative hazard of composite outcome of MI, stroke, and mortality - Please refer to uploaded protocol for full definition due to size limitations.
次要结局
未报告次要终点
研究者
Shirley Vichy Wang
Associate Professor of Medicine
Brigham and Women's Hospital