Replication of the GRADE Diabetes Trial in Healthcare Claims Data

NCT ID: NCT05099198

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6403 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2021-08-01

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.

Conditions

Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Sitagliptin

Reference group

Sitagliptin

Intervention Type: DRUG

Sitagliptin dispensing claim is used as the reference

Glimepiride

Exposure group

Glimepiride

Intervention Type: DRUG

Glimepiride dispensing claim is used as the reference

Interventions

Sitagliptin

Sitagliptin dispensing claim is used as the reference

Intervention Type: DRUG

Glimepiride

Glimepiride dispensing claim is used as the reference

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age greater or equal than 30: days [0,0]
• Diagnosis of Type 2 Diabetes: days [- All Data, 0]
• 2+ recorded HbA1c levels: days [-365,0]
• Metformin use: days [-30, 0]

Exclusion Criteria

• Type 1 or Secondary DM: days [-All Data, 0]
• Previous organ transplant: days [-All Data, 0]
• HIV/AIDS: days [-All Data, 0]
• History of bariatric surgery: days [-All Data, 0]
• Congestive heart failure: days [-All Data, 0]
• NYHA >=3: days [-All Data, 0]
• Pancreatitis: days [-All Data, 0]
• Medullary thyroid cancer/MEN-2: days [-All Data, 0]
• History of MI: days [-365, 0]
• Stroke: days [-365, 0]
• Coronary Revascularization: days [-365, 0]
• PTCA/Stenting/CABG: days [-365, 0]
• Trans myocardial revascularization: days [-365, 0]
• Carotid bypass: days [-365, 0]
• Cerebrovascular revascularization: days [-365, 0]
• PVD: days [-365, 0]
• CCI >=10: days [-365, 0]
• History of cancer, other than non-melanoma skin cancer: days [-1,825, 0]
• Treatment of metformin more than 10 years: days [-3,650, 0]
• Treatment with any diabetes drug other than metformin; PCOS; symptomatic hyperglycemia; pregnancy; gestational diabetes: days [-180, 0]
• History of hemolytic anemia; history of severe liver disease; current alcoholism; chronic transfusion requirement; ESRD: days [-180, 0]
• Oral, IV, or IM cortisone, hydrocortisone, prednisone, methylprednisone, or dexamethasone: days [-90, 0]
• Treatment with atypical antipsychotics, language barriers, nursing home, or missing age or gender: days {-180, 0]
• Hospitalization with length of stay >3 days: days [-30, 0]

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shirley Vichy Wang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Wang, PhD, ScM

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018P002966-DUP-GRADE

Identifier Type: -

Identifier Source: org_study_id