Replication of the GRADE Diabetes Trial in Healthcare Claims Data

NCT05099198 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-GRADE
• Study Type: observational
• Target: 6,403
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Time until failure to maintain metabolic control

  Lab based algorithm: time until failure to maintain metabolic control (HbA1c level \>= 7.0% or 53 mmol/mol)

  Through censoring or study completion, up to 765 days after cohort entry

Secondary Outcomes (2)

• Time until a severe hypoglycemic episode

  Through censoring or study completion, up to 765 day after cohort entry

• HbA1C change from baseline

  Through censoring or study completion, up to 765 days after cohort entry

Study Arms (2)

Sitagliptin

Reference group

Drug: Sitagliptin

Glimepiride

Exposure group

Drug: Glimepiride

Interventions

Sitagliptin DRUG

Sitagliptin dispensing claim is used as the reference

Sitagliptin

Glimepiride DRUG

Glimepiride dispensing claim is used as the reference

Glimepiride

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes who have previously been treated with metformin.

You may qualify if:

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

You may not qualify if:

• 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 \[-365, 0\]

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitagliptin Phosphate; glimepiride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: October 29, 2021
• Study Start: September 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)