Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05162183
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Glimepiride — DRUG
    Glimepiride dispensing claim is used as the reference group.
  • Liraglutide — DRUG
    Liraglutide dispensing claim is used as the exposure group.

Study Details

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.

Key Dates

Start date
Sep 1, 2019
Status verified
Jul 2023
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021

Study Design

Enrollment
3,474 participants (actual)

Arms

  • Arm: Glimepiride
    Reference Group
  • Arm: Liraglutide
    Exposure group

Primary Outcome Measure

Relative Hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up) [ Time Frame: 26-week follow-up window with a median follow-up time of 99 [84, 148] days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02135-

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Brigham and Women's Hospital· Boston, MA

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