Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)

Harmonizing RCT-Duplicate Emulations: A Real World Replication Program Analyzing Three Clinical Trials, CANVAS, LEADER, and SAVOR TIMI in Type 2 Diabetes Mellitus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06099067

Acronym

HARRP

Enrollment

239990

Registered

2023-10-25

Start date

2020-05-15

Completion date

2023-08-31

Last updated

2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Clinical Trial, Emulation, Epidemiology, Type 2 Diabetes, Regulatory, Real World Evidence, Real World Data

Brief summary

Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses.

Detailed description

RCT-duplicate (RCT-D) is an initiative led by the Brigham and Women's Hospital and Harvard Medical School, that selected 30 clinical trials as part of an empirical experiment where these trials would be emulated using RWD. AstraZeneca will replicate three emulations CANVAS, LEADER, and SAVOR TIMI from among the 30 plus clinical trials analyzed in RCT-D. These clinical trials assess type 2 diabetes mellitus drugs. The replications will be conducted on the Instant Health Data PANALGOS (IHD) platform to assess these studies in two claims databases Optum and IBM Watson Market Scan. The aim is to recreate these three emulations to investigate the reproducibility of the emulations, increase transparency and better understand the process of trial emulations; and where possible, contribute with potential improvements to the RCT-D framework.

Interventions

DRUGCanagliflozin

Canagliflozin dispensing claim is used as the exposure drug in CANVAS replication

DRUGDPP4 inhibitor

DPP4 inhibitor dispensing claim is used as the reference drug in CANVAS and LEADER replications

DRUGLiraglutide

Liraglutide dispensing claim is used as the Exposure drug in LEADER replication

DRUGSaxagliptin

Saxagliptin dispensing claim is used as the Exposure drug in SAVOR-TIMI replication

DRUG2nd generation Sulfonylurea

2nd generation Sulfonylurea dispensing claim is used as the Exposure drug in SAVOR-TIMI replication

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

The Eligibility Criteria for CANVAS, LEADER and SAVOR-TIMI are replicated Please see the Criteria for each under: * CANVAS: https://clinicaltrials.gov/ct2/show/NCT03936010 * LEADER: https://clinicaltrials.gov/ct2/show/NCT03936049 * SAVOR-TIMI: https://clinicaltrials.gov/ct2/show/NCT03936023

Design outcomes

Primary

Measure	Time frame	Description
3-point MACE	Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days]	3-point MACE: Relative hazard of composite outcome of Stroke, MI, and Mortality

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026