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

NCT06099067 · Completed

Last updated 2026-05-28

This clinical trial tests whether results from a real-world study match those of a randomized controlled trial in people with type 2 diabetes to evaluate heart-related outcomes.

Status Completed The study has finished.

Type Observational

Participants 239,990 people

Who can join all sexes

Timeline Started 2020-05 · est. completion 2023-08

Where 1 site · Sweden

What this study is testing ClinicalTrials.gov NCT06099067 ↗

Description as written by the study sponsor.

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.

Treatments tested

Canagliflozin Drug

Canagliflozin dispensing claim is used as the exposure drug in CANVAS replication
DPP4 inhibitor Drug

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

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

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

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

Main thing measured	3-point MACE
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06099067 ↗