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Completed

NCT Number: NCT06099067

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Gothenburg, 43183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 3-point MACE

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: HARRP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2023
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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