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

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin; Drug: Liraglutide; Drug: Canagliflozin; Drug: DPP4 inhibitor; Drug: 2nd generation Sulfonylurea

Study type: Observational

Funder types: Industry

Identifiers

NCT06099067

D1843R00345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 239,990 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

239,990 participants in 6 patient groups

CANVAS Canagliflozin

Description:

CANVAS expousre Group

Treatment:

Drug: Canagliflozin

CANVAS DPP4i

Description:

CANVAS reference Group

Treatment:

Drug: DPP4 inhibitor

LEADER Liraglutide

Description:

LEADER exposure Group

Treatment:

Drug: Liraglutide

LEADER DPP4i

Description:

LEADER reference Group

Treatment:

Drug: DPP4 inhibitor

SAVOR-TIMI Saxagliptin

Description:

SAVOR-TIMI exposure Group

Treatment:

Drug: Saxagliptin

SAVOR-TIMI 2nd generation Sulfonylurea

Description:

SAVOR-TIMI reference Group

Treatment:

Drug: 2nd generation Sulfonylurea