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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: DPP4 inhibitor; Drug: 2nd generation Sulfonylurea; Drug: Liraglutide; Drug: Canagliflozin; Drug: Saxagliptin

• Registration Number: NCT06099067
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2023-04-06
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239990

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CANVAS DPP4i	DPP4 inhibitor	CANVAS reference Group
LEADER DPP4i	DPP4 inhibitor	LEADER reference Group
SAVOR-TIMI 2nd generation Sulfonylurea	2nd generation Sulfonylurea	SAVOR-TIMI reference Group
LEADER Liraglutide	Liraglutide	LEADER exposure Group
CANVAS Canagliflozin	Canagliflozin	CANVAS expousre Group
SAVOR-TIMI Saxagliptin	Saxagliptin	SAVOR-TIMI exposure Group

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Gothenburg, Sweden