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

NCT06099067 | Completed

• 1 other identifier: D1843R00345
• Study Type: observational
• Target: 239,990
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 3-point MACE

  3-point MACE: Relative hazard of composite outcome of Stroke, MI, and Mortality

  Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days]

Study Arms (6)

CANVAS Canagliflozin

CANVAS expousre Group

Drug: Canagliflozin

CANVAS DPP4i

CANVAS reference Group

Drug: DPP4 inhibitor

LEADER Liraglutide

LEADER exposure Group

Drug: Liraglutide

LEADER DPP4i

LEADER reference Group

Drug: DPP4 inhibitor

SAVOR-TIMI Saxagliptin

SAVOR-TIMI exposure Group

Drug: Saxagliptin

SAVOR-TIMI 2nd generation Sulfonylurea

SAVOR-TIMI reference Group

Drug: 2nd generation Sulfonylurea

Interventions

Canagliflozin DRUG

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

CANVAS Canagliflozin

DPP4 inhibitor DRUG

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

CANVAS DPP4i; LEADER DPP4i

Liraglutide DRUG

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

LEADER Liraglutide

Saxagliptin DRUG

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

SAVOR-TIMI Saxagliptin

2nd generation Sulfonylurea DRUG

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

SAVOR-TIMI 2nd generation Sulfonylurea

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes mellitus (T2DM) adult patients enrolled in the two claims databases and are eligible to be included according to the inclusion and exclusion criteria of each of the three investigated clinical trial studies: CANVAS, LEADER and SAVOR-TIMI. All subjects meeting the inclusion and exclusion criteria will be assessed. Remaining sample size will be dependent on the number of matched subjects in each cohort using the two data sources combined.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Gothenburg, 43183, Sweden

Location

Related Links

• CANVAS
• LEADER
• SAVOR-TIMI
• The Redacted CSR synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin; Dipeptidyl-Peptidase IV Inhibitors; Liraglutide; saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: October 25, 2023
• Study Start: May 15, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from 05 December 2022
• Access Criteria: Protocol and SAP details along with programming code to be supplied upon request via mail.

Locations

SE (1)