Emulation of the SOUL Diabetes Trial in Healthcare Claims

NCT06659718 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-SOUL
• Study Type: observational
• Target: 43,650
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac event (MACE), including myocardial infarction, stroke and all cause death

  Hazard ratio

  Through study completion (1 day after cohort entry date until the first of outcome or censoring)

Other Outcomes (1)

• Cataract surgery (negative control)

  Through study completion (1 day after cohort entry date until the first of outcome or censoring)

Study Arms (2)

Oral semaglutide

Exposure group

Drug: Oral semaglutide

Sitagliptin

Reference group

Drug: Sitagliptin

Interventions

Oral semaglutide DRUG

New use of oral semaglutide dispensing claim is used as the exposure.

Oral semaglutide

Sitagliptin DRUG

New initiation of sitagliptin dispensing claim is used as the reference.

Sitagliptin

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population included patients aged 50 years or older with type 2 diabetes (T2DM) and established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).

You may qualify if:

• Type 2 diabetes mellitus
• Male or female, age equal to or above 50 years
• At least one of the following conditions:
• Coronary heart disease defined by at least one of the following criteria:
• i. Prior myocardial infarction ii. Prior coronary revascularization procedure ii. 50% or above stenosis in coronary artery documented by cardiac catheterization, computerized tomography coronary angiography iv. Coronary heart disease with ischemia documented by stress test with any imaging modality
• Cerebrovascular disease defined by at least one of the following criteria:
• i. Prior stroke ii. Prior carotid artery revascularization procedure iii. 50% or above stenosis in carotid artery documented by x-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound
• Symptomatic peripheral artery disease (PAD) defined by at least one of the following criteria:
• i. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at rest ii. Intermittent claudication with a 50% or above stenosis in peripheral artery (excluding carotid) documented by x-ray angiography, magnetic resonance angiography, computerized tomography angiography or Doppler ultrasound iii. Prior peripheral artery(excluding carotid) revascularization procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding trauma or osteomyelitis)
• Chronic kidney disease defined as: i. eGFR below 60mL/min/1.73 m\^2 (based on medical records using latest available and no more than 6 months old assessment)

You may not qualify if:

• Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within the past 60 days prior to the day of screening
• Heart failure presently classified as being in New York Heart Association Class IV
• Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before screening
• Semaglutide
• History of MEN-2 or family history of medullary thyroid cancer
• History of pancreatitis
• History of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass
• Plans for pregnancy during the course of the study for women of child-bearing potential
• History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior to randomization
• Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR \<30 ml/min/1.73 m2)
• Proliferative retinopathy or maculopathy requiring acute treatment
• History of diabetic ketoacidosis
• Missing age or gender
• Nursing home admission

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: October 24, 2024
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

US (1)