Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion
Principal Investigator
Jeremy Pettus (ucsd)William J French (ucla)
Photo of Jeremy Pettus
Jeremy Pettus

Description

Summary

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Official Title

The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)

Keywords

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hypoglycemic Agents Physiological Effects of Drugs Tirzepatide Incretins Glucagon-Like Peptide 1 Gastric Inhibitory Polypeptide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dulaglutide LY3298176

Eligibility

You can join if…

Open to people ages 40 years and up

  • Have a diagnosis of type 2 diabetes
  • Have confirmed atherosclerotic cardiovascular disease
  • HbA1c ≥7.0% to ≤10.5%
  • Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

You CAN'T join if...

  • Have had a major cardiovascular event within the last 60 days
  • Have type 1 diabetes mellitus
  • Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
  • Have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
  • Currently planning a coronary, carotid, or peripheral artery revascularization
  • Have a history of pancreatitis
  • Have a history of ketoacidosis or hyperosmolar state/coma
  • Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Locations

  • UCSD Clinical & Translational Research Institute not yet accepting patients
    La Jolla California 92037 United States
  • Harbor UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Valley Endocrine, Fresno accepting new patients
    Fresno California 93720 United States
  • Diabetes Associates Medical Group accepting new patients
    Orange California 92868 United States

Lead Scientists at UC Health

  • Jeremy Pettus (ucsd)
    Authored (or co-authored) 38 research publications.
  • William J French (ucla)
    Adjunct Professor, Medicine. Authored (or co-authored) 26 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
ID
NCT04255433
Phase
Phase 3
Study Type
Interventional
Last Updated