Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

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

Eligibility

You can join if…

Open to people ages 40 years and up

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
  • Are currently planning treatment for diabetic retinopathy and/or macular edema
  • 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 currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
  • 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)
  • Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement

Locations

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)
    La Jolla California 92037 United States
  • Diabetes and Endocrine Associates
    La Mesa California 91942 United States
  • AMCR Institute
    Escondido California 92025 United States

Details

Status
in progress, not 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 research study
Study Type
Interventional
Participants
About 13299 people participating
Last Updated