Overview

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.

Principal investigator

Marcelo Correia
Internal Medicine

Eligibility criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
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For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Constance Shelsky
Not currently recruiting, contact if interested.