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