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A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT)

Phase 1
Conditions
Type 2 Diabetes Mellitus
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
CTIS2023-507846-96-00
Lead Sponsor
Eli Lilly & Co.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
13299
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 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 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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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