GPGM-Type 2 Diabetes in Patients with Increased Cardiovascular Risk

Key Inclusion

•T2DM, 18 years or older.

•HbA1c 7.5 to 10.5%, inclusive; BMI ≥25 kg/m2; stable body weight (±5%) for prior 3 months.
•On stable treatment with unchanged dose of 1‐3 oral antihyperglycemic drugs (OAD), which may only
include metformin, SGLT2i, and/or sulfonylurea (SU) for at least 3 months prior to Visit 1.
•Coronary heart disease OR Peripheral arterial disease OR Cerebrovascular disease OR Chronic kidney
disease OR Congestive heart failure (see protocol for additional definitions & details).

Key Exclusion

• T1DM.
• History of insulin therapy, except for acute use (≤14 days), or the treatment of gestational diabetes.
• Use of any glucose lowering agent(s) other than stated in the inclusion criteria within 90 days before V1
(including GLP‐1RA and DPP‐4i).
• Have had the following within 2 months prior to Visit 1: acute MI, CVA (stroke), or hospitalization for CHF.
• Clinically significant gastric emptying abnormality,  gastric bypass or restrictive bariatric surgery, take drugs
that affect GI motility, or use of weight‐loss drugs within 3 months prior to V1.
• Liver disease (NAFLD is allowed), pancreatitis, active autoimmune abnormality, active or untreated
malignancy, proliferative retinopathy or maculopathy, heart or liver transplant or awaiting one.
• Previously participated in any other study investigating tirzepatide (LY3298176).

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