A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

Launched by ELI LILLY AND COMPANY · Aug 7, 2019

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Eligibility criteria

• Inclusion Criteria:
• • Have type 2 diabetes mellitus (T2DM) for at least 1 year
• • Treated with diet and exercise and stable dose(s) of metformin 3 months prior to study entry with or without 1 additional oral antidiabetic medication (OAM) other than metformin.
• • Have a hemoglobin A1c (HbA1c) value at screening of ≥6.5% and ≤9.0 % if on metformin only.
• • Have a HbA1c value at screening of ≥6.0% and ≤8.5 %, if on metformin and 1 more allowed OAM.
• • Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m²) inclusive, at screening
• • Are of stable weight (±5%) \>3 months prior to screening
• Exclusion Criteria:
• • Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (\<6 months) ophthalmologic examination
• • Impaired renal estimated glomerular filtration rate (eGFR) \<60 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
• • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
• • Have had acute myocardial infarction, congestive heart failure New York Heart Association Class III or IV, history of or suspected ischemic heart disease, and/or cerebrovascular accident (stroke \[including transient ischemic attack\])