A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

Launched by ELI LILLY AND COMPANY · May 14, 2019

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Eligibility criteria

• Inclusion Criteria:
• • Have T2DM for at least 6 months
• • Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry
• • Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin
• • Have a body mass index (BMI) between 25 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 (\<1.5 years) ophthalmologic examination
• • Impaired renal estimated glomerular filtration rate (eGFR) \<45 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 or current cardiovascular, respiratory, hepatic, renal, 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