A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes - I8F-MC-GPIH

Eli Lilly Cork Limited0 个研究点目标入组 250 人开始时间: 2022年10月11日最近更新: 2024年8月21日

适应症

试验速览

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•Have type 2 diabetes, Have HbA1c =7.0% (=53 mmol/mol) to =9.5% (=80 mmol/mol), Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening, No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, SGLT-2i, and/or sulfonylurea, for at least 3 months before screening, Have stable body weight (±5%) during the 90 days preceding screening, Have BMI =25 kilogram/square meter (kg/m²)

•Have type 1 diabetes, Have been treated with insulin prior to screening. Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery., Have a history of chronic or acute pancreatitis, Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or Nonproliferative diabetic retinopathy requiring acute treatment, Have NYHA Functional Classification Class IV CHF, Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)., Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over-the-counter, or alternative remedies, Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation, Have any of these cardiovascular conditions within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization due to congestive heart failure (CHF)

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