A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (ACHIEVE-3) (J2A-MC-GZGU)

Eli Lilly Japan K.K.0 个研究点目标入组 1,576 人开始时间: 2023年11月24日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Have Type 2 Diabetes
•Have HbA1c >=7.0% (53 mmol/mol) to <=10.5% (91 mmol/mol), as determined by the central laboratory at screening.
•Have been on stable diabetes treatment with metformin >=1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization.
•Are of stable body weight (+-5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment

•Have Type 1 Diabetes
•Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
•Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
•Have a New York Heart Association functional classification IV congestive heart failure.
•Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
•Have a serum calcitonin level of >=35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
•Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.

Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 52 ]

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发起方