Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2) - I8F-MC-GPH

Masaki Takeshi0 个研究点目标入组 64 人开始时间: 2021年3月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Have Type 2 Diabetes (T2DM) with HbA1c >=7% to =<10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
•-Have a BMI of >=27 kg/square meter
•-Are overweight or have obesity
•-Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
•-Are at least 18 years of age and age of majority per local laws and regulations

•-Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
•-Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
•-Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
•-Have self-reported change in body weight >5kg within 3 months prior to screening
•-Have had a history of chronic or acute pancreatitis
•-Change in body weight greater than 5 kg within 3 months prior to starting study
•-Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
•-Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
•-History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
•-Any lifetime history of a suicide attempt

发起方

Masaki Takeshi