摘要
Background:We aimed to assess efficacy and safety,with a special focus on cardiovascular safety,of the novel dual GIP and GLP-1 receptor agonist tirzepatide versus insulin glargine in adults with type 2 diabetes and high cardiovascular risk inadequately controlled on oral glucose-lowering medications.Methods:This open-label,parallel-group,phase 3 study was done in 187 sites in 14 countries on five continents.Eligible participants,aged 18 years or older,had type 2 diabetes treated with any combination of metformin,sulfonylurea,or sodiumglucose co-transporter-2 inhibitor,a baseline glycated haemoglobin(HbA1c)of 7-5-10-5%(58-91 mmol/mol),body-mass index of 25 kg/m2 or greater,and established cardiovascular disease or a high risk of cardiovascular events.Participants were randomly assigned(1:1:1:3)via an interactive web-response system to subcutaneous injection of either once-per-week tirzepatide(5 mg,10 mg,or 15 mg)or glargine(100 U/mL),titrated to reach fasting blood glucose of less than 100 mg/dL.The primary endpoint was non-inferiority(0-3%non-inferiority boundary)of tirzepatide 10 mg or 15 mg,or both,versus glargine in HbA1c change from baseline to 52 weeks.All participants were treated for at least 52 weeks,with treatment continued for a maximum of 104 weeks or until study completion to collect and adjudicate major adverse cardiovascular events(MACE).Safety measures were assessed over the full study period.This study was registered with ClinicalTrials.gov,NCT03730662.
出处
《四川生理科学杂志》
2021年第8期1405-1405,共1页
Sichuan Journal of Physiological Sciences
