Efficacy and safety of EGT0001442 compared with placebo in patients with type 2 diabetes mellitus inadequately controlled by diet and exercise and up to one oral anti-diabetes agent - none

Theracos Inc0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Male/female subjects >=18 years old
•2.Diagnosed with type 2 diabetes
•3.Body mass index(BMI)<= 45 Kg/m2
•4.HbA1c between 7 and 10%(Inclusive) as screening
•5.FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies
•6.Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent.
•7.If taking anti-diabetic medication, dose and regimen must be stable for past 3 months
•8.If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months
•9.If taking lipid modifying therapy, dose and regimen must be stable for past 3 months
•10.Blood glucose level <250 mg/dL based on finger stick blood glucose for all subjects at randomization

•1.Hemoglobinopathy that affects HbA1c measurement
•2.Current use of injected therapy for treatment of diabetes(insulin or GLP-1 receptor based therapy)
•3.Genitourinary tract infection within 6 weeks of screening
•4.Greater than 2 episodes of genitourinary tract infection in the past year
•5.History of kidney stones, bladder malfunctioning or other significant risk factor for urinary tract infections
•6.eGFR, as calculated by the modification of diet in renal disease study equation(MDRD), <50 mL/min/1.73 m2
•7.Abnormal tests of liver function ALT, AST or bilirubin >= 3x ULN
•8.Diagnosis of retinopathy or significant nephropathy (eGFR <50 mL/min/1.73 m2)
•9.Uncontrolled hypertension (systolic BP >160 or diastolic BP >95)
•10.Not willing to use effective birth control, if female with child bearing potential
•11.Life expectancy < 2 years
•12.New York Heart Association(NYHA) class 4 heart failure
•13.Sera positive of HCV, HIV, or positive on drug screen
•14.Currently participating in another interventional trial
•15.Previous treatment with EGT0001442 or EGT0001474
•16.Not able to comply with the study scheduled visits

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