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
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- Theracos Inc
- 入组人数
- 300
- 试验地点
- 11
- 主要终点
- The primary objective of this trial study is to assess the efficacy of EGT0001442 on lowering HbA1c
研究概览
简要总结
Thisstudy is a multinational, 2 arm parallel group, randomized, double-blindplacebo-controlled study to compare treatment with once daily EGT0001442, 20 mgcapsules to matching placebo in either treatment-naïve type 2 diabetic patients(i.e. those not taking an anti-hyperglycemic agent for ≥16 weeks prior to studyentry) or patients treated with one oralanti-diabetes drug. The study is already being conducted in 12 sites in US and7 sites in Mexico and will be conducted in Eleven centers in India. The primaryoutcome measure is to assess the efficacy of EGT0001442 in lowering HbA1c atweek 24 compared with Placebo.
ThePrimary Outcome Measure is:
To assessefficacy of EGT0001442 in lowering HbA1c at week 24 compared with placebo.
The Secondary Outcome measures are:
Toassess the efficacy of EGT0001442 in lowering FPG at weeks 2 and 24 comparedwith placebo. To assess the efficacy of EGT0001442 based on the proportion ofsubjects who reach the American Diabetes Association (ADA) target HbA1c of<7% in the EGT0001442 group compared with placebo.To assess the effect ofEGT0001442 on systolic and diastolic blood pressure compared with placebo. Toassess the effect of EGT0001442 on body weight compared with placebo. To assessthe change in HbA1c change over time, week 1 to week 96.To assess the safety ofEGT0001442 in patients with T2DM
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The primary objective of this trial study is to assess the efficacy of EGT0001442 on lowering HbA1c
时间窗: at week 24 compared with Placebo.
次要结局
- To assess the efficacy of EGT0001442 in lowering FPG(at weeks 2 and 24 compared with placebo)
- To assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association(ADA) target HbA1c of 7% in the EGT0001442 group compared with placebo(from week 1 to week 96)
- To assess the effect of EGT0001442 on systolic and diastolic BP(at screening, run in period, and from week 1 to week 96)
- To assess the effect of EGT0001442 on body weight compared with placebo(at screening, run in period, week 1, 6, 8,10,12,14 and 15.)
- To assess the change from baseline in HbA1c over time(from week 1 to week 96)
- To assess the safety of EGT0001442 in patients with T2DM(from week 1 to week 96)