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
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 10
- 主要终点
- Change From Baseline in Hemoglobin A1c at 24 Weeks
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures, body weight and compare with the respective placebo groups.This study also assess the change from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).
详细描述
EGT0001442 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001442 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. Hence the blood glucose levels are significantly decreased and the efficacy of EGT001442 can be established by assessing the three months average blood glucose levels (HbA1c). Due to the increased urinary output, the effect of EGT001442 on blood pressure levels are also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ≥18 years old
- •Diagnosed with type 2 diabetes
- •Body mass index (BMI) ≤ 45 kg/m2
- •HbA1c between 7 and 10% (inclusive) at screening
- •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
- •Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent
- •If taking anti-diabetic medication, dose and regimen must be stable for past 3 months
- •If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months
- •If taking lipid modifying therapy, dose and regimen must be stable for past 3 months
- •Blood glucose <250 mg/dL based on finger stick blood glucose for all subjects at randomization
排除标准
- •Hemoglobinopathy that affects HbA1c measurement
- •Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor based therapy)
- •Genitourinary tract infection within 6 weeks of screening
- •Greater than 2 episodes of genitourinary tract infection in the past year
- •History of kidney stones, bladder malfunction or other significant risk factor for urinary tract infections
- •eGFR, as calculated by the modification of diet in renal disease study equation (MDRD), < 50 mL/min/1.73 m2
- •Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULN
- •Diagnosis of retinopathy or significant nephropathy (eGFR < 50 mL/min/1.73 m2
- •Uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >95)
- •Not willing to use effective birth control, if female with child-bearing potential
- •Life expectancy < 2 years
- •New York Heart Association (NYHA) Class 4 heart failure
- •Sera positive of HCV, HIV, or positive on drug screen
- •Currently participating in another interventional trial
- •Previous treatment with EGT0001442 or EGT0001474
- •Not able to comply with the study scheduled visits
研究组 & 干预措施
EGT0001442
EGT0001442 capsule, 20 mg, daily, 96 weeks
干预措施: EGT0001442 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c at 24 Weeks
时间窗: Baseline and Week 24
Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment
次要结局
- Changes in Systolic and Diastolic Blood Pressure at Week 24(Baseline and Week 24)
- Change From Baseline Over Time in Fasting Plasma Glucose (FPG)(24 weeks)
- Changes in Body Weight at Week 24(Baseline and week 24)
- Percentage of Subjects Achieving HbA1c <7%(Baseline and up to 96 weeks)
- Change From Baseline in HbA1c Over 96 Weeks Time(Baseline and up to 96 weeks)