Phase II, Open-Label Study to Assess the Cardiovascular Side Effects and Efficacy for Reducing Blood Glucose Level in Type II Diabetes Mellitus Patients Being Treated With RAS 130 With or Without Diet and Exercise
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 460
- 试验地点
- 8
- 主要终点
- To determine cardiovascular side effects such as coronary artery disease (CAD) and congestive heart failure (CHF) in patients treated with RAS 130 along with diet and exercise.
研究概览
简要总结
Rationale: RAS 130 is an anti-diabetic agent used to lower the blood glucose level in Type II Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and exercise. RAS 130 works by restoring proper response to insulin in the body. RAS 130 acts primarily by increasing insulin sensitivity which improves glycemic index. It is presumed that RAS 130 does not cause cardiovascular side effects if it is given to Type II diabetes mellitus patients leading a healthy life style. Specifically, controlling diet is done according to American Diabetic Association & American Heart Association guidelines and also through doing aerobic exercises. Guideline for aerobic exercise is given in the design of the study.
Exercise is helpful in controlling body weight which can lower the risk for heart disease. Diabetes itself is one of the compounding factors for heart diseases. Exercise helps lowering the LDL cholesterol and raising the HDL cholesterol which is required to prevent heart diseases and achieve a better quality of life.
Purpose: The aim of this study is to prospectively assess and evaluate the cardiovascular side effects and reduction of blood glucose levels in the Type II Diabetes mellitus patients treated with RAS 130, who either met, or failed to meet criteria for diet and exercise.
详细描述
Objectives:
Primary Objective:
To determine the relatedness of cardio toxicity as a side effect in subjects with DM II who are treated with RAS 130 who either met, or failed to meet the criteria for diet and exercise.
Hypothesis I: There will be no evidence of cardiovascular side effects in subjects who are determined to have maintained proper diet and exercise "healthy lifestyle" throughout the study.
Hypothesis II: There may be evidence of cardiovascular side effects in subjects who are determined to neglect proper diet and exercise "unhealthy lifestyle" throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type II Diabetes Mellitus (non-insulin-dependent), not taking any anti-diabetic agent.
- •Fasting blood glucose level below 250mg/dL
- •Age 30 to 60 years
- •Both genders
- •HbA1c of 6.0% to 13.0%, inclusive
- •Body mass index (BMI) below 40 kg/m2
- •Female subjects not pregnant, not lactating, post-menopausal, surgically sterile or using effective contraceptive measures are included.
- •Provide signed Informed Consent
排除标准
- •Subject unable to give Informed Consent
- •Patients with Type I Diabetes Mellitus
- •a. History of ketoacidosis
- •Serum creatinine > 2.0 mg or above
- •Liver Function Test; Elevated liver enzymes: ALT/AST (2.5 times the upper limit of the reference range), Bilirubin Testing - Accept three fold, A/G ratio - Accept two fold
- •Hypercholesterolemia (more than 300mg)
- •Myocardial Infarction (MI) within 6 months
- •Severe or unstable angina
- •Elevated triglycerides >500 mg/dL
- •Abnormal EKG reading
- •Abnormal assessment in stress Echocardiography (ultrasound imaging)for Left Ventricular ejection fraction for congestive heart failure
- •Anemia (Hb <11 g/dl for men or <10 g/dl for women)
- •Blood Dyscrasia, Decrease in Hematocrit - Accept two fold, Low WBC count - Accept one fold, Decrease platelet count - Accept three fold
- •Macular edema/ macular degeneration
- •Patients who are taking insulin
- •Subjects with systolic blood pressure >170 mmHg or diastolic blood pressure >90 mmHg
- •Active participation in another trial
- •Subject physically unable to perform exercise due to neurologic or orthopedic conditions.
- •Patients taking antipsychotic medications.
- •Subjects testing positive for the illicit drugs (cocaine, amphetamines, heroin)
- •Subjects who smoke tobacco products
- •Females who are lactating, pregnant, or planning to become pregnant
- •Signs and symptoms of Congestive heart failure (such as shortness of breath or swelling in upper extremities)
- •History of severe edema or a medically serious fluid retention
结局指标
主要结局
To determine cardiovascular side effects such as coronary artery disease (CAD) and congestive heart failure (CHF) in patients treated with RAS 130 along with diet and exercise.
时间窗: 6 months
次要结局
- To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise(6 months)