Evaluate the Side Effects and Benefits of RAS 130 With or Without Diet and Exercise in Type II Diabetes Mellitus

Status unconfirmed · Phase 2

Conditions studied: Type II Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00737152

Run by

American Scitech International

People needed

460

Starts

2011-07-01

Expected to finish

2014-04-01

Last updated by the study team

2011-07-20

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MedCenter — East Brunswick, New Jersey, United States
• Robertwood Johnson Hospital — New Brunswick, New Jersey, United States
• Raritan Bay Medical Center — Perth Amboy, New Jersey, United States
• Sri Ramachandra University — Porur, Chennai, India
• Dr. JL Rohatagi Hospital — Sarvoday Nagar, Kanpur, Uttar Pradesh, India

Full record on ClinicalTrials.gov

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