Status:
UNKNOWN
Evaluate the Side Effects and Benefits of RAS 130 With or Without Diet and Exercise in Type II Diabetes Mellitus
Lead Sponsor:
American Scitech International
Collaborating Sponsors:
Proactive Clinical Research
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
30-60 years
Phase:
PHASE2
Brief Summary
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 b...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00737152
Start Date
July 1 2011
End Date
April 1 2014
Last Update
July 20 2011
Active Locations (5)
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1
MedCenter
East Brunswick, New Jersey, United States, 08816
2
Robertwood Johnson Hospital
New Brunswick, New Jersey, United States, 08901
3
Raritan Bay Medical Center
Perth Amboy, New Jersey, United States, 08861
4
Sri Ramachandra University
Porur, Chennai, India