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

Sponsor

American Scitech International (Other)

Overall Status

Unknown status

CT.gov ID

NCT00737152

Collaborator

Proactive Clinical Research (Other)

460

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes Mellitus	Other: RAS 130 with diet and exercise	Phase 2

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 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.

Secondary Objective:

To determine the effectiveness of RAS 130 on the reduction of blood glucose levels in subjects with DM II.

Hypothesis III: RAS 130 will be effective in reducing blood glucose levels as a single agent.

Hypothesis IV: RAS 130 will be effective in reducing blood glucose in combination with other anti- diabetic agents.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

460 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 All subjects will take RAS 130 administered orally in tablet form at a starting dose of 4 mg once a day or 2 mg tablets twice a day.	Other: RAS 130 with diet and exercise Entire population, which will also include existing patients, will be treated with RAS 130 along with diet and exercise. By the end of 6 months: 3 months of study and 3 months of follow-up, the entire population will be divided into two groups which will be determined through endpoints. The first group will be subjects with diet and exercise and the second group will be subjects without diet and exercise. The endpoints for the division of the groups are given in the design of the study. Other Names: diet and exercise

Arm

Intervention/Treatment

Experimental: 1

All subjects will take RAS 130 administered orally in tablet form at a starting dose of 4 mg once a day or 2 mg tablets twice a day.

Other: RAS 130 with diet and exercise

Entire population, which will also include existing patients, will be treated with RAS 130 along with diet and exercise. By the end of 6 months: 3 months of study and 3 months of follow-up, the entire population will be divided into two groups which will be determined through endpoints. The first group will be subjects with diet and exercise and the second group will be subjects without diet and exercise. The endpoints for the division of the groups are given in the design of the study.

Other Names:

diet and exercise

Outcome Measures

Primary Outcome Measures

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. [6 months]

Secondary Outcome Measures

To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

Subject unable to give Informed Consent
Patients with Type I Diabetes Mellitus

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Dr. JL Rohatagi Hospital	Sarvoday Nagar, Kanpur	UP	India