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

NCT ID: NCT00737152

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-04-30

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.

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.

Conditions

Type II Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RAS 130 with diet and exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

diet and exercise

Eligibility Criteria

Inclusion Criteria

1. Patients with Type II Diabetes Mellitus (non-insulin-dependent), not taking any anti-diabetic agent.

2. Fasting blood glucose level below 250mg/dL

3. Age 30 to 60 years

4. Both genders

5. HbA1c of 6.0% to 13.0%, inclusive

6. Body mass index (BMI) below 40 kg/m2

7. Female subjects not pregnant, not lactating, post-menopausal, surgically sterile or using effective contraceptive measures are included.

8. Provide signed Informed Consent

Exclusion Criteria

1. Subject unable to give Informed Consent

2. Patients with Type I Diabetes Mellitus

a. History of ketoacidosis

3. Serum creatinine > 2.0 mg or above

4. 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

5. Hypercholesterolemia (more than 300mg)

6. Myocardial Infarction (MI) within 6 months

7. Severe or unstable angina

8. Elevated triglycerides >500 mg/dL

9. Abnormal EKG reading

10. Abnormal assessment in stress Echocardiography (ultrasound imaging)for Left Ventricular ejection fraction for congestive heart failure

11. Anemia (Hb <11 g/dl for men or <10 g/dl for women)

12. Blood Dyscrasia, Decrease in Hematocrit - Accept two fold, Low WBC count - Accept one fold, Decrease platelet count - Accept three fold

13. Macular edema/ macular degeneration

14. Patients who are taking insulin

15. Subjects with systolic blood pressure >170 mmHg or diastolic blood pressure >90 mmHg

16. Active participation in another trial

17. Subject physically unable to perform exercise due to neurologic or orthopedic conditions.

18. Patients taking antipsychotic medications.

19. Subjects testing positive for the illicit drugs (cocaine, amphetamines, heroin)

20. Subjects who smoke tobacco products

21. Females who are lactating, pregnant, or planning to become pregnant

22. Signs and symptoms of Congestive heart failure (such as shortness of breath or swelling in upper extremities)

23. History of severe edema or a medically serious fluid retention

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Proactive Clinical Research

UNKNOWN

Sponsor Role: collaborator

American Scitech International

OTHER

Sponsor Role: lead

Responsible Party

American Scitech International

Principal Investigators

Ratna Grewal, MD

Role: STUDY_CHAIR

American Scitech International - eCRO

Prem Nandiwada, MD

Role: PRINCIPAL_INVESTIGATOR

Raritan Bay Medical Center

Locations

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

Countries

United States; India

Facility Contacts

Ratna Grewal, MD

Role: primary

rgreywal@americanscitech.com

908-941-5480

Ratna Grewal, MD

Role: primary

rgreywal@americanscitech.com

908-941-5480

Ratna Grewal, MD

Role: primary

rgreywal@americanscitech.com

908-941-5480

Ratna Grewal, MD

Role: primary

rgreywal@americanscitech.com

908-941-5480

Ratna Grewal, MD

Role: primary

rgreywal@americanscitech.com

908-941-5480

Other Identifiers

ASI-DMII 0808

Identifier Type: -

Identifier Source: org_study_id