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

July 19, 2011 updated by: American Scitech International

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

460

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Chennai
      • Porur, Chennai, India
        • Sri Ramachandra University
    • UP
      • Sarvoday Nagar, Kanpur, UP, India
        • Dr. JL Rohatagi Hospital
  • United States
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • MedCenter
      • New Brunswick, New Jersey, United States, 08901
        • Robertwood Johnson Hospital
      • Perth Amboy, New Jersey, United States, 08861
        • Raritan Bay Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Scitech International

Collaborators

Proactive Clinical Research

Investigators

  • Study Chair: Ratna Grewal, MD, American Scitech International - eCRO
  • Principal Investigator: Prem Nandiwada, MD, Raritan Bay Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASI-DMII 0808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type II Diabetes Mellitus

Clinical Trials on RAS 130 with diet and exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe