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

Sponsor:	American Scitech International
Collaborator:	Proactive Clinical Research
Information provided by:	American Scitech International
ClinicalTrials.gov Identifier:	NCT00737152

Purpose

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	Intervention	Phase
Type II Diabetes Mellitus	Other: RAS 130 with diet and exercise	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by American Scitech International:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	460
Study Start Date:	July 2011
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: diet and exercise

Arms

Assigned Interventions

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 Name: 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.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737152

Locations

United States, New Jersey
MedCenter	Not yet recruiting
East Brunswick, New Jersey, United States, 08816
Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com
Sub-Investigator: Sarath Babu, MD
Sub-Investigator: Rajiv Patel, MD
Robertwood Johnson Hospital	Not yet recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com
Sub-Investigator: Xiangbing Wang, MD
Raritan Bay Medical Center	Not yet recruiting
Perth Amboy, New Jersey, United States, 08861
Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com
Principal Investigator: Prem Nandiwada, MD
India
Sri Ramachandra University	Not yet recruiting
Porur, Chennai, India
Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com
Sub-Investigator: S P Thyagarajan, Ph.D
Dr. JL Rohatagi Hospital	Not yet recruiting
Sarvoday Nagar, Kanpur, UP, India
Contact: Ratna Grewal, MD 908-941-5480 rgreywal@americanscitech.com
Sub-Investigator: S N Agarwal, MD

Sponsors and Collaborators

American Scitech International

Proactive Clinical Research

Investigators

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

More Information

Additional Information:

Web based electronic data capture research center; Contract Research Organization This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr. Ratna Grewal, American Scitech International
ClinicalTrials.gov Identifier:	NCT00737152 History of Changes
Other Study ID Numbers:	ASI-DMII 0808
Study First Received:	August 14, 2008
Last Updated:	July 19, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by American Scitech International:

RAS 130
Exercise
Diabetes Mellitus

Type II Diabetes
Diabetes
Aerobic

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012