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

Primary Purpose

Type II Diabetes Mellitus

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RAS 130 with diet and exercise
Sponsored by
American Scitech International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring RAS 130, Exercise, Diabetes Mellitus, Type II Diabetes, Diabetes, Aerobic

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MedCenter
  • Robertwood Johnson Hospital
  • Raritan Bay Medical Center
  • Sri Ramachandra University
  • Dr. JL Rohatagi Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2008
Last Updated
July 19, 2011
Sponsor
American Scitech International
Collaborators
Proactive Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00737152
Brief Title
Evaluate the Side Effects and Benefits of RAS 130 With or Without Diet and Exercise in Type II Diabetes Mellitus
Acronym
ASI-DMII
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
American Scitech International
Collaborators
Proactive Clinical Research

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
RAS 130, Exercise, Diabetes Mellitus, Type II Diabetes, Diabetes, Aerobic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
RAS 130 with diet and exercise
Other Intervention Name(s)
diet and exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratna Grewal, MD
Organizational Affiliation
American Scitech International - eCRO
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Prem Nandiwada, MD
Organizational Affiliation
Raritan Bay Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedCenter
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ratna Grewal, MD
Phone
908-941-5480
Email
rgreywal@americanscitech.com
First Name & Middle Initial & Last Name & Degree
Sarath Babu, MD
First Name & Middle Initial & Last Name & Degree
Rajiv Patel, MD
Facility Name
Robertwood Johnson Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ratna Grewal, MD
Phone
908-941-5480
Email
rgreywal@americanscitech.com
First Name & Middle Initial & Last Name & Degree
Xiangbing Wang, MD
Facility Name
Raritan Bay Medical Center
City
Perth Amboy
State/Province
New Jersey
ZIP/Postal Code
08861
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ratna Grewal, MD
Phone
908-941-5480
Email
rgreywal@americanscitech.com
First Name & Middle Initial & Last Name & Degree
Prem Nandiwada, MD
Facility Name
Sri Ramachandra University
City
Porur
State/Province
Chennai
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ratna Grewal, MD
Phone
908-941-5480
Email
rgreywal@americanscitech.com
First Name & Middle Initial & Last Name & Degree
S P Thyagarajan, Ph.D
Facility Name
Dr. JL Rohatagi Hospital
City
Sarvoday Nagar, Kanpur
State/Province
UP
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ratna Grewal, MD
Phone
908-941-5480
Email
rgreywal@americanscitech.com
First Name & Middle Initial & Last Name & Degree
S N Agarwal, MD

12. IPD Sharing Statement

Links:
URL
http://www.americanscitech.com
Description
Web based electronic data capture research center; Contract Research Organization

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

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