Evaluate the Side Effects and Benefits of RAS 130 With or Without Diet and Exercise in Type II Diabetes Mellitus (ASI-DMII)
Recruitment status was: Not yet recruiting
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.
Type II Diabetes Mellitus
Other: RAS 130 with diet and exercise
|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|
- 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 ]
- 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 ]
|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)|
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737152
|United States, New Jersey|
|East Brunswick, New Jersey, United States, 08816|
|Robertwood Johnson Hospital|
|New Brunswick, New Jersey, United States, 08901|
|Raritan Bay Medical Center|
|Perth Amboy, New Jersey, United States, 08861|
|Sri Ramachandra University|
|Porur, Chennai, India|
|Dr. JL Rohatagi Hospital|
|Sarvoday Nagar, Kanpur, UP, India|
|Study Chair:||Ratna Grewal, MD||American Scitech International - eCRO|
|Principal Investigator:||Prem Nandiwada, MD||Raritan Bay Medical Center|