Evaluate the Side Effects and Benefits of RAS 130 With or Without Diet and Exercise in Type II Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | July 2011 |
| End Date: | April 2014 |
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.
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.
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.
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.
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
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