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

NCT00737152 | Unknown Phase 2

• 1 other identifier: ASI-DMII 0808
• Study Type: interventional
• Target: 460
• Locations: 2 countries
• Sites: 5

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.

Conditions

Type II Diabetes Mellitus

Keywords

RAS 130; Exercise; Diabetes Mellitus; Type II Diabetes; Diabetes; Aerobic

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

RAS 130 with diet and exercise OTHER

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.

Also known as: diet and exercise

1

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Scitech International: lead
• Proactive Clinical Research: collaborator

Study Sites (5)

MedCenter

East Brunswick, New Jersey, 08816, United States

Location

Robertwood Johnson Hospital

New Brunswick, New Jersey, 08901, United States

Location

Raritan Bay Medical Center

Perth Amboy, New Jersey, 08861, United States

Location

Sri Ramachandra University

Porur, Chennai, India

Location

Dr. JL Rohatagi Hospital

Sarvoday Nagar, Kanpur, Uttar Pradesh, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Diabetes Mellitus

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ratna Grewal, MD

  American Scitech International - eCRO

  STUDY CHAIR

• Prem Nandiwada, MD

  Raritan Bay Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: July 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

IN (2); US (3)