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Sponsors and Collaborators: |
American Scitech International GlaxoSmithKline |
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Information provided by: | American Scitech International |
ClinicalTrials.gov Identifier: | NCT00737152 |
Rationale: Rosiglitazone 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. Rosiglitazone works by restoring proper response to insulin in the body. Rosiglitazone acts primarily by increasing insulin sensitivity which improves glycemic index. It is presumed that Rosiglitazone 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 Rosiglitazone along with diet control and exercise.
Condition | Intervention | Phase |
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Type II Diabetes Mellitus |
Other: Rosiglitazone with diet and exercise |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Open Label, Non-Randomized Study to Evaluate the Cardiovascular Side Effects and Benefits of Reducing Blood Glucose Level in Patients Treated With Rosiglitazone Along With Diet and Exercise |
Estimated Enrollment: | 460 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | February 2014 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Rosiglitazone with diet and exercise
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Other: Rosiglitazone with diet and exercise
Entire population, which will also include existing patients, will be treated with Rosiglitazone 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.
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Objectives:
Primary:
- To determine cardiovascular side effects such as coronary artery disease (CAD) and congestive heart failure (CHF) in patients treated with Rosiglitazone along with diet and exercise.
The entire population of subjects taking Rosiglitazone will be divided on the basis of the results of endpoints of diet and exercise, which are as follows:
Secondary:
- To determine the effect of Rosiglitazone on reduction of blood glucose level with or without diet and exercise.
The entire population will be judged on the basis of reduction of blood glucose level which are as follows:
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Raritan Bay Medical Center | |
Perth Amboy, New Jersey, United States, 08861 | |
MedCenter | |
East Brunswick, New Jersey, United States, 08816 | |
Robertwood Johnson Hospital | |
New Brunswick, New Jersey, United States, 08901 | |
India, Chennai | |
Sri Ramachandra University | |
Porur, Chennai, India | |
India, UP | |
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 |
Responsible Party: | American Scitech International ( Dr. Ratna Grewal ) |
Study ID Numbers: | ASI-DMII 10810 |
Study First Received: | August 14, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00737152 |
Health Authority: | United States: Institutional Review Board |
Rosiglitazone Maleate Exercise Avandia Diabetes Mellitus |
Rosiglitazone Type II Diabetes Diabetes Aerobic |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Rosiglitazone |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |