Evaluate the Side Effects and Benefits of Rosiglitazone With or Without Diet and Exercise in Type II Diabetes Mellitus - Full Text View

Sponsor:	American Scitech International
Collaborators:	Proactive Clinical Research GlaxoSmithKline
Information provided by:	American Scitech International
ClinicalTrials.gov Identifier:	NCT00737152

Purpose

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
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 Type II Diabetes Mellitus Patients Treated With Rosiglitazone Along With Diet and Exercise

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness Heart Diseases

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by American Scitech International:

Primary Outcome Measures:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the effect of Rosiglitazone on reduction of blood glucose level with or without diet and exercise [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	460
Study Start Date:	February 2010
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rosiglitazone with diet and exercise	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.

Arms

Assigned Interventions

1: Experimental

Rosiglitazone with diet and exercise

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.

Detailed Description:

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:

Subject should not gain more than 5 pounds or maintains the initial weight provided the LDL remains at baseline
BMI lowers by 5 points may be same as baseline or should not go more than 2 points provided LDL remains at baseline
HDL increases by 10 points (example the baseline value of HDL is 35mg/dL should increase to 45mg/dL)
LDL lowers by 15 points (example the baseline value of LDL is 130mg/dL should decrease to 115mg/dL)
Even if the blood glucose level is above the fasting level (80-120mg/dL) but the HbA1c is within the normal range(6.5%) the subject will continue in the study.

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:

Controlled blood glucose level (example fasting 120mg/dL and HbA1c less than 6.5%)
Uncontrolled blood glucose level (example fasting more than 120mg/dL and HbA1c more than 6.5%)
The blood glucose level will be tested every month and if it is under control then the subject will continue the study.
If the blood glucose level is not under control then the subject will be given combination treatment with Metformin.
If blood glucose level is not under control after 1 month with the combination treatment of Rosiglitazone and Metformin then the subject will be given another combination treatment along with Rosiglitazone.
If the subject demonstrates control of blood glucose level with or without diet and exercise along with the treatment of Rosiglitazone or combination of Rosiglitazone and Metformin or combination of Rosiglitazone and another anti-diabetic agent then the subject will continue the study.
The cardiovascular side effects will be determined in both groups; group one with reduction in blood glucose with diet and exercise and the other group with reduction in blood glucose without diet and exercise.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Existing patients taking Rosiglitazone at least 6 months.
Fasting blood glucose level below 200mg/dL taking Rosiglitazone
Fasting blood glucose level below 250mg/dL not taking any drug
Age 30 to 60 years
Both genders
HbA1c of 6.0% to 13.0%, inclusive.
Body mass index (BMI) below 40 kg/m^2.
Patients with Type II Diabetes mellitus (non-insulin-dependent).
Subject physically unable to perform exercise due to neurologic or orthopedic conditions.
Female subjects not pregnant, pre and post-menopausal, surgically sterile or using effective contraceptive measures are included.
Provide signed Informed Consent.

Exclusion Criteria:

Patients with Diabetes mellitus Type I
Inability to give consent
Elevated liver enzymes: ALT/AST (2.5 times the upper limit of the reference range)
Serum creatinine > 2.0 mg or above
Hypercholesterolemia (more than 300mg)
History of ketoacidosis
S/S of Congestive heart failure (such as shortness of breath or swelling)
Myocardial Infarction (MI) within 6 months
Severe or unstable angina
Systolic blood pressure >170 mmHg or diastolic blood pressure >90 mmHg
Anemia (Hb <11 g/dl for men or <10 g/dl for women)
Patients who are taking nitrates or insulin
Participation in another trial
History of severe edema or a medically serious fluid retention
Female who are lactating, pregnant, or planning to become pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737152

Locations

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

Sponsors and Collaborators

American Scitech International

Proactive Clinical Research

GlaxoSmithKline

Investigators

Study Chair:	Ratna Grewal, MD	American Scitech International - eCRO
Principal Investigator:	Prem Nandiwada, MD	Raritan Bay Medical Center

More Information

Additional Information:

Web based electronic data capture research center; Contract Research Organization This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	American Scitech International ( Dr. Ratna Grewal )
Study ID Numbers:	ASI-DMII 0808
Study First Received:	August 14, 2008
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00737152 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by American Scitech International:

Rosiglitazone Maleate
Exercise
Avandia
Diabetes Mellitus

Rosiglitazone
Type II Diabetes
Diabetes
Aerobic

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010