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

Condition(s) targeted: Type II Diabetes Mellitus

Intervention: Rosiglitazone with diet and exercise (Other)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: American Scitech International

Official(s) and/or principal investigator(s):
Ratna Grewal, MD, Study Chair, Affiliation: American Scitech International - eCRO
Prem Nandiwada, MD, Principal Investigator, Affiliation: Raritan Bay Medical Center

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.

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

Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: To determine the effect of Rosiglitazone on reduction of blood glucose level with or without diet and exercise

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.

Minimum age: 30 Years. Maximum age: 60 Years. Gender(s): Both.

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

Sri Ramachandra University, Porur, Chennai, India

Raritan Bay Medical Center, Perth Amboy, New Jersey 08861, United States

MedCenter, East Brunswick, New Jersey 08816, United States

Robertwood Johnson Hospital, New Brunswick, New Jersey 08901, United States

Dr. JL Rohatagi Hospital, Sarvoday Nagar, Kanpur, UP, India

Web based electronic data capture research center; Contract Research Organization

Starting date: November 2009
Ending date: September 2014
Last updated: September 17, 2009