Safety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Congestive Heart Failure
- Registration Number
- NCT00521820
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this study is to compare the safety of Pioglitazone, once daily (QD), to Glyburide in Type 2 Diabetes Subjects with Mild to Moderate Congestive Heart Failure
- Detailed Description
Approximately 16 million people in the United States have been diagnosed with type 2 diabetes, a prevalence rate of approximately 6%, and the numbers are expected to increase with the increasing age of the general population. The risk factors associated with development of type 2 diabetes, such as age, obesity, and diet and exercise habits, also contribute to the development of cardiovascular disease. Additionally, patients with diabetes are at an increased risk for development of microvascular and macrovascular disease.
With regard to congestive heart failure, the risk of congestive heart failure is increased in subjects with diabetes in the absence of coronary artery disease; in subjects with diabetes and established coronary artery disease there is a higher overall risk and greater risk for more severe congestive heart failure. There is evidence that increasing insulin sensitivity and reducing hyperinsulinemia may reduce cardiovascular risks by reducing blood pressure, improving endothelial function, and through cardiac remodeling and function.
Pioglitazone is a thiazolidinedione for the treatment of type 2 diabetes, and is an agonist of the peroxisome proliferator-activated receptor. Pioglitazone received marketing approval in the United States in 1999. As part of the approval process, Takeda fulfilled a postmarketing study evaluating the effects of pioglitazone in the treatment of type 2 diabetes in subjects with congestive heart failure in a6-month clinical study.
An independent Data Safety Monitoring Board used to monitor the overall safety pattern of the study and to conduct unblinded reviews of data found a difference in the composite endpoint of time to first event that approached nominal statistical significance in favor of glyburide. As a result, the committee recommended that Takeda terminate the trial. Consistent with regulatory agency requirements, Takeda is submitting an abbreviated report that focuses on the safety data derived from the terminated study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 518
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pioglitazone QD Pioglitazone - Glyburide QD Glyburide -
- Primary Outcome Measures
Name Time Method Progression of Congestive Heart Failure. At First Event.
- Secondary Outcome Measures
Name Time Method Change from baseline in Glycosylated Hemoglobin. Weeks 12, 20 and Final Visit. Change from baseline in Fasting Plasma Glucose. At All Visits. Change from baseline in Triglycerides. Weeks 8, 16 and Final Visit. Change from baseline in cholesterol (total cholesterol, high-density lipoprotein and low-density lipoprotein). Weeks 8, 16 and Final Visit. Change from baseline in 6 Minute Walking test distance At Final Visit Physician & Subject Congestive Heart Failure Global Assessment Score At Final Visit Change in New York Heart Association classification At All Visits. Minnesota Living with Heart Failure Questionnaire total score. At Final Visit. Changes in blood pressure and heart rate. At All Visits. All cause mortality. At First Event.