Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Double-Blind, Comparator-Controlled Study of Pioglitazone HCl vs Glyburide in the Treatment of Subjects With Type 2 (Non-Insulin Dependent) Diabetes Mellitus and Mild to Moderate Congestive Heart Failure
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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