Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT00521820
Status:
TERMINATED
Last Update Posted:
2012-02-28
First Post:
2007-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Congestive Heart Failure
Sponsor:
Takeda
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Higher incidence of hospitalization for congestive heart failure in pioglitazone-treated subjects compared to glyburide treated subjects.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1114-1029 | REGISTRY | WHO | View |