Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225277
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2005-09-21
Brief Title:
Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Double-Blind Randomized Comparator-Controlled Study In Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl Versus Glimepiride on the Rate of Progression of Coronary Atherosclerotic Disease as Measured by Intravascular Ultrasound
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERISCOPE
Brief Summary:
The purpose of this study was to determine the efficacy of pioglitazone once daily QD compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound
Detailed Description:
Diabetes is a chronic disease with multiple metabolic defects that result in hyperglycemia arising from inadequate insulin activity Type 2 diabetes is usually the result of a progression from reduced sensitivity of hepatic and peripheral tissue cells to circulating insulin ie insulin resistance to a progressive inability of the body to produce adequate insulin to overcome insulin resistance ie insulin deficiency due to beta-cell insufficiency resulting in impaired glucose tolerance and ultimately overt diabetes In the United States an estimated 21 million people have diabetes with type 2 diabetes occurring in approximately 90 to 95 of cases The goal of treating type 2 diabetes is to control blood glucose and thereby prevent long-term complications Adequate glycemic control is paramount in attempting to avert chronic complications including blindness renal dysfunction resulting in dialysis or renal transplantation neuropathy non-traumatic amputations and macrovascular complications including myocardial ischemia and myocardial infarction stroke and peripheral arterial disease Intensive glucose management in the early stages of diabetes may help forestall such complications
Therapeutic agents have been developed to address each of the major functional metabolic defects associated with type 2 diabetes decreased beta-cell function elevated hepatic glucose output and insulin resistance Thiazolidinediones increase glucose utilization decrease gluconeogenesis and increase glucose disposal by binding to nuclear receptors known as peroxisome proliferator-activated receptors Thiazolidinediones reduce insulin resistance by enhancing insulin sensitivity in muscle cells adipose tissue and hepatic cells inhibiting hepatic gluconeogenesis with no direct impact on insulin secretion Thus thiazolidinediones improve glycemic control and result in reduced levels of circulating insulin without predisposing patients to hypoglycemia Peroxisome proliferator-activated receptors are found in tissues important for insulin action such as adipose tissue skeletal muscle and the liver The greatest concentration of peroxisome proliferator-activated receptors-gamma receptors is in adipose tissue
This study was designed to compare the effects of pioglitazone compared to glimepiride on progression of atherosclerotic disease as measured by intravascular ultrasound
Therapeutic agents have been developed to address each of the major functional metabolic defects associated with type 2 diabetes decreased beta-cell function elevated hepatic glucose output and insulin resistance Thiazolidinediones increase glucose utilization decrease gluconeogenesis and increase glucose disposal by binding to nuclear receptors known as peroxisome proliferator-activated receptors Thiazolidinediones reduce insulin resistance by enhancing insulin sensitivity in muscle cells adipose tissue and hepatic cells inhibiting hepatic gluconeogenesis with no direct impact on insulin secretion Thus thiazolidinediones improve glycemic control and result in reduced levels of circulating insulin without predisposing patients to hypoglycemia Peroxisome proliferator-activated receptors are found in tissues important for insulin action such as adipose tissue skeletal muscle and the liver The greatest concentration of peroxisome proliferator-activated receptors-gamma receptors is in adipose tissue
This study was designed to compare the effects of pioglitazone compared to glimepiride on progression of atherosclerotic disease as measured by intravascular ultrasound
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1114-0400 | REGISTRY | WHO | None |