Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116545
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2005-06-29
Brief Title:
TART - Troglitazone Atherosclerosis Regression Trial
Sponsor:
Parke-Davis
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
TART - Troglitazone Atherosclerosis Regression Trial
Status:
COMPLETED
Status Verified Date:
2005-06
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:
None
Brief Summary:
The purpose of this study is to determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients
Detailed Description:
Insulin resistance and hyperinsulinism appear to be important risk factors for the development of atherosclerosis in diabetes patients The atherogenic potential of insulin has been shown to improve cholesterol and may have an effect on the thickness and structure of the arterial wall Troglitazone is an oral diabetic agent that treats insulin resistance Based on the initial data available it would appear that troglitazone may be effective in both glycemic control and improved atherosclerosis risk in diabetes patients This study will compare the effects of troglitazone to placebo in insulin-requiring diabetes patients on both glycemic control and progression of atherosclerosis
A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were recruited and entered an 8 week run-in phase to stabilize diet exercise insulin dose and glucose levels Upon successful completion of the run-in phase all patients were randomized into one of two groups to receive either troglitazone 400mgday or a matching placebo while continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose levels between 100 to 150 mgdL
Follow up visits occurred every 2 weeks for 2 months every 4 weeks for 2 months then every 8 weeks for the remainder of the 2-year trial The progression of atherosclerosis was measured by ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment
A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were recruited and entered an 8 week run-in phase to stabilize diet exercise insulin dose and glucose levels Upon successful completion of the run-in phase all patients were randomized into one of two groups to receive either troglitazone 400mgday or a matching placebo while continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose levels between 100 to 150 mgdL
Follow up visits occurred every 2 weeks for 2 months every 4 weeks for 2 months then every 8 weeks for the remainder of the 2-year trial The progression of atherosclerosis was measured by ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment
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 |
|---|---|---|---|
| 991-081-00 | None | None | None |