Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174993
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2005-09-09
Brief Title:
Efficacy of Pioglitazone on Macrovascular Outcome in Patients With Type 2 Diabetes
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
PROspective PioglitAzone Clinical Trial In MacroVascular Events A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy
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:
PROactive
Brief Summary:
The purpose of this study is to determine whether pioglitazone once daily QD can delay the time to death heart attack acute coronary syndrome heart bypass surgery stroke leg bypass surgery or amputation in patients with type 2 diabetes
Detailed Description:
Diabetes mellitus is one of the most common non-communicable diseases worldwide More than 22 million persons have been diagnosed with diabetes in the European region of the International Diabetes Federation Complications of diabetes involving both microvascular and macrovascular systems contribute to increased disability and reduced life expectancy Damage to the coronary cerebral brain and peripheral vascular beds as a consequence of diabetes is responsible for the increased macrovascular illness and death associated with the disease
Insulin resistance is common to the genesis of both atherosclerosis and type 2 diabetes mellitus In diabetes insulin resistance is coupled to receptor dysfunction In atherosclerosis insulin resistance may have both direct effects on the cardiovascular system as well as indirect effects provoked by imbalances in blood glucose lipids clotting factors endothelial function and other factors Considerable indirect evidence suggests that peroxisome proliferator-activated receptor agonists may favorably influence macrovascular outcome either through modification of risk factors such as blood lipids or through effects on the vessel wall
Pioglitazone a thiazolidinedione compound discovered by Takeda Pharmaceutical Company Ltd functions as a peroxisome proliferator-activated receptor agonist as its mode of action
This study is designed to assess whether pioglitazone in combination with other medications administered for glycemic management of type 2 diabetes might reduce the incidence of macrovascular events associated with this disease compared with placebo Individuals who participate in this study will provide written informed consent and will be required to commit to screening and randomization visits and approximately 17 additional visits 1 every 2 months for the first year and every 3 months thereafter at the study center Study participation is anticipated to be about 40 months or approximately 3 years and 4 months Multiple procedures will occur at each visit which may include fasting blood collection physical examinations and electrocardiograms
Insulin resistance is common to the genesis of both atherosclerosis and type 2 diabetes mellitus In diabetes insulin resistance is coupled to receptor dysfunction In atherosclerosis insulin resistance may have both direct effects on the cardiovascular system as well as indirect effects provoked by imbalances in blood glucose lipids clotting factors endothelial function and other factors Considerable indirect evidence suggests that peroxisome proliferator-activated receptor agonists may favorably influence macrovascular outcome either through modification of risk factors such as blood lipids or through effects on the vessel wall
Pioglitazone a thiazolidinedione compound discovered by Takeda Pharmaceutical Company Ltd functions as a peroxisome proliferator-activated receptor agonist as its mode of action
This study is designed to assess whether pioglitazone in combination with other medications administered for glycemic management of type 2 diabetes might reduce the incidence of macrovascular events associated with this disease compared with placebo Individuals who participate in this study will provide written informed consent and will be required to commit to screening and randomization visits and approximately 17 additional visits 1 every 2 months for the first year and every 3 months thereafter at the study center Study participation is anticipated to be about 40 months or approximately 3 years and 4 months Multiple procedures will occur at each visit which may include fasting blood collection physical examinations and electrocardiograms
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 |
|---|---|---|---|
| U1111-1114-2854 | REGISTRY | WHO | None |