Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145925
Status:
COMPLETED
Last Update Posted:
2008-09-17
First Post:
2005-09-02
Brief Title:
Blood Pressure and Glucose Lowering for the Prevention of Vascular Disease in High Risk Patients With Type 2 Diabetes
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
ADVANCE - Action in Diabetes and Vascular Disease Preterax and Diamicron - MR Controlled Evaluation
Status:
COMPLETED
Status Verified Date:
2008-09
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 provide information on the risks and benefits of routine blood pressure lowering regardless of blood pressure level and intensive lowering of blood glucose levels in patients with Type 2 diabetes at high risk of cardiovascular events The major outcomes of the study will be cardiovascular events heart attack stroke or dying as a result of cardiovascular disease as well as new or worsening diabetic eye and kidney disease
Detailed Description:
Patients with type 2 diabetes are at increased risks of macrovascular and microvascular disease both of which are reduced by control of raised blood pressure in hypertensive individuals Intensive glycaemic control has also been shown to reduce microvascular disease but the effects on macrovascular disease remain uncertain This study will examine the hypotheses that blood pressure lowering with an ACE inhibitor-diuretic combination and intensive glycaemic control with a sulphonylurea-based regimen in high-risk individuals with type 2 diabetes including hypertensive and non-hypertensive subjects reduces the incidence of both macrovascular and microvascular disease
The study is a 2 x 2 factorial randomised controlled trial that includes 11140 adults with type 2 diabetes at elevated risk of vascular disease Following 6 weeks on open label perindopril-indapamide combination eligible individuals were randomised to continued perindopril-indapamide or matching placebo and to an intensive gliclazide MR-based glucose control regimen aiming for HbA1c of 65 or lower or usual guidelines-based therapy Primary outcomes are first the composite of non-fatal stroke non-fatal myocardial infarction or cardiovascular death and second the composite of new or worsening nephropathy or diabetic eye disease These primary outcomes will be analysed jointly and separately The average duration of treatment and follow-up is 55 to 6 years The study is being conducted in 214 centres in Australasia Asia Europe and North America
ADVANCE is designed to provide reliable evidence about the balance of benefits and risks conferred by blood pressure lowering therapy and intensive glucose control therapy in high-risk diabetic patients irrespective of initial blood pressure or glucose levels
The study is a 2 x 2 factorial randomised controlled trial that includes 11140 adults with type 2 diabetes at elevated risk of vascular disease Following 6 weeks on open label perindopril-indapamide combination eligible individuals were randomised to continued perindopril-indapamide or matching placebo and to an intensive gliclazide MR-based glucose control regimen aiming for HbA1c of 65 or lower or usual guidelines-based therapy Primary outcomes are first the composite of non-fatal stroke non-fatal myocardial infarction or cardiovascular death and second the composite of new or worsening nephropathy or diabetic eye disease These primary outcomes will be analysed jointly and separately The average duration of treatment and follow-up is 55 to 6 years The study is being conducted in 214 centres in Australasia Asia Europe and North America
ADVANCE is designed to provide reliable evidence about the balance of benefits and risks conferred by blood pressure lowering therapy and intensive glucose control therapy in high-risk diabetic patients irrespective of initial blood pressure or glucose levels
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