Action in Diabetes and Vascular Disease Preterax and Diam... | NCT00949286

Studies
Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

NCT00949286

Sponsor

The George Institute

Status

Completed

Last Update Posted

May 19, 2014Estimated

Enrollment

8,494Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

Not provided

Countries

Australia
Canada
China
Czechia
Estonia
France
Germany
Hungary
India
Ireland
Italy
Lithuania
Malaysia
Netherlands
New Zealand
Philippines
Poland
Russia
Slovakia
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jul 28, 2009

First Submission Date that Met QC Criteria

Jul 28, 2009

First Posted Date

Jul 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2014

Last Update Posted Date

May 19, 2014Estimated

Name	Class
Servier	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

Detailed Description

The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,494Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)		2014
Death from any cause		2014

Secondary Outcomes

Measure	Description	Time Frame
Death from any cardiovascular cause		2014
Major clinical microvascular events - a composite of requirement for renal replacement therapy, death from renal disease and development of severe diabetes-related eye disease		2014

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participated in ADVANCE
Ability to provide informed consent

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All living participants who took part in the ADVANCE study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John P Chalmers	The George Institute	Principal Investigator
Stephen MacMahon	The George Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LCC 80 - Canberra Hospital		Garran	Australian Capital Territory		Australia
LCC 28 - Royal Prince Alfred Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17765963	Background	Patel A; ADVANCE Collaborative Group; MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S, Poulter N, Marre M, Cooper M, Glasziou P, Grobbee DE, Hamet P, Heller S, Liu LS, Mancia G, Mogensen CE, Pan CY, Rodgers A, Williams B. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007 Sep 8;370(9590):829-40. doi: 10.1016/S0140-6736(07)61303-8.
18539916

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases