Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320008
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2019-04-04
First Post:
2006-04-27
Brief Title:
Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria
Sponsor:
Peter Gæde
Organization:
Steno Diabetes Center Copenhagen
Study Overview
Official Title:
Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2019-04
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:
Steno-2
Brief Summary:
The purpose of this study is to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria
Detailed Description:
The overall description of the Steno-2 Study is stated in four protocols approved by the regulatory authorities in Denmark The protocol identification numbers are KA 92071gm 4 years intervention KA-99035g 8 years intervention KA-99035-GS 13 years follow-up since intervention start and H-KA-99035-GS 21 year follow-up since intervention start
The aim of the study was to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria The primary end point after four years of intervention was to progression to diabetic nephropathy with other microvascular complications as secondary end points The primary end point after eight years of intervention was a composite CVD endpoint with microvascular complications as secondary end points
The interventional part of the study was ended in December 2001 after a total of eight years of intervention From that time on all patients were followed in a post-trial study Also during post-trial period all patients in both original treatment arms received similar treatment resembling the treatment given in the original intensive arm of the study The aim of the post-trial follow-up was to investigate the effect of intensified multifactorial intervention on i mortality and ii years of life gained respectively with such an interventional approach
Endpoints in the two parts of the post-trial follow-up
Part one at 13 years since start of intervention
Primary endpoint Total mortality Secondary endpoints Cardiovascular endpoints as defined previously Microvascular disease
Part two at 21 years since start of intervention
Primary endpoint Difference in median time to 50 mortality in each of the two original treatment groups Secondary endpoints Cardiovascular endpoints as defined previously Recurrent cardiovascular events Microvascular disease
The aim of the study was to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria The primary end point after four years of intervention was to progression to diabetic nephropathy with other microvascular complications as secondary end points The primary end point after eight years of intervention was a composite CVD endpoint with microvascular complications as secondary end points
The interventional part of the study was ended in December 2001 after a total of eight years of intervention From that time on all patients were followed in a post-trial study Also during post-trial period all patients in both original treatment arms received similar treatment resembling the treatment given in the original intensive arm of the study The aim of the post-trial follow-up was to investigate the effect of intensified multifactorial intervention on i mortality and ii years of life gained respectively with such an interventional approach
Endpoints in the two parts of the post-trial follow-up
Part one at 13 years since start of intervention
Primary endpoint Total mortality Secondary endpoints Cardiovascular endpoints as defined previously Microvascular disease
Part two at 21 years since start of intervention
Primary endpoint Difference in median time to 50 mortality in each of the two original treatment groups Secondary endpoints Cardiovascular endpoints as defined previously Recurrent cardiovascular events Microvascular disease
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