Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria (Steno-2)

• Diabetic nephropathy [ Time Frame: Four years ]
  
• Combined cardiovascular endpoint [ Time Frame: Eight years ]
  
• Total mortality [ Time Frame: 13 years ]
  
• Years of life years gained [ Time Frame: 21 years ]
  

• All cause mortality [ Time Frame: 22 years ]
  
• Cardiovascular disease mortality [ Time Frame: 22 years ]
  
• Stroke [ Time Frame: 22 years ]
  
• Myocardial infarction [ Time Frame: 22 years ]
  
• Coronary interventions [ Time Frame: 22 years ]
  
• Amputations [ Time Frame: 22 years ]
  
• Vascular surgery [ Time Frame: 22 years ]
  
• Diabetic retinopathy [ Time Frame: 22 years ]
  
• Diabetic nephropathy [ Time Frame: 22 years ]
  
• Diabetic neuropathy [ Time Frame: 22 years ]
  

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.