Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Diet
* Behavioral: Exercise
* Behavioral: Stop smoking
* Drug: Glucose lowering therapy
* Drug: Blood pressure lowering therapy
* Drug: Lipid lowering therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Microalbuminuria Exclusion Criteria: Stimulated serum C-peptide concentration less than 600 pmol/L Pancreatic insufficiency or diabetes secondary to pancreatitis Alcohol abuse Non-diabetic kidney disease Life-threatening disease with death probable within 4 years of study start

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment Arm<br>This arm will at any time during the active intervention period follow treatment guidelines by the Danish Medical Association for the treatment of type 2 diabetes. | Behavioral: Diet<br> <br> Behavioral: Exercise<br> <br> Behavioral: Stop smoking<br> <br> Drug: Glucose lowering therapy<br> <br> Drug: Blood pressure lowering therapy<br> <br> Drug: Lipid lowering therapy<br> <br> |
| Experimental: Intensive Treatment Arm<br>This arm will during the active intervention period be treated according to intensified multiple risk factor intervention following strict guidelines set out by the study protocol. | Behavioral: Diet<br> <br> Behavioral: Exercise<br> <br> Behavioral: Stop smoking<br> <br> Drug: Glucose lowering therapy<br> <br> Drug: Blood pressure lowering therapy<br> <br> Drug: Lipid lowering therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetic nephropathy |  | Four years | 
| Combined cardiovascular endpoint |  | Eight years | 
| Total mortality |  | 13 years | 
| Years of life years gained |  | 21 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 22 years | 
| Cardiovascular disease mortality |  | 22 years | 
| Stroke |  | 22 years | 
| Myocardial infarction |  | 22 years | 
| Coronary interventions |  | 22 years | 
| Amputations |  | 22 years | 
| Vascular surgery |  | 22 years | 
| Diabetic retinopathy |  | 22 years | 
| Diabetic nephropathy |  | 22 years | 
| Diabetic neuropathy |  | 22 years |