This trial is active, not recruiting.

Condition type 2 diabetes
Treatments diet, exercise, stop smoking, glucose lowering therapy, blood pressure lowering therapy, lipid lowering therapy
Sponsor Steno Diabetes Center
Start date January 1992
End date March 2007
Trial size 160 participants
Trial identifier NCT00320008, KA92071gm-KA99035g-KA99035gs


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Combined cardiovascular endpoint
time frame:

Secondary Outcomes

All cause mortality
time frame:
Cardiovascular disease mortality
time frame:
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Myocardial infarction
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Coronary interventions
time frame:
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Vascular surgery
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Diabetic retinopathy
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Diabetic nephropathy
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Diabetic neuropathy
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Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by Steno Diabetes Center.