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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter Gæde, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00320008
First received: April 27, 2006
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Type 2 Diabetes
Behavioral: Diet
Behavioral: Exercise
Behavioral: Stop smoking
Drug: Glucose lowering therapy
Drug: Blood pressure lowering therapy
Drug: Lipid lowering therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Diabetic nephropathy [ Time Frame: Four years ] [ Designated as safety issue: No ]
  • Combined cardiovascular endpoint [ Time Frame: Eight years ] [ Designated as safety issue: No ]
  • Total mortality [ Time Frame: 13 years ] [ Designated as safety issue: No ]
  • Years of life years gained [ Time Frame: 21 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Cardiovascular disease mortality [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Coronary interventions [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Amputations [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Vascular surgery [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Diabetic retinopathy [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Diabetic nephropathy [ Time Frame: 22 years ] [ Designated as safety issue: No ]
  • Diabetic neuropathy [ Time Frame: 22 years ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: January 1992
Estimated Study Completion Date: December 2025
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Treatment Arm
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 Behavioral: Exercise Behavioral: Stop smoking Drug: Glucose lowering therapy Drug: Blood pressure lowering therapy Drug: Lipid lowering therapy
Experimental: Intensive Treatment Arm
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 Behavioral: Exercise Behavioral: Stop smoking Drug: Glucose lowering therapy Drug: Blood pressure lowering therapy Drug: Lipid lowering therapy

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320008

Locations
Denmark
Slagelse Hospital
Slagelse, Denmark, 4200
Sponsors and Collaborators
Peter Gæde
Investigators
Study Director: Peter Gaede, Professor Slagelse Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Gæde, Associate Professor, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT00320008     History of Changes
Other Study ID Numbers: KA92071gm 
Study First Received: April 27, 2006
Last Updated: April 11, 2016
Health Authority: Denmark: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 27, 2016