Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

Type 2 Diabetes Clinical Trial

— Steno-2  

Official title:

Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00320008
• Other study ID #: KA92071gm
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1992
• Est. completion date: December 2025

Study information

• Verified date: April 2019
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2025
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Diet

• Exercise

• Stop smoking

Drug:
• Glucose lowering therapy

• Blood pressure lowering therapy

• Lipid lowering therapy

Locations

Country	Name	City	State
Denmark	Slagelse Hospital	Slagelse

Sponsors (1)

Lead Sponsor	Collaborator
Peter Gæde

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

Gæde J, Oellgaard J, Ibsen R, Gæde P, Nørtoft E, Parving HH, Kjellberg J, Pedersen O. A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study. Diabetologia. 2019 J — View Citation

Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008 Feb 7;358(6):580-91. doi: 10.1056/NEJMoa0706245. — View Citation

Gæde P, Oellgaard J, Carstensen B, Rossing P, Lund-Andersen H, Parving HH, Pedersen O. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. — View Citation

Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93. — View Citation

Gaede P, Vedel P, Parving HH, Pedersen O. Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. Lancet. 1999 Feb 20;353(9153):617-22. — View Citation

Kjaer LK, Oellgaard J, Henriksen T, Gaede P, Pedersen O, Poulsen HE. Indicator of RNA oxidation in urine for the prediction of mortality in patients with type 2 diabetes and microalbuminuria: A post-hoc analysis of the Steno-2 trial. Free Radic Biol Med. — View Citation

Oellgaard J, Gæde P, Persson F, Rossing P, Parving HH, Pedersen O. Application of urinary proteomics as possible risk predictor of renal and cardiovascular complications in patients with type 2-diabetes and microalbuminuria. J Diabetes Complications. 2018 — View Citation

Oellgaard J, Gæde P, Rossing P, Persson F, Parving HH, Pedersen O. Intensified multifactorial intervention in type 2 diabetics with microalbuminuria leads to long-term renal benefits. Kidney Int. 2017 Apr;91(4):982-988. doi: 10.1016/j.kint.2016.11.023. Ep — View Citation

Oellgaard J, Gæde P, Rossing P, Rørth R, Køber L, Parving HH, Pedersen O. Reduced risk of heart failure with intensified multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: 21 years of follow-up in the randomised Steno-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetic nephropathy		Four years
Primary	Combined cardiovascular endpoint		Eight years
Primary	Total mortality		13 years
Primary	Years of life years gained		21 years
Secondary	All cause mortality		22 years
Secondary	Cardiovascular disease mortality		22 years
Secondary	Stroke		22 years
Secondary	Myocardial infarction		22 years
Secondary	Coronary interventions		22 years
Secondary	Amputations		22 years
Secondary	Vascular surgery		22 years
Secondary	Diabetic retinopathy		22 years
Secondary	Diabetic nephropathy		22 years
Secondary	Diabetic neuropathy		22 years