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

Peter Gæde

Status: Active, not recruiting

Conditions: Type 2 Diabetes

Treatments: Behavioral: Diet; Drug: Lipid lowering therapy; Drug: Blood pressure lowering therapy; Behavioral: Exercise; Behavioral: Stop smoking; Drug: Glucose lowering therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00320008

KA92071gm

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

Standard Treatment Arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Diet

Drug: Lipid lowering therapy

Drug: Blood pressure lowering therapy

Behavioral: Stop smoking

Drug: Glucose lowering therapy

Behavioral: Exercise

Intensive Treatment Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Diet

Drug: Lipid lowering therapy

Drug: Blood pressure lowering therapy

Behavioral: Stop smoking

Drug: Glucose lowering therapy

Behavioral: Exercise