The STENO-2 Trial (1999)

Diabetes is a difficult disease to treat. The disease can progress with seemingly appropriate medication prescription as management of this disease requires changing an entire lifestyle. For a patient to thrive, it requires management of diabetes, blood pressure, hyperlipidemia, and addressing the associated increased cardiovascular risk. The STENO-2 Trial was one of the main trials that addressed multifactorial risk factor reduction for patients wtih diabetes. This trial enrolled 160 diabetic patients between the ages of 40-65 years old with microalbuminuria (defined as urine albumin excretion rates of 30-300 mg/day -- in line with CKD stage A2 albuminuria). Patients were randomized to conventional therapy or an intensive therapy regimen which included lifestyle modification (low fat diet, light/moderate exercise 3-5 days per week, smoking cessation, vitamin C, vitamin E), blood glucose control to a Hb A1c of <6.5%, BP goal of <140/90 for the initial part of the trial and then <130/80 for the latter part of the trial. They also placed patients on an ACE regardless of BP, lipid-lowering therapy, and aspirin. Both the conventional therapy arm and intensive therapy arm received individualized diabetic dietary advice. The primary endpoint was a composite endpoint of cardiovascular death, non-fatal MI, CABG, stroke, amputation, or peripheral vascular surgery). After a mean follow-up of 7.8 years, patients in the intensive therapy arm had a risk reduction of 57%. The intensive therapy arm also had lower rates of progression to nephropathy, progression of retinopathy, and progression of autonomic therapy. Being a multifactorial risk reduction study, this study addressed the marked benefit of controlling diabetes from every angle. Using multiple interventions, it could not determine which intervention had the most benefit, but this particular question was not the main aim of the trial. Overall, this was a nice study that shows the benefit of what we try to accomplish for diabetic patients in our clinic. 

The STENO-2 Trial: Gæde, P., Vedel, P., Parving, H. H., & Pedersen, O. (1999). Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. The Lancet, 353(9153), 617-622.

The STENO-2 Trial PMID: 10030326