BOSTON — Intensive treatment with multiple oral hypoglycemics and insulin can bring glucose and blood pressure levels within acceptable values in patients with poorly controlled type 2 diabetes, Dr. William Duckworth said at the annual meeting of the Endocrine Society.
Interim results of the 7-year Veterans Administration Diabetes Trial (VADT) also show that intensive therapy improved lipid levels and stabilized ophthalmic microvascular disease, said Dr. Duckworth, VADT's lead investigator and the director of diabetes research at the Carl T. Hayden Veterans Affairs Medical Center, Phoenix.
VADT will assess the impact of long-term intensive glucose control on cardiovascular and microvascular disease in 1,792 older patients who had poorly controlled type 2 diabetes at study entry and were randomized to standard or intensive therapy. At baseline, the patients' mean age was 60 years and mean duration of diabetes was 11.5 years. Mean hemoglobin A1c level was 9.4%, mean body mass index was 30 kg/m
Both groups began therapy with metformin (for obese patients) or glimepiride (for lean patients). If their daily glucose goals were unmet, rosiglitazone was added, followed by insulin if necessary to achieve the goal. The major difference between the groups was the HbA1c target: For the intensive treatment group, the target is 6% or less; for the standard treatment group, it is 8%–9%.
Within 1 year, the mean HbA1c level fell to 7% in the intensive therapy group and to 8.5% in the standard therapy group. By year 4, the level in the intensive therapy group had decreased to 6.75%, but it remained steady in the standard therapy group. Also by year 4, almost all of the patients were on combination oral therapy, and the percentage on insulin had risen from 50% to 80%. The mean insulin dosage was 50 units/day in the intensive treatment group and 40 units/day in the standard treatment group.
“Surprisingly, the amount of insulin needed actually decreased from baseline in both groups, and it isn't all that much compared to what we usually think of as necessary in a group like this,” Dr. Duckworth said.
Blood pressure improved significantly by year 4 in both groups, he said, decreasing from a mean of 131/77 mm Hg to 125/70 mm Hg. Lipid profiles also improved in both groups: Triglycerides declined from 161 mg/dL to 143 mg/dL, LDL cholesterol was reduced from 104 mg/dL to 89 mg/dL, and HDL cholesterol rose from 34 mg/dL to 38 mg/dL. Albumin/creatinine levels did not significantly change from their mean baseline value of 70 mg/g.
Based on routine exams, retinopathy “hasn't gone away, but it certainly hasn't gotten any worse,” Dr. Duckworth said.
The trial is being supported by GlaxoSmithKline, Sanofi-Aventis, Novo Nordisk, and Roche Diagnostics as well as the Veterans Administration.
'Surprisingly, the amount of insulin needed actually decreased from baseline in both groups.' DR. DUCKWORTH