Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
Status:
Completed
Trial end date:
2008-05-30
Target enrollment:
Participant gender:
Summary
This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic
control, achieved through intensification of treatment, is effective in preventing clinical
macrovascular complications in patients with type 2 DM who are no longer responsive to oral
agents alone. The study consists of a two-year accrual period and five years of follow-up (7
years total) of 1700 patients across 20 centers. We have powered the study to detect a 21%
reduction in the primary event rate. Additional study goals are to determine whether the
expenditures, discomfort, and adverse effects associated with intensive intervention are
justified in terms of their clinical benefits, considering both macrovascular and
microvascular complications.