At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus no longer responsive to maximum dose of one or more oral agents
- ✕Angina pectoris Canadian Class I-II
- ✕Congestive heart failure Class III-IV
- ✕Stroke that is incapacitating or within last 6 months
- ✕Myocardial infarction or invasive cardiovascular procedure within past 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CSP #465 - Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
In Brief
A Phase 3 clinical trial evaluating Insulin, Glimepiride, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 1,791 participants across 21 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs Arm 1 Insulin (intermediate or long-lasting) in a.m. 1 unit 9 lbs, add one injection of insulin Arm 2
Glimepiride 2 mg Arm 1 Glimepiride 8 mg Arm 2
Rosiglitazone 4 mg Arm 1 Rosiglitazone 4 mg bid Arm 2
Metformin 500 mg (go up to 1000 mg) Arm 1 Metformin 500 mg (go up to 2000 mg) Arm