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NCT00032487 · ClinicalTrials.gov registry record · Phase 3
Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,791
- Enrollment target
NCT00032487: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT00032487 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 1,791 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00032487, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,791 participants
- Enrollment target
Study 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.
Primary Outcome
Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene.
Interventions
- DRUG Metformin
- DRUG Rosiglitazone
- DRUG Insulin
- DRUG Glimepiride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,791 participants |
| Start Date | 2000-12-01 |
| Est. Completion | 2008-05-30 |
| Phase | Phase 3 |
What the finished NCT00032487 record still lists
NCT00032487 is an interventional study that assigns participants to a tested intervention. Its 1,791 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT00032487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00032487 about?
NCT00032487 is a clinical study titled "Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)". 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 stud...
What is the current status of trial NCT00032487?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,791 participants. The study started on 2000-12-01. Estimated completion is 2008-05-30.
What interventions are being tested in trial NCT00032487?
The interventions under investigation include: Metformin (DRUG), Rosiglitazone (DRUG), Insulin (DRUG), Glimepiride (DRUG).
Who is sponsoring clinical trial NCT00032487?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00032487's enrollment target sits among peer trials
1,791 125th of 2000 higher than 1,876 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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