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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00032487
The ClinicalTrials.gov registry entry for NCT00032487 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,791 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT00032487 reports 0 study locations.
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.
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