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NCT00676338 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 820
- Enrollment target
NCT00676338: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00676338 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 820 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00676338, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 820 participants
- Enrollment target
Study Summary
This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.
Primary Outcome
Change in HbA1c from baseline to Week 26.
Interventions
- DRUG metformin
- DRUG pioglitazone
- DRUG sitagliptin
- DRUG exenatide once weekly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 820 participants |
| Start Date | 2008-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
What the finished NCT00676338 record still lists
NCT00676338 is an interventional study that assigns participants to a tested intervention. The registered 820 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which metformin is the first listed.
NCT00676338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00676338 about?
NCT00676338 is a clinical study titled "Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)". This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.
What is the current status of trial NCT00676338?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 820 participants. The study started on 2008-11. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00676338?
The interventions under investigation include: metformin (DRUG), pioglitazone (DRUG), sitagliptin (DRUG), exenatide once weekly (DRUG).
Who is sponsoring clinical trial NCT00676338?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00676338's enrollment target sits among peer trials
820 404th of 2000 higher than 1,596 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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