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NCT00683657 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 93
- Enrollment target
NCT00683657: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00683657 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 93 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00683657, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 93 participants
- Enrollment target
Study Summary
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
Primary Outcome
Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24
Interventions
- DRUG Placebo
- DRUG Saxagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00683657 record still lists
NCT00683657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00683657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00683657 about?
NCT00683657 is a clinical study titled "Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone". This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
What is the current status of trial NCT00683657?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2008-07. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00683657?
The interventions under investigation include: Placebo (DRUG), Saxagliptin (DRUG).
Who is sponsoring clinical trial NCT00683657?
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 NCT00683657's enrollment target sits among peer trials
93 1722nd of 2000 higher than 278 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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