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NCT00859898 · ClinicalTrials.gov registry record · Phase 3
Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,093
- Enrollment target
NCT00859898: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00859898 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 1,093 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00859898, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,093 participants
- Enrollment target
Study Summary
The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study
Primary Outcome
Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of th
Interventions
- DRUG Dapagliflozin
- DRUG Metformin XR
- DRUG dapagliflozin matching Placebo
- DRUG metformin HCl Modified Release matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,093 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
What the finished NCT00859898 record still lists
NCT00859898 is an interventional study that assigns participants to a tested intervention. Its 1,093 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 (42% higher).
The record links to 0 conditions, and to 4 interventions - of which Dapagliflozin is the first listed.
NCT00859898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00859898 about?
NCT00859898 is a clinical study titled "Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes". The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind t...
What is the current status of trial NCT00859898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,093 participants. The study started on 2009-04. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00859898?
The interventions under investigation include: Dapagliflozin (DRUG), Metformin XR (DRUG), dapagliflozin matching Placebo (DRUG), metformin HCl Modified Release matching Placebo (DRUG).
Who is sponsoring clinical trial NCT00859898?
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 NCT00859898's enrollment target sits among peer trials
1,093 266th of 2000 higher than 1,735 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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