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NCT01031680 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 922
- Enrollment target
NCT01031680: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01031680 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 922 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01031680, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 922 participants
- Enrollment target
Study Summary
This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.
Primary Outcome
To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.
Interventions
- DRUG Placebo
- DRUG Dapagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 922 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01031680 record still lists
NCT01031680 is an interventional study that assigns participants to a tested intervention. The registered 922 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01031680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01031680 about?
NCT01031680 is a clinical study titled "Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension". This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment...
What is the current status of trial NCT01031680?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 922 participants. The study started on 2010-02. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01031680?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT01031680?
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 NCT01031680's enrollment target sits among peer trials
922 344th of 2000 higher than 1,656 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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