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NCT01042977 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 964
- Enrollment target
NCT01042977: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01042977 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 964 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01042977, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 964 participants
- Enrollment target
Study Summary
This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's 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 and cardiovascular disease
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, measured as the mean change in HbA1c from baseline to week 24.
Interventions
- DRUG Placebo
- DRUG Dapagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 964 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01042977 record still lists
NCT01042977 is an interventional study that assigns participants to a tested intervention. The registered 964 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 (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01042977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01042977 about?
NCT01042977 is a clinical study titled "Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease". This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be co...
What is the current status of trial NCT01042977?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 964 participants. The study started on 2010-03. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01042977?
The interventions under investigation include: Placebo (DRUG), Dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT01042977?
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 NCT01042977's enrollment target sits among peer trials
964 330th of 2000 higher than 1,671 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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