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NCT01646320 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 320
- Enrollment target
NCT01646320: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01646320 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 320 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01646320, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 320 participants
- Enrollment target
Study Summary
The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
Primary Outcome
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 the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtai
Interventions
- DRUG Dapagliflozin
- DRUG Saxagliptin
- DRUG Placebo matching with Dapagliflozin
- DRUG Metformin immediate release (IR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT01646320 record still lists
NCT01646320 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 4 interventions - of which Dapagliflozin is the first listed.
NCT01646320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01646320 about?
NCT01646320 is a clinical study titled "Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes". The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be stu...
What is the current status of trial NCT01646320?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2012-09. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01646320?
The interventions under investigation include: Dapagliflozin (DRUG), Saxagliptin (DRUG), Placebo matching with Dapagliflozin (DRUG), Metformin immediate release (IR) (DRUG).
Who is sponsoring clinical trial NCT01646320?
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 NCT01646320's enrollment target sits among peer trials
320 1082nd of 2000 higher than 914 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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