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NCT01606007 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,282
- Enrollment target
NCT01606007: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01606007 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 1,282 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01606007, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,282 participants
- Enrollment target
Study Summary
The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.
Primary Outcome
HbA1c was measured as percent of hemoglobin by a central laboratory. 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 obtained at Week 24 in the double-blind period, including observations prior to rescue.
Interventions
- DRUG Dapagliflozin
- DRUG Saxagliptin
- DRUG Metformin XR
- DRUG Placebo matching with Saxagliptin
- DRUG Placebo matching with Dapagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,282 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01606007 record still lists
NCT01606007 is an interventional study that assigns participants to a tested intervention. Its 1,282 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 (66% higher).
The record links to 0 conditions, and to 5 interventions - of which Dapagliflozin is the first listed.
NCT01606007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01606007 about?
NCT01606007 is a clinical study titled "Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes". The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also b...
What is the current status of trial NCT01606007?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,282 participants. The study started on 2012-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01606007?
The interventions under investigation include: Dapagliflozin (DRUG), Saxagliptin (DRUG), Metformin XR (DRUG), Placebo matching with Saxagliptin (DRUG), Placebo matching with Dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT01606007?
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 NCT01606007's enrollment target sits among peer trials
1,282 198th of 2000 higher than 1,803 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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