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NCT02681094 · ClinicalTrials.gov registry record · Phase 3
A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 905
- Enrollment target
NCT02681094: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02681094 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 905 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02681094, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 905 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.
Primary Outcome
To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set. Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication.
Interventions
- DRUG Dapagliflozin
- DRUG Saxagliptin
- DRUG Placebo for Dapagliflozin
- DRUG Placebo for Saxagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 905 participants |
| Start Date | 2016-02-26 |
| Est. Completion | 2017-07-15 |
| Phase | Phase 3 |
What the finished NCT02681094 record still lists
NCT02681094 is an interventional study that assigns participants to a tested intervention. The registered 905 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 (17% higher).
The record links to 0 conditions, and to 4 interventions - of which Dapagliflozin is the first listed.
NCT02681094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02681094 about?
NCT02681094 is a clinical study titled "A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes". The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.
What is the current status of trial NCT02681094?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 905 participants. The study started on 2016-02-26. Estimated completion is 2017-07-15.
What interventions are being tested in trial NCT02681094?
The interventions under investigation include: Dapagliflozin (DRUG), Saxagliptin (DRUG), Placebo for Dapagliflozin (DRUG), Placebo for Saxagliptin (DRUG).
Who is sponsoring clinical trial NCT02681094?
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 NCT02681094's enrollment target sits among peer trials
905 347th of 2000 higher than 1,653 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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