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NCT02419612 · ClinicalTrials.gov registry record · Phase 3
A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 444
- Enrollment target
NCT02419612: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02419612 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 444 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02419612, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 444 participants
- Enrollment target
Study Summary
This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.
Primary Outcome
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.
Interventions
- OTHER Placebo
- DRUG Dapagliflozin
- DRUG Saxagliptin
- DRUG Glimepiride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2015-08-14 |
| Est. Completion | 2019-09-18 |
| Phase | Phase 3 |
What the finished NCT02419612 record still lists
NCT02419612 is an interventional study that assigns participants to a tested intervention. The registered 444 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 (42% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02419612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02419612 about?
NCT02419612 is a clinical study titled "A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone". This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes ...
What is the current status of trial NCT02419612?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 444 participants. The study started on 2015-08-14. Estimated completion is 2019-09-18.
What interventions are being tested in trial NCT02419612?
The interventions under investigation include: Placebo (OTHER), Dapagliflozin (DRUG), Saxagliptin (DRUG), Glimepiride (DRUG).
Who is sponsoring clinical trial NCT02419612?
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 NCT02419612's enrollment target sits among peer trials
444 864th of 2000 higher than 1,135 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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