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NCT01481116 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,454
- Enrollment target
NCT01481116: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT01481116 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 2,454 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (218% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01481116, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,454 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM). The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM).
Primary Outcome
The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.
Interventions
- DRUG Glimepiride
- DRUG TAK-875
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,454 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
Why NCT01481116 stopped before completion
NCT01481116 is an interventional study that assigns participants to a tested intervention. Its 2,454 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 (218% higher).
The record links to 0 conditions, and to 2 interventions - of which Glimepiride is the first listed.
NCT01481116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01481116 about?
NCT01481116 is a clinical study titled "Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes". The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), plus metformin compared to glimepiride plus metformin in participants with type 2 diabetes mellitus (T2DM). The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), p...
What is the current status of trial NCT01481116?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,454 participants. The study started on 2012-01. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01481116?
The interventions under investigation include: Glimepiride (DRUG), TAK-875 (DRUG).
Who is sponsoring clinical trial NCT01481116?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01481116's enrollment target sits among peer trials
2,454 88th of 2000 higher than 1,913 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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