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NCT01549964 · ClinicalTrials.gov registry record · Phase 3
Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 916
- Enrollment target
NCT01549964: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT01549964 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 916 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01549964, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 916 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50 mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus metformin on lowering blood sugar.
Primary Outcome
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A Mixed Model Repeated Measures (MMRM) model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.
Interventions
- DRUG Placebo
- DRUG Sitagliptin
- DRUG Fasiglifam (TAK-875)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 916 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
Why NCT01549964 stopped before completion
NCT01549964 is an interventional study that assigns participants to a tested intervention. The registered 916 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 (19% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01549964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01549964 about?
NCT01549964 is a clinical study titled "Comparison of Fasiglifam (TAK-875) to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes". The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50 mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus metformin on lowering blood sugar.
What is the current status of trial NCT01549964?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 916 participants. The study started on 2012-04. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01549964?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG), Fasiglifam (TAK-875) (DRUG).
Who is sponsoring clinical trial NCT01549964?
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 NCT01549964's enrollment target sits among peer trials
916 347th of 2000 higher than 1,654 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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