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NCT01456195 · ClinicalTrials.gov registry record · Phase 3
Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 421
- Enrollment target
- 20
- Study locations
NCT01456195: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Takeda.
NCT01456195 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Takeda. The registered enrollment target is 421 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456195, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 421 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).
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 with treatment, country, 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 was used for analysis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fasiglifam
Study Locations (20)
Florida
- - Boynton Beach
- - Bradenton
- - Coral Gables
- - Hialeah
- - Largo
- - New Port Richey
- - Orlando
- - Pembroke Pines
California
- - Long Beach
- - North Hollywood
- - Norwalk
- - Palm Springs
- - Pismo Beach
Alabama
- - Dothan
- - Muscle Shoals
Arizona
- - Goodyear
- - Phoenix
Georgia
- - Decatur
Illinois
- - Chicago
Indiana
- - Avon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 421 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01456195 record still lists
NCT01456195 is an interventional study that assigns participants to a tested intervention. The registered 421 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01456195 names 20 study sites across 7 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01456195 about?
NCT01456195 is a clinical study titled "Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes". The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).
What is the current status of trial NCT01456195?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 421 participants. The study started on 2011-11. Estimated completion is 2013-07.
What conditions does trial NCT01456195 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01456195?
The interventions under investigation include: Placebo (DRUG), Fasiglifam (DRUG).
Who is sponsoring clinical trial NCT01456195?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01456195 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01456195's enrollment target sits among peer trials
421 88th of 348 higher than 261 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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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