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NCT01023581 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 784
- Enrollment target
- 20
- Study locations
NCT01023581: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Takeda.
NCT01023581 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Takeda. The registered enrollment target is 784 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01023581, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 784 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.
Primary Outcome
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Alogliptin
- DRUG Alogliptin Placebo
- DRUG Metformin Placebo
Study Locations (20)
California
- - Anaheim
- - Buena Park
- - Cathedral City
- - National City
- - Pismo Beach
- - Roseville
- - Santa Ana
Arizona
- - Chandler
- - Mesa
- - Phoenix
- - Sierra Vista
- - Tempe
Alabama
- - Dothan
- - Muscle Shoals
- - Pell City
Arkansas
- - Little Rock
- - Searcy
- - Tempe
Colorado
- - Colorado Springs
Florida
- - Boca Raton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 784 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
What the finished NCT01023581 record still lists
NCT01023581 is an interventional study that assigns participants to a tested intervention. The registered 784 participants enrollment target is mid-sized for trials with a published cap, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 4 interventions - of which Metformin is the first listed.
NCT01023581 names 20 study sites across 6 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01023581 about?
NCT01023581 is a clinical study titled "Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes". The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.
What is the current status of trial NCT01023581?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 784 participants. The study started on 2009-11. Estimated completion is 2011-06.
What conditions does trial NCT01023581 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01023581?
The interventions under investigation include: Metformin (DRUG), Alogliptin (DRUG), Alogliptin Placebo (DRUG), Metformin Placebo (DRUG).
Who is sponsoring clinical trial NCT01023581?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01023581 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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 NCT01023581's enrollment target sits among peer trials
784 47th of 348 higher than 302 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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