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NCT01276106 · ClinicalTrials.gov registry record · Phase 2
Study of AC-201 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study of Type 2 Diabetes Mellitus, sponsored by TWi Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 259
- Enrollment target
- 20
- Study locations
NCT01276106: Completed Phase 2 study of Type 2 Diabetes Mellitus, sponsored by TWi Biotechnology.
NCT01276106 is a Phase 2 study of Type 2 Diabetes Mellitus that has completed, run by TWi Biotechnology. The registered enrollment target is 259 participants, below the 2,958-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01276106, a Phase 2 study of Type 2 Diabetes Mellitus, has completed, sponsored by TWi Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 259 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 24-week randomized placebo-controlled study to investigate the effect of an oral IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on different background diabetes therapies.
Primary Outcome
For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p\<0.05.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AC-201, 25mg
- DRUG AC-201, 50mg
- DRUG AC-201, 75mg
Study Locations (20)
Other
- Changhua Christian Hospital - Changhua
- Cheng Ching General Hospital - Taichung
- Chung Shan Medical University Hospital - Taichung
- Kuang Tien General Hospital - Taichung
- Cardinal Tien Hospital - Taipei
- Taipei Medical University Hospital - Taipei
- Taipei Medical University-Shuang Ho Hospital - Taipei
California
- Catalina Research Institute, LLC - Chino
- National Research Institute - Los Angeles
Florida
- Clinical Research of South Florida - Coral Gables
- Jacksonville Impotence Treatment Center - Jacksonville
Illinois
- Chicago Clinical Research Institute, Inc. - Chicago
- Clinical Investigation Specialists, Inc. - Gurnee
Ohio
- Sterling Research Group, Ltd - Cincinnati
- PriMed Clinical Research - Kettering
Indiana
- Midwest Institute for Clinical Research, Inc. - Indianapolis
Kentucky
- L-MARC Research Center - Louisville
Louisiana
- New Orleans Center for Clinical Research - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT01276106 record still lists
NCT01276106 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, below the 2,958-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01276106 names 20 study sites across 10 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01276106 about?
NCT01276106 is a clinical study titled "Study of AC-201 in Patients With Type 2 Diabetes Mellitus". This is a 24-week randomized placebo-controlled study to investigate the effect of an oral IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on different background diabetes therapies.
What is the current status of trial NCT01276106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 259 participants. The study started on 2011-01. Estimated completion is 2012-03.
What conditions does trial NCT01276106 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT01276106?
The interventions under investigation include: Placebo (DRUG), AC-201, 25mg (DRUG), AC-201, 50mg (DRUG), AC-201, 75mg (DRUG).
Who is sponsoring clinical trial NCT01276106?
This trial is sponsored by TWi Biotechnology, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01276106 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
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 NCT01276106's enrollment target sits among peer trials
259 30th of 130 higher than 101 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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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