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COMPLETED Phase 2

Study of AC-201 in Patients With Type 2 Diabetes Mellitus

NCT01276106 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 259 participants
Start Date 2011-01
Est. Completion 2012-03
Phase Phase 2

Sponsor

TWi Biotechnology

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01276106

The ClinicalTrials.gov registry entry for NCT01276106 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TWi Biotechnology, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01276106 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01276106?

This trial is sponsored by TWi Biotechnology, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial