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

NCT01276106 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2018-05-22

Study results available
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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

Interventions

DRUG

AC-201, 25mg

Capsule, 25mg BID

DRUG

AC-201, 50mg

Capsule, 50mg BID

DRUG

AC-201, 75mg

Capsule, 75mg BID

DRUG

Placebo

Placebo BID

Sponsors & Collaborators

  • TWi Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • United States
  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01276106 on ClinicalTrials.gov