drugset / Trial / NCT01276106

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

NCT01276106 ↗

Phase 2 Completed 259 enrolled TWi Biotechnology, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2011-01
Primary completion
2012-02
Completion
2012-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); AC-201, 75mg BID vs Placebo; p = 0.044; Mean Difference (Final Values) -0.35 (95% CI -0.70 to -0.01) NCT01276106 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Diacerein Small molecule 25 mg Oral
Subject Diacerein Small molecule 50 mg Oral
Subject Diacerein Small molecule 75 mg Oral