drugset / Trial / NCT01842282

Amlexanox for Type 2 Diabetes and Obesity

NCT01842282 ↗

Phase 2 Terminated 7 enrolled University of Michigan
NaSingle-groupOpen-labelTreatment

Summary

This study involves the use of a research drug, Amlexanox, for the treatment of type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). Amlexanox is taken orally in a pill three times a day. The investigators plan to continue therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body). Seven eligible subjects in this study will also be evaluated for a change in liver disease by a liver biopsy.

Timeline

Start
2013-07-19
Primary completion
2014-02-25
Completion
2014-02-25

Outcome

Outcome not reported

Stopped (Business): “Due to limited funding, trial was suspended, intending to restart with additional funds; then preliminary results were obtained, and research moved on to placebo controlled trial. Results for both have been published.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlexanox Small molecule — Oral