Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients

Summary

This study involves research about an investigational medicine called Amlexanox. The reason for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered to be investigational (not approved by the Food and Drug Administration \[FDA\]) for type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is a placebo controlled study. There is a 50-50 chance that the patient may either receive the study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors will know if the patient is receiving the study drug or placebo.

Timeline

Start

2014-01

Primary completion

2016-04-25

Completion

2017-08-18

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Amlexanox; p = 0.05; t-test, 2 sided; NCT01975935 ↗

Drugs

Indications