CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Amlexanox +1 moredrug
Likely dose
Amlexanox 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01975935
NCT01975935Phase 2Completed
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Clinical Protocol to Investigate the Efficacy of Amlexanox vs. Placebo for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 Diabetics

University of Michigan·interventional·Posted Nov 5, 2013·Updated Nov 7, 2018

In Brief

A Phase 2 clinical trial evaluating Amlexanox and Placebo for Diabetes Mellitus Type 2 and 2 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus Type 2, Non-alcoholic Fatty Liver Disease, Obesity
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartJan 1, 2014
Primary CompletionApr 25, 2016
Study CompletionAug 18, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.7 years ago

Interventions

Amlexanoxdrug

25 mg amlexanox tablets blinded by encapsulation

Placebodrug

placebo sham blinded by encapsulation in the same capsules as the study drug arm