| Trial ID: | L4290 |
| Source ID: | NCT01975935
|
| Associated Drug: |
Amlexanox
|
| Title: |
Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01975935/results
|
| Conditions: |
Diabetes Mellitus Type 2|Non-alcoholic Fatty Liver Disease|Obesity
|
| Interventions: |
DRUG: Amlexanox|DRUG: Placebo
|
| Outcome Measures: |
Primary: Difference in Hemoglobin A1c Values, Difference in hemoglobin A1c as measured at baseline and week 12 visits, 12 weeks (measured at baseline and 12 weeks) | Secondary: Hepatic Steatosis as Measured by MRI, Improvement in hepatic steatosis by MRI is shown by a decrease in percent fat from baseline to week 12 visit., 12 weeks|Change in Weight, Change in weight (kilograms) as measured at baseline and week 12 visits., 12 week
|
| Sponsor/Collaborators: |
Sponsor: University of Michigan
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
|
| Completion Date: |
2017-08-18
|
| Results First Posted: |
2017-05-09
|
| Last Update Posted: |
2018-11-07
|
| Locations: |
University of Michigan, Ann Arbor, Michigan, 48109, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01975935
|
