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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01842282
Other study ID # HUM00065177
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 19, 2013
Est. completion date February 25, 2014

Study information

Verified date April 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date February 25, 2014
Est. primary completion date February 25, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - = 18 years old at baseline and <60 years of age. - Is male, female not of childbearing potential, or meets all the following criteria if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year): - Not breastfeeding. - Negative pregnancy test result (human chorionic gonadotropin, beta subunit [ßhCG]) at baseline (not applicable to hysterectomized females). - Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate when use consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of study period. - Has physician-confirmed diabetes mellitus with a clear diagnosis or per ADA criteria with fasting glucose>126 mg/dL or HbA1c >6.4% or 2 hour GTT >200 mg/dL or or pre-diabetes with fasting glucose >100 mg/dL (n= up to 8) - BMI =27 and <36 kg/m2. - On no medications or only on first line oral medications (such as Metformin and/or DPP IV inhibitors) for treatment of type 2 diabetes mellitus with a stable regimen for >12 weeks. - Alcohol consumption of less than 40 grams/week. - A liver US confirming presence of fatty infiltration of the liver. - Is able to read, understand and sign the U of M IRBMED approved informed consent form (ICF), communicate with study physician and study team, understand and comply with protocol requirements. Exclusion Criteria: - On insulin, sulfonylurea or other injectables for treatment of type 2 diabetes - Unable to conduct home based glucose monitoring - HbA1c>9.5% - Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal PT or albumin). - Evidence of other etiologies of viral hepatitis. - Presence of hematologic, bone marrow and/or other abnormalities. - Presence of hemoglobinopathy or other hematological abnormalities that will interfere with accurate measurement of HbA1c - Presence of HIV infection. - Inability to give informed consent. - Presence of ESRD, any type of active cancer, or >class 2 congestive heart failure (New York Heart Association Functional Classification System), based on medical history and physical examination. - Active chronic infection such as known chronic osteomyelitis or tb, etc. (may be transient). - Creatinine >1.5 mg/dL - Proliferative diabetic retinopathy, nonproliferative retinopathy is allowed - Unable to ambulate - Clinically relevant CAD: history of stent, CABG or cardiologist confirmed angina - Any other condition in the opinion of the investigators that may impede successful data collection.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Amlexanox


Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c Change in HbA1c from baseline to 12 weeks as shown by mean increase or decrease of HbA1c where decreased values represent better health 12 weeks
Primary Hepatic Steatosis by MRI change in hepatic steatosis from baseline to 12 weeks: MRI Liver fat percentage as shown by mean difference 12 weeks
Secondary Weight Change in weight (Kg) from baseline to 12 weeks as shown by mean difference, where lower weights represent healthier outcomes 12 weeks
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