Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients

Inclusion Criteria

• ≥ 18 years old at baseline.
• 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 [βhCG]) 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.
• BMI ≥27 and 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, or other injectables for treatment of Type 2 diabetes.
• Unable to conduct home based glucose monitoring.
• HbA1c 10.0% (set to achieve uniformity in the study population).
• 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.