Clinical trial NCT01975935 (phase 2, status: completed)
Conditions: diabetes mellitus type 2, non-alcoholic fatty liver disease, obesity
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44, Z52.6, K71.8, K71.7, A06.4, C22.0, C22.3, K70.0, E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: amlexanox, placebo
SMILES: CC(C)C1=CC2=C(OC3=NC(N)=C(C=C3C2=O)C(O)=O)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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 <45 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, or other injectables for treatment of Type 2 diabetes.

          -  Unable to conduct home based glucose monitoring.

          -  HbA1c <6.5% and >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.