Amlexanox for Type 2 Diabetes and Obesity

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring diabetes mellitus type 2, non alcoholic fatty liver disease, obesity, amlexanox Read More

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 [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 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.