Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2017-08-18
• Target enrollment: 0
• Participant gender: All

Summary

This study involves research about an investigational medicine called Amlexanox. The reason for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered to be investigational (not approved by the Food and Drug Administration [FDA]) for type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is a placebo controlled study. There is a 50-50 chance that the patient may either receive the study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors will know if the patient is receiving the study drug or placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Amlexanox

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.