Status:
TERMINATED
Amlexanox for Type 2 Diabetes and Obesity
Lead Sponsor:
University of Michigan
Conditions:
Diabetes Mellitus Type 2
Non Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
July 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01842282
Start Date
July 19 2013
End Date
February 25 2014
Last Update
May 7 2024
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109