Amlexanox for Type 2 Diabetes and Obesity

This study is currently recruiting participants.
Verified April 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Elif Oral, University of Michigan
ClinicalTrials.gov Identifier:
NCT01842282
First received: April 24, 2013
Last updated: April 26, 2013
Last verified: April 2013

April 24, 2013
April 26, 2013
April 2013
May 2015   (final data collection date for primary outcome measure)
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    improvement in HbA1c
  • hepatic steatosis by MRI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    improvement in hepatic steatosis by MRI
Same as current
Complete list of historical versions of study NCT01842282 on ClinicalTrials.gov Archive Site
Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
weight decrease
Same as current
Not Provided
Not Provided
 
Amlexanox for Type 2 Diabetes and Obesity
Clinical Protocol to Investigate the Efficacy of Amlexanox for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 Diabetics

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 a pill three times a day. The investigators plan to continue therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body). Seven eligible subjects in this study will also be evaluated for a change in liver disease by a liver biopsy.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus Type 2
  • Non Alcoholic Fatty Liver Disease
  • Obesity
Drug: Amlexanox
Other Name: Solfa tablets
Experimental: Amlexanox
Intervention: Drug: Amlexanox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Not Provided
May 2015   (final data collection date for primary outcome measure)

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.
  • 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.
Both
18 Years to 59 Years
No
Not Provided
United States
 
NCT01842282
HUM00065177
No
Elif Oral, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Elif A Oral, MD Univeristy of Michigan
University of Michigan
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP