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Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01975935
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : May 9, 2017
Last Update Posted : November 7, 2018
Information provided by (Responsible Party):
Elif Oral, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Non-alcoholic Fatty Liver Disease Obesity Drug: Amlexanox Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Protocol to Investigate the Efficacy of Amlexanox vs. Placebo for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 Diabetics
Study Start Date : January 2014
Actual Primary Completion Date : April 25, 2016
Actual Study Completion Date : August 18, 2017

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks
Drug: Placebo
placebo sham blinded by encapsulation in the same capsules as the study drug arm

Experimental: Amlexanox
Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks
Drug: Amlexanox
25 mg amlexanox tablets blinded by encapsulation
Other Name: Solfa tablets

Primary Outcome Measures :
  1. Difference in Hemoglobin A1c Values [ Time Frame: 12 weeks (measured at baseline and 12 weeks) ]
    Difference in hemoglobin A1c as measured at baseline and week 12 visits

Secondary Outcome Measures :
  1. Hepatic Steatosis as Measured by MRI [ Time Frame: 12 weeks ]
    Improvement in hepatic steatosis by MRI is shown by a decrease in percent fat from baseline to week 12 visit.

  2. Change in Weight [ Time Frame: 12 week ]
    Change in weight (kilograms) as measured at baseline and week 12 visits.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01975935

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Responsible Party: Elif Oral, Associate Professor, Internal Medicine, University of Michigan Identifier: NCT01975935    
Other Study ID Numbers: HUM00079381
First Posted: November 5, 2013    Key Record Dates
Results First Posted: May 9, 2017
Last Update Posted: November 7, 2018
Last Verified: October 2018
Keywords provided by Elif Oral, University of Michigan:
diabetes mellitus type 2
non-alcoholic fatt liver disease
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
Anti-Allergic Agents