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Amlexanox for Type 2 Diabetes and Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01842282
First Posted: April 29, 2013
Last Update Posted: November 2, 2017
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.
Information provided by (Responsible Party):
Elif Oral, University of Michigan
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus Type 2 Non Alcoholic Fatty Liver Disease Obesity Drug: Amlexanox Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Protocol to Investigate the Efficacy of Amlexanox for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by Elif Oral, University of Michigan:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ]
    improvement in HbA1c

  • hepatic steatosis by MRI [ Time Frame: 12 weeks ]
    improvement in hepatic steatosis by MRI


Secondary Outcome Measures:
  • Weight [ Time Frame: 12 weeks ]
    weight decrease


Estimated Enrollment: 15
Actual Study Start Date: July 19, 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amlexanox Drug: Amlexanox
Other Name: Solfa tablets

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01842282


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Elif A Oral, MD Univeristy of Michigan
  More Information

Responsible Party: Elif Oral, Associate Professor of Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01842282     History of Changes
Other Study ID Numbers: HUM00065177
First Submitted: April 24, 2013
First Posted: April 29, 2013
Last Update Posted: November 2, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elif Oral, University of Michigan:
diabetes mellitus type 2
non alcoholic fatty liver disease
obesity
amlexanox

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Digestive System Diseases
Amlexanox
Anti-Allergic Agents