Amlexanox for Type 2 Diabetes and Obesity

Study Description

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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 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 or disease	Intervention/treatment	Phase
Diabetes Mellitus Type 2; Non Alcoholic Fatty Liver Disease; Obesity	Drug: Amlexanox	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	15 participants
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
Actual Study Start Date :	July 19, 2013
Estimated Primary Completion Date :	October 2019
Estimated Study Completion Date :	December 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Amlexanox	Drug: Amlexanox; Other Name: Solfa tablets

Outcome Measures

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Primary Outcome Measures :

1. HbA1c [ Time Frame: 12 weeks ]
   improvement in HbA1c
2. hepatic steatosis by MRI [ Time Frame: 12 weeks ]
   improvement in hepatic steatosis by MRI

Secondary Outcome Measures :

1. Weight [ Time Frame: 12 weeks ]
   weight decrease

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted:	April 29, 2013
Last Update Posted:	November 6, 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